Cancer Symptoms & Treatment
Receiving a diagnosis of cancer presents numerous challenges: learning about your disease, selecting the physicians who will care for you, and making decisions about your treatment. Then come the day-today challenges: integrating the treatment schedule into your life, coping with the symptoms and side effects of the treatments, and finally making the transition to being a cancer survivor.
We hope our texts will provide information and support to help you in meeting these challenges. We have included information about cancer and cancer treatment, but the focus is on managing the symptoms of the disease and the side effects of treatment. Equally important is information we hope will help you and your family cope with the emotional and practical concerns that come up during this time.
(1) What is a cancer?
Cancer is a term used to describe over a hundred different diseases with certain features in common. A cancer begins with a change in the structure and function of a cell that causes the cell to divide and multiply out of control.
(2) Cancer Symptoms & Treatments
Why does cancer cause symptoms?
The symptoms of a cancer depend on where it begins and how it grows. If the tumor is close to the surface of the body, you might see a lump or swelling, a change in color of the skin or mucous membranes, a sore that doesn’t heal, or bleeding. If the tumor is deep within the body, you might not have symptoms until the tumor grows large enough to press on other structures, perhaps blocking a passageway and causing an obstruction. For example, a blockage of an airway in the lung can cause a cough, blockage of the intestine can cause constipation or vomiting, and blockage of the bile duct can cause jaundice.
As a tumor grows, it can cause pain by putting pressure on different parts of the body. A tumor may also cause fluid to accumulate in the body. The abnormal buildup of fluid in the abdominal cavity is called ascites, which can cause swelling and pain in the belly. The abnormal buildup of fluid in the chest cavity is called pleural effusion, which can cause a cough and shortness of breath.
Symptoms from a cancer may not develop until the tumor has metastasized. For example, a spreading to the liver can cause abnormal blood tests, pain, and jaundice; a spreading to the bone can cause pain; and a spreading to the brain can cause confusion. Having a cancer may also change the body’s metabolism, causing symptoms such as weight loss, fever, sweats, and fatigue.
Ascites - The abnormal buildup of fluid in the abdominal cavity.
Pleural effusion - The abnormal buildup of fluid in the chest cavity.
What are the treatments for cancer?
We can treat cancer in a number of ways:
• By surgery, to remove the tumor, sometimes with surrounding tissue and local lymph nodes. Surgery can also be done to remove part of a tumor or to relieve symptoms caused by the tumor.
• By chemotherapy, treatments with drugs that destroy cancer cells or stop them from growing.
• By biologic therapy, treatments with immune substances that destroy cancer cells or strengthen the ability of the immune system to destroy cancer cells.
• By hormonal therapy, treatment that alters specific hormone levels in the body by stopping the production of the hormone, blocking the hormone, or adding hormone, thereby slowing or stopping the growth of cancer cells.
• By radiation therapy, the use of high-energy radiation to destroy cancer cells.
Surgery and radiation therapy are local treatments, directed to a particular part of the body. Chemotherapy, biologic therapy, and hormonal therapy are systemic treatments, which travel through the bloodstream to all parts of the body.
Cancer treatments are constantly evolving as doctors better understand the biology of how cancers start and grow and as they develop new ways to perform less invasive surgery and to more precisely deliver radiation therapy. For many cancers, doctors use combined modality therapy, that is, a combination of treatments. Oncologists, doctors who specialize in the treatment of cancer, can recommend the type of treatment that is best for you. The treatment depends on the type of cancer, the stage of disease, and your general state of health. Depending on your situation, the goal of the treatment may be to cure the disease, to control the growth of the cancer, or to relieve symptoms and improve quality of life (i.e., palliation).
Chemotherapy - Treatment with drugs that destroy cancer cells or stop them from growing.
Biologic therapy - Treatment with immune substances that destroy cancer cells or strengthen the ability of the immune system to destroy the cancer cells.
Hormonal therapy - Treatment that alters specific hormone levels in the body by stopping the production of the hormone, blocking the hormone, or adding hormone, thereby slowing or stopping the growth of the cancer cells.
Radiation therapy - The use of high-energy radiation to destroy cancer cells; also called radiotherapy.
For many cancers, doctors use combined modality therapy, that is, a combination of treatments.
Palliation - Treatment to relieve symptoms and to improve quality of life.
