Join Clinical Trials for Ovarian Cancer
The ovaries are almond-sized organs that are part of a female’s reproductive system. They release eggs for the purposes of reproduction, and are also responsible for the production of two key hormones – estrogen and progesterone. Like all other parts of the body, the ovaries can also be affected by cancer.
It is estimated that in 2012, over 22,000 new cases of ovarian cancer will be diagnosed and over 15,000 deaths due to ovarian cancer will occur. Ovarian cancer is more common among women with a family history of the disease, those who are over the age of 55, and those who have a personal history of cancer (especially cancer of the breast, uterus, colon, or rectum).
In addition, women who have never been pregnant, as well as women who have a history of hormone therapy, are also at an increased risk of ovarian cancer. Some symptoms of ovarian cancer include abdominal pressure or pain, as well as pain in the pelvis, back or legs. Abdominal swelling may also occur, as well as nausea, indigestion, constipation, or diarrhea. Ovarian cancer may also result in extreme fatigue.
Unfortunately, ovarian cancers are often diagnosed when they are in the later stages of development, due to their non-specific symptoms and the fact that they can grow for some time before symptoms ever become noticeable. Ovarian cancers are usually treated with a combination of surgery and chemotherapy; radiation therapy is not routinely used.
Ovarian cancer research is currently focused on a number of aspects related to the disease. Research into the genetic causes of ovarian cancer is gaining speed, as scientists look to gain a better understanding of how various genes involved with ovarian cancer lead to its development.
The information gained from such studies is helping to fuel additional studies that seek to develop better methods for screening women who are at an increased risk of developing ovarian cancer due to their family history or certain genetic factors. Relatedly, some studies are testing new drugs to see if they can help prevent ovarian cancer from occurring among high-risk women.
Finally, new treatments are constantly being tested, including new combinations of chemotherapy designed for women whose cancers have become resistant to the effects of standard chemotherapy drugs.
What Will Ovarian Cancer Clinical Trials Be Like?
Ovarian cancer clinical trials may involve many common tests and procedures; however, the ultimate design of the particular study will determine which specific procedures you will undergo. Examples of specific tests and procedures that may be used in a clinical trial for ovarian cancer include the following:
- Physical exam and detailed family history information
- Pelvic exam
- Pap smear
- Blood and/or tissue sample for the purposes of conducting genetic testing
- If the study is evaluating a new type of medication or vaccine, blood and/or urine tests may be performed to monitor how your body metabolizes the medication or how effectively your body has responded to the vaccine.
- Imaging procedures such computed tomography (CT scan, or “CAT scan”) or magnetic resonance imaging (MRI) scans. These imaging procedures are non-invasive and provide detailed pictures of areas inside your body.
- Colonoscopy: a procedure during which a thin, flexible tube with a tiny light and camera attached to the end is inserted through the rectum into the intestines. This test can help to identify if ovarian cancer has spread to the colon and/or rectum.
- Chest x-ray to identify lung metastases
- Abdominal or vaginal ultrasound
- Quality of life assessments to evaluate how your cancer is impacting your ability to perform activities of daily living.
- Pain assessments
Typical Ovarian Cancer Clinical Trial Protocol:
There is a variety of research currently being conducted for women with ovarian cancer. Sample clinical trials might include the following:
- A clinical trial in which patients with ovarian cancer are randomly assigned to receive standard chemotherapy combined with a newly-developed immunotherapy drug (a drug that works with the body’s natural immune system to attack cancer cells) or standard chemotherapy plus a placebo.
- A clinical trial to determine the effectiveness of an ovarian cancer vaccine in healthy women with a family history of ovarian cancer and a specific genetic mutation known to be associated with an increased risk of ovarian cancer.
- A clinical trial designed to evaluate if long-term use of hormonal contraceptives (e.g., birth control pills) is associated with an increased risk of ovarian cancer.
- A study to evaluate genetic mutations in ovarian cancers and determine if the presence of certain mutations indicate a more favorable response to a particular chemotherapy drug.
- A study to determine which type of surgical method used to remove the ovaries and fallopian tubes leads to the fewest side effects for patients.
A brief word about randomized trials and placebos:
Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.
On occasion, a trial will investigate the use of a standard treatment plus a new drug compared to standard treatment plus a placebo (such as the first clinical trial example provided above). Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.
Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.
In rare instances where no standard therapy exists, or when a new drug is being evaluated for the first time in a specific cancer, the investigational treatment might be compared to a placebo alone. In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.
This is rarely done in cancer clinical trials; however, it may occasionally be necessary from a scientific standpoint. Placebo-only trials will only be done when ethically appropriate and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment.
It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular type of cancer and clinical situation.
Trial Eligibility and Medical Information Needed:
The type of clinical trial you may be eligible for often depends on many factors, including your disease stage, treatment history, and a variety of clinical findings. Therefore, it is important to know many details pertaining to your specific diagnosis when searching for clinical trials. Examples of the details you will want to have on hand include:
- The name, location, size, stage, and cell type of your cancer, as well as the locations of any metastases you have. Also know these details for any prior cancer you have had.
- Know your performance status, which estimates how well you perform normal activities of daily living. Examples: Karnofsky Performance Scale (KPS) and the ECOG scale.
- Know your treatment history, including chemotherapy, radiation therapy, immunotherapy, and/or surgery.
- Know your blood cell counts, liver function test results, and kidney function test results.
Suggested Search Terms:
“ovarian cancer treatment,” “ovarian cancer chemotherapy,” “ovarian cancer management,” “ovarian cancer surgery,” “advanced ovarian cancer,” “ovarian cancer vaccine,” “ovarian cancer screening,” “ovarian cancer pediatric,” and “ovarian cancer genetics.”
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