When is surgery used to treat cancer?
For many cancers, surgery is performed to remove the primary tumor. The local lymph nodes are often also removed for testing to determine whether the cancer has spread to the lymph nodes. If the tumor has invaded surrounding structures, they may be removed at the same time. For some patients with locally advanced disease, radiation therapy and/or chemotherapy are given before the surgery to shrink the tumor. This increases the chance that the entire tumor can be resected or removed. In some cases, it also allows for resection of the tumor without the need to remove surrounding structures. For example, this approach may be used with a cancer in the rectum, to avoid having to also remove the anus and create a permanent colostomy or opening in the skin for defecation.
Surgery can also be done to resect part of a tumor or to relieve symptoms that a tumor causes. Examples are surgery to remove a metastatic tumor in the brain, to bypass a blockage of the intestine, or to repair a bone broken from the spread of the cancer.
What is radiation therapy, and how is it given?
Radiation therapy treats disease with high-energy waves or particles. Radiation therapy is most commonly administered as external beam treatment. Beams of radiation are directed from a machine outside the body, markings, usually in the form of permanent tattoos the size of a pinhead. These devices and skin markings are used to position you correctly each day of treatment. While you are in the treatment position, radiologic images are taken to localize the area to be treated. Depending on the treatment planned, the images may be taken via X-rays, CTs, MRIs, and/or PETs.
After the simulation, the radiation oncologist (the doctor who prescribes radiation therapy), working with a physicist and dosimetrist (someone who calculates amounts of radiation), develops a treatment plan. This includes the dose of radiation to give, the number of radiation beams needed, at what angles they should be directed, and how they should be shaped.
Once the planning is completed, treatment begins. Treatment does not usually require hospitalization. It is given every day, Monday through Friday, until the total dose has been delivered-generally anywhere from 2 to 9 weeks. You are usually in the treatment room for 15 to 30 minutes each day. Radiation therapists set you up in the correct position and then leave the room. Using controls outside the room, they turn on the radiation beam, which stays on for about 5 to 15 minutes. When the beam is on, you feel nothing; there is no pain, burning, or discomfort. You may see the treatment machine move around you to the different positions needed to deliver each beam, and you hear the machine as it turns on and off. During treatment with external beam radiation therapy, your radiation oncologist and radiation oncology nurse see you weekly. They will evaluate how you are tolerating the treatment and help you manage any side effects you develop. We have made many advances in radiation therapy in recent years.
Technological advances in planning and delivering treatment are designed to direct the radiation beams more precisely, thereby reducing the doses received by the surrounding normal tissues. You might hear your doctor mention “three-dimensional conformal adiation therapy,” “intensity-modulated radiation therapy,” “image-guided radiation therapy,” or “stereotactic brain or body radiosurgery/radiotherapy.” New machines have also been developed to deliver treatment, for example, the TomoTherapy and CyberKnife systems and machines that deliver proton therapy.
Also, treatment schedules may vary. For instance, you may receive decreased doses given more than once a day or increased doses given in only one to five treatments. In addition, chemotherapy may be given with your radiation to enhance your response to treatment. Radiation therapy can also be administered by placing a radioactive source inside the body-an approach called internal radiation. One form of internal radiation is brachytherapy, radiation treatment that involves placing sealed radioactive sources (for example, seeds, wires, ribbons, or tubes) into the body.
These emit radiation into the immediately surrounding area as they decay (or break down). Depending on the type of source used, it may be kept in place for 15–20 minutes or for several days. Some sources are left in place permanently and are referred to as permanent seed implants; these implants decay and lose their energy over time, usually a number of months. Another form of internal radiation can be taken by mouth or injected into a vein (radiopharmaceutical therapy). This radioactive material travels through thebody and collects where tumor cells are located, emitting radiation until the body eliminates it.
Internal radiation may require hospitalization, and you might have to be isolated for a period of time because of the radiation your body is emitting. Your radiation oncologist and a physicist from the radiation safety service will advise you on the precautions you need to take. Here are some sources of information on radiation therapy:
• Radiation Therapy and You: A Guide to Self-Help During Cancer Treatment, published by the National Cancer Institute: www.cancer.gov
• American Society for Therapeutic Radiology and Oncology: www.rtanswers.org
• American College of Radiology: www.radiologyinfo.org
Brachytherapy - Radiation treatment that involves the placement of sealed radioactive sources (for example, seeds, wires, ribbons, or tubes) into the body that emit radiation into the immediately surrounding area as they decay (or break down); also called implant or internal radiation.
Radiation - therapy is carefully planned to ensure that an accurate dose is delivered to the tumor site while minimizing the dose received by the surrounding normal tissues.
(3) Why does cancer cause symptoms?
What is chemotherapy, and how is it given?
Chemotherapy is the treatment of cancer with drugs. Unlike surgery and radiotherapy, which are aimed at removing or killing cancers in localized parts of the body, chemotherapy is a systemic treatment. Chemotherapy travels throughout the body and can kill cancer cells anywhere in the body. Besides destroying cancer cells, chemotherapy can damage normal, healthy cells, especially healthy cells in the lining of the mouth and gastrointestinal tract, the bone marrow, and the hair follicles. Damage to healthy cells is why chemotherapy causes side effects. Healthy cells can usually repair themselves, and most side effects resolve after treatment.
There are more than 100 different types of cancer, and many different chemotherapy drugs are available. Your doctor will decide which chemotherapy drug(s) are right for you based on where your cancer started, on whether it has spread to other areas of your body, and on how healthy you are. For many types of cancer, your doctor will use a combination of drugs.
Chemotherapy can be given to cure the cancer, to control the disease, or to relieve symptoms (palliation). Neoadjuvant chemotherapy is chemotherapy treatment given before the primary treatment (such as surgery); it is used to shrink the tumor, making it easier for the surgeon to remove. Chemotherapy may also be given in this way before radiation therapy. Adjuvant chemotherapy is chemotherapy treatment used after a tumor has been removed surgically to destroy any microscopic cancer cells (those that cannot be seen with the naked eye) that may be left behind. For people with metastatic cancer, which usually cannot be cured, chemotherapy is the primary treatment, given to extend life and relieve symptoms.
Chemotherapy can be given in any form that other drugs are given, but it is most commonly given intravenously (IV), that is, through a thin needle inserted into a vein (the needle is taken out after the treatment is completed). Sometimes a special thin, flexible catheter is placed in a large vein in your body and left in place over a number of months or years, until it is no longer needed. The catheter is used for drawing blood and giving you chemotherapy, avoiding the need to stick a vein in your hand or arm. for more information about catheters.) Intravenous chemotherapy can be given over minutes (“IV push”), dripped in over a number of hours, or even infused continuously over a number of days. For some types of cancer, chemotherapy is given into an artery rather than a vein. (Arteries carry blood away from the heart; veins carry blood to the heart.) Chemotherapy can also be injected under the skin (subcutaneously), into the muscle, or into the cerebrospinal fluid. For some types of cancer, it is infused into a body cavity (e.g., the bladder or the abdomen).
For some types of skin cancer, chemotherapy can be applied as a cream or ointment directly to the skin. Increasingly, chemotherapy can be given orally (by mouth), in the form of a tablet, capsule, or liquid.
Patients commonly take oral chemotherapy at home. If you are responsible for administering your own chemotherapy, you must take it exactly as prescribed. If you are unable to do this, you need to notify your doctor immediately. Ask your doctor or nurse if you should follow any special instructions when handling chemotherapy at home.
Chemotherapy is given according to a schedule based on the type of cancer being treated and on the drugs being used. It may be given daily, weekly, every 2 to 3 weeks, or monthly. The schedule is often described as being in “cycles,” with treatment for a defined period followed by a rest to allow the normal tissues of the body to recover from the effects of the chemotherapy.
Chemotherapy may be given for a specific period of time (e.g., in six cycles) or indefinitely. Diagnostic tests are ordered periodically during chemotherapy treatment. Some tests evaluate how the tumor is responding; for example, a CT, MRI, or bone scan may be ordered every 3 to 6 months to see if the tumor has gotten smaller, remained stable, or grown. Other tests evaluate how the normal tissues in your body are responding, to ensure that the side effects of the treatment are not putting you at risk for further problems. For example, before each treatment, a complete blood count (CBC) may be ordered; this is a blood test to measure the number of white blood cells, red blood cells, and platelets. Its purpose is to check that your blood counts are not too low.
Blood chemistries may be ordered to make sure your kidneys and liver are functioning normally.
Neoadjuvant chemotherapy - Chemotherapy treatment given before the primary treatment (such as surgery) that is often used to shrink the tumor, making it easier for the surgeon to remove.
Adjuvant chemotherapy - Chemotherapy treatment and/or radiation therapy used after a tumor has been removed surgically to destroy any remaining microscopic cancer cells (those that cannot be seen with the naked eye) that may be left behind.
Complete blood count (CBC) - A blood test to measure the number of white blood cells, red blood cells, and platelets.
There are more than 100 different types of cancer, and many different chemotherapy drugs are available.
(4) Why does cancer cause symptoms?
What is targeted therapy?
Mary Ann’s comment:
I am presently receiving targeted therapy in a clinical trial. Three years ago, my right upper lobe was removed as it contained a malignant stage 1, no small cell tumor. I was fortunate in that there was no metastasis at that time, and, after careful consideration and several medical opinions, it was agreed that I did not need adjunct therapy of any kind.
I was free of cancer-or so I thought.
For 2 years I diligently had my
I began taking 50 mg daily of this trial drug. My skin became very dry and I had a great deal of trouble with my intestines. The dosage was lowered to 40 mg and my skin improved except for a yeast infection under my breasts.
This was handled with medication and flares occasionally. (I have to state that I’ve had this problem before I began the target medication as I am a large woman.) Eventually the dosage was moved to 30 mg, and I was given medication for my intestinal problems, which still persist. Around 5 months, I experienced some hair loss-ironically only the silver hair, and people thought I had colored my hair! I had a thick head of hair so most people don’t notice the loss-I have to admit I do and I never realized how vain I was about my hair. I have to remind myself how lucky I am to be experiencing such minor side effects.
Within 6 weeks of taking this trial medication, the small growth on the pancreatic tail was no longer visible (and later referred to as “calcified”). At the 6-month mark, the small tumors in my right lung also seem to have responded favorably and are no longer visible.
It is my understanding that I will take this medication for the rest of my life. Isn’t that a wonderful phrase, “the rest of my life”? Targeted therapy has given me hope that there is a long life ahead.
When treating cancers, doctors must now consider not only the origin of the cancer but also its biology. Recent laboratory research has helped us understand the complex biologic pathways in the cell that cause cancers to develop, grow, and spread. Targeted therapy works by blocking specific biologic pathways. There are several classes of targeted therapies; each blocks a specific pathway.
Here are examples from each class:
Tyrosine kinase inhibitors
Targeted therapy treatment affects only the cancer cells, having minimal effect on normal cells. As an example of how targeted therapies work, angiogenesis inhibitors block the formation of new blood vessels.
Cancer cells secrete proteins that promote the growth of new blood vessels, allowing the cells to multiply and spread. By blocking the formation of new tumor blood vessels, angiogenesis inhibitors prevent the cancer from growing, and the cancer cells are destroyed.
Targeted therapy works by blocking specific biologic pathways in the cell.
Targeted therapy treatment affects only the cancer cells, having minimal effect on normal cells.
What types of biologic therapies are used to treat cancer?
Biologic therapy, also called biotherapy or immunotherapy, includes a wide variety of approaches that use the immune system to treat cancer. The immune system consists of special cells and chemicals with the ability to recognize and destroy foreign or abnormal cells, including cancer cells. Biologic therapy introduces human-made immune substances into the body. These substances can destroy the cancer cells, make the cells more vulnerable to destruction by the body’s immune system, or strengthen the ability of the immune system to destroy the cancer cells. Most biologic therapies are still experimental.
• Monoclonal antibodies: These antibodies can recognize a specific abnormal protein on the surface of cancer cells, travel directly to these cells, and attack them. Examples of monoclonal antibodies used in cancer treatment are rituximab, trastuzumab, gemtuzumab, and alemtuzumab. These antibodies may be linked to chemotherapy or radioactive isotopes (unstable elements that emit radioactivity as they decay). The antibodies carry them to the site of cancer so the chemotherapy or radioactive isotopes can destroy the cancer cells. Because of their ability to differentiate between cancer cells and normal cells, monoclonal antibodies are a type of targeted therapy. An example of a monoclonal antibody linked to a radioactive isotope is ibritumomab tiuxetan.
• Cytokines: These chemicals can attack cancer cells or stimulate the immune system. Examples of cytokines used in cancer treatment are interferon, interleukin, and tumor necrosis factor.
• Vaccines: These are made from cancer cells that have been inactivated. Vaccines stimulate the immune system to make antibodies to destroy the cancer cells.
Radioactive isotopes - Unstable elements that emit radioactivity as they decay (break down); used to take diagnostic images or to treat cancer.
What types of hormonal therapies are used to treat cancer?
Hormones are chemicals produced by endocrine glands in the body. Cancer of the prostate and some cancers of the breast can be stimulated by specific hormones in the body. The hormones bind to receptors on the cancer cells’ surface and stimulate the cells to multiply, causing the cancer to grow. Hormonal therapies stop the body from producing the hormones or block their activity. The goal is to stop the cancer cells from dividing or to destroy them.
The male hormone testosterone, produced primarily by the testicles, stimulates prostate cancer to grow, and so hormonal therapy is one treatment for prostate cancer. Some medications, such as leuprolide and goserelin, stop the production of testosterone by the testicles. These medications, given by injection usually once a month or every 3 months, eliminate most of the testosterone in the body. Other medications given orally (e.g., flutamide, bicalutamide) may be given in addition to the injections to block the receptors on the prostate cancer cells, inactivating any remaining testosterone that is circulating.
Alternatively, the testicles may be surgically removed (orchiectomy) to prevent testosterone production, or the patient may be given female hormones (e.g., diethylstilbestrol) to counteract the effects of testosterone.
Side effects of long-term hormonal therapy in men with prostate cancer may include hot flashes, breast swelling and tenderness, decreased sex drive, inability to have an erection, loss of bone mass (osteoporosis), fatigue, and metabolic changes leading to weight gain
and an increased risk of diabetes and heart disease. The female hormone estrogen, produced primarily by the ovaries, stimulates some types of breast cancer to grow, and hormonal therapy is therefore one treatment for breast cancer. The medication that has been used the longest is tamoxifen, an oral medication that blocks the receptors on the breast cancer cells. Other similar oral medications are raloxifene and toremifene. Fulvestrant, given by injection once a month, not only blocks the receptors; it also destroys them. Even after menopause, a woman’s body produces a small amount of estrogen; agroup of drugs called aromatase inhibitors (e.g., anastrozole, letrozole, exemestane) blocks the enzyme that stimulates this.
Alternatively, women may receive leuprolide injections to stop the production of estrogen by the ovaries, have their ovaries surgically removed, or be given the hormone megestrol. Side effects of hormonal therapy in women with breast cancer may include hot flashes, vaginal discharge or irritation, fatigue, visual changes, and an increased risk of developing endometrial cancer or ovarian cysts.
(5) What are vascular access devices? Do I need one?
Receiving treatment for cancer often requires the nurse to frequently access your veins to draw blood, administer chemotherapy, or give intravenous fluids. The most common method is to insert a small metal or plastic needle under the skin into a vein in your hand or arm. Some people have veins that are difficult to find or that are very fragile, making visits to the doctor stressful because of worries that the nurse will not be able to get into the vein. In addition, some chemotherapy drugs are very irritating or must be given over many hours or days, with a risk that the drug can leak out of the vein and seep under your skin. To counteract these problems, special long-term vascular access devices have been developed to make it easier and safer for you to receive your treatment. These devices all have a special thin flexible catheter, or tube, that is placed under the skin and inserted into a large vein in your chest, leading to your heart. The catheter may be left in place for a number of months or years, until it is no longer needed.
In one type of device, the catheter is attached to an implantable port, a hollow round disk about the size of a quarter and a half-inch high. The disk is placed under the skin, usually on the chest wall, under the collarbone. To access the device, the nurse inserts a special needle through the skin into the port. Between treatments, the nurse must flush the device once a month to prevent it from clotting, but no other care is required. If you are “needle phobic,” ask your nurse about EMLA cream, which is a topical anesthetic. This medication can be applied to the skin directly over the port. The cream numbs the area, eliminating or reducing the pain of the needle stick. EMLA cream should be applied about 1 hour before your port is accessed. In another type of device, the catheter exits through the skin and is called an external catheter. Hickman catheters and PICC lines are examples of external catheters. The catheter may exit from the chest wall under the collarbone or on the arm. External catheters require frequent flushing and must be covered with a dressing. If you have an external catheter, your nurse will teach you how to take care of it. If you need a long-term catheter, your doctor will recommend the type that is best for you.
Long-term catheters can become infected and develop blood clots. Call your doctor immediately if you develop redness, swelling, discharge, or pain at the site of the port or where the catheter exits the skin, or if you develop swelling in the arm on the side of the catheter.
Topical anesthetic - A medication applied to the surface of the body (for example, the skin or mucous membranes) to numb the area.
Special long-term vascular access devices have been developed to make it easier and safer for you to receive your treatment
What are clinical trials?
I felt initially that one of the advantages of getting treatment at a cancer center was the potential of participating in a clinical research study. Every day you hear about new drugs that may have a positive effect on cancer, and I felt that participating in a trial was a good opportunity to take advantage of the newest scientific research. When my treatment options included a clinical trial, I didn’t hesitate to participate.
Mary Ann’s comment:
I am presently enrolled in a clinical trial-my diagnosis fourth stage lung cancer. I was taken by surprise when my lung cancer returned after 2 years. This time I went immediately to MSKCC [Memorial Sloan-Kettering Cancer Center] for treatment.
Fortunately, I had a consultation there after my initial surgery and in a study of my cancer cells, it appeared that I carried a mutated gene on my cancer cells. I was asked if I would consider being part of a clinical trial team that was treating this type of cancer.
Not without some trepidation-I feared being given a placebo, but with my family urging me to take part in this-I decided that it was worth a try. I was also assured that there were no “blind” studies and that no one in the study would be given a placebo. I was also assured that if there was no sign of improvement in 6 weeks, I would be taken out of the trial and put on a more conventional form of chemotherapy.
As part of the clinical trial, I am carefully monitored. For the first few months, I was tested every 2 weeks-blood, urine, scans, EKG, etc. Progress was swift for me and within 6 weeks, a tiny growth on the tail of my pancreas (which was an unusual form of the lung cancer metastasis) had calcified and was no longer an issue. I am just past 6 months in the trial, and the growths in my lungs seem to have also shrunk to nothing.
When I began this trial, I thought back to my days in kindergarten-I was one of the children given the Salk vaccine for polio in that “clinical trial.” Months later, we were notified that I had indeed received the live vaccine. I felt heroic as a child-and I feel heroic now. Regardless of how this turns out in the long run, I feel as though it gives my life purpose and if it doesn’t work for me, it may be the building block for someone else in the future. In one irony of this, the medication I am on has helped my arthritis and literally cured my diabetes. My blood sugar has been normal-with no medication-since the trial began.
Who knows what other benefits may come from this trial?
Clinical trials are research studies designed to test new treatments on humans. Any kind of treatment may be studied-methods of administering radiation therapy, drugs (including chemotherapy), biologic agents, nutritional therapies, medical devices, or even behavioral therapies. Either a single new treatment or standard treatments combined in new ways may be studied.
New treatments are usually first developed in a laboratory and then tested on animals. If they seem to provide some benefit, they are tested in phases on humans to determine their safety and effectiveness.
• Phase I clinical trials are undertaken first, to determine the appropriate dose and schedule for the treatment, as well as its side effects.
• Phase II clinical trials test the treatment on patients with a particular type of cancer to determine effectiveness.
• Phase III clinical trials are conducted on patients with a particular type of cancer to compare the effectiveness of the new treatment with that of the standard treatment. Half the patients in the study get the new treatment and half get the standard treatment. Patients enrolled in a Phase III clinical trial are randomly assigned to be in one of these groups. You cannot select the treatment you want.
Participating in a clinical trial is not being a “guinea pig.” The studies are designed thoughtfully and are based on information previously learned about the new treatment. To protect the safety of patients, the U.S. Food and Drug Administration (FDA) strictly regulates and monitors how clinical trials are conducted. The study must undergo internal review at the hospital the doctor is affiliated with, and it must be approved and monitored by an Institutional Review Board (IRB). In addition, for each study, very specific eligibility criteria describe who can be treated in the study; these criteria consist of a list of conditions that must be met for someone to enroll in a clinical trial. Finally, a clinical trial requires a consent form, a written document signed by patients to indicate that they have been informed about a treatment, as well as the associated risks and benefits, and that they agree to receive the treatment. The form describes the purpose of the study, the treatment the participants will receive, the possible side effects, the risks and benefits, and the financial costs. Before receiving any treatment, you must sign this consent form, indicating that you understand the study and you agree to participate in it.
Participating in a clinical trial gives you the opportunity to receive new treatments before they are available to other people. You receive care by a leading doctor affiliated with a major cancer center, and you are closely monitored throughout your treatment. You also contribute to progress in medical science. Just remember that the treatment given in a clinical trial is not yet proven to be more effective than the standard treatment you might otherwise receive, and you could even have unexpected side effects. Furthermore, you may have to spend more time receiving treatment, having the required diagnostic tests, and seeing the doctor. In addition, the financial cost to you may be greater. Your health insurance might not cover some aspects of the care, and you might have to pay for transportation or housing if the treatment is not close to home.
Although most cancer clinical trials are designed to test new treatments for cancer, an increasing number of trials are designed to test new methods of managing the symptoms experienced by people with cancer. If you are interested in finding out more about clinical trials, an excellent source of information is Taking Part in Clinical Trials: What Cancer Patients Need to Know, a booklet available from the Cancer Information Service of the National Cancer Institute.
Eligibility criteria - A list of conditions that must be met for someone to enroll in a clinical trial.
Consent form - A written document signed by patients to indicate that they have been informed about a treatment, as well as the associated risks and benefits, and that they agree to receive the treatment; also referred to as informed consent.
To protect patients, the U.S. Food and Drug Administration strictly regulates and monitors clinical trials.
What are complementary and alternative treatments?
Complementary and alternative medicine (CAM) includes a wide variety of approaches to improving health and treating disease that the traditional medical community does not recognize as standard or conventional. When used in addition to conventional methods of treatment, they are referred to as complementary; when used instead of conventional methods of treatment, they are referred to as alternative.
Complementary and alternative therapies may be categorized in many different ways.
The National Center for Complementary and Alternative Medicine (NCCAM) divides them into five domains:
1. Whole medical systems of theory and practice: These are practices used by different cultures in various parts of the world to stimulate or support the body’s ability to heal itself or restore the yin-yang balance and flow of qi. Examples include homeopathic medicine, naturopathic medicine, traditional Chinese medicine (e.g., acupuncture), and Ayurveda.
2. Mind–body medicine: These techniques help the mind enhance body functions and reduce symptoms. Examples include meditation, guided imagery, hypnosis, prayer, and creative therapies.
3. Biologically based practices: These use substances found in nature such as herbs, foods, vitamins, and other biologic products (e.g., shark cartilage).
4. Manipulative and body-based practices: These techniques involve the manipulation or movement of the body, such as those used by chiropractors and massage therapists.
5. Energy medicine: These techniques manipulate energy fields within or outside the body. Examples include therapeutic touch, the use of magnets, or Reiki (a technique of placing hands lightly on the body or just above it to heal the spirit and thus the body).
The practice of complementary and alternative therapies is rapidly increasing, partly due to our increasing understanding of them. The body of scientific knowledge about specific complementary and alternative therapies, how they work, and what effects they have on the body is constantly growing. To disseminate authoritative information about complementary and alternative therapies and to scientifically study their safety and effectiveness, the U.S. government founded the National Center for Complementary and Alternative Medicine as part of the National Institutes of Health.
However, the increased use of such therapies also reflects the desperation of many people with cancer, resulting in a willingness to try anything and everything they feel might help them. Complementary and alternative therapies are not regulated in the same way as traditional medications and medical devices. Many treatments and products offer no evidence of effectiveness, and, in fact, some may even be harmful to you. If you are considering unconventional therapies, get as much accurate information as you can about them. Discuss your thoughts with your doctor, and inform him or her of your intentions. Many of these therapies can be used safely with the traditional treatments you are receiving. Others, however, can interfere with your treatment, cause serious side effects when combined with your treatment, or may even be harmful to you.
Acupuncture - A technique of inserting thin needles into the body at specific locations with the goal of restoring the normal flow of energy in the body; often used to treat pain or other symptoms.
If you are considering unconventional therapies, get as much accurate information as you can about them, and speak with your doctor before you begin.
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