Join Clinical Trials for Oral Cancer
Oral cancer is often described collectively with other cancers that occur in the head and neck as simply “head and neck cancer.” However, literally speaking, cancers that arise in the mouth can affect the lips, tongue, cheek lining, floor of the mouth, gums, or palate (roof of the mouth).
Unfortunately, the majority of oral cancers spread quickly and therefore require immediate treatment. Most are also linked to the use of alcohol and tobacco; however, additional risk factors include chronic irritation from things such as dentures or fillings, human papillomavirus (HPV) infection, the use of immunosuppressant medications, and poor oral hygiene practices.
The good news is that if detected early before they have spread, oral cancers have nearly a 90% cure rate; the bad news is that over half of all oral cancers have usually spread by the time the cancer is diagnosed. As such, approximately 25% of patients die as a result of delayed diagnosis and treatment.
For those reasons, researchers are hard at work to identify new and improved methods of screening and diagnosis for oral cancer among high-risk patients, as well as refining existing treatments and developing new ones with the intent of improving treatment-related outcomes and life expectancy.
In addition, a considerable amount of research is underway to develop strategies that more effectively minimize and prevent the numerous complications associated with treatment for oral cancer (including those associated with radiation therapy, disfigurement, and quality of life concerns).
What Will Oral Cancer Clinical Trials Be Like?
Clinical trials for oral cancer 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 oral cancer include the following:
- Physical exam and detailed history of tobacco and alcohol use.
- Blood and/or tissue sample to test for the presence of HPV infection.
- 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.
- Detailed examination of the mouth and tongue.
- Imaging procedures such as 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. Conventional x-rays may also be used.
- Quality of life assessments to evaluate how your cancer is impacting your ability to perform activities of daily living.
- Pain assessments.
- Dietary assessments.
Typical Oral Cancer Clinical Trial Protocol:
Examples of sample clinical trials in oral cancer might include the following:
- A clinical trial to determine if patients’ HPV status has an impact on their survival following treatment for oral cancer.
- A clinical trial to determine if an innovative dosing schedule for radiation therapy is more effective at treating lip cancer than a conventional dosing schedule for radiation therapy.
- A study to determine if the use of a salivation-boosting drug is effective at decreasing the rate of dry mouth in tongue cancer patients following radiation therapy, compared to the rate of dry mouth among tongue cancer patients who receive radiation therapy in addition to a placebo.
- A study to determine if treatment with a newly developed drug is effective at reducing the incidence of oral cancer among individuals with high-risk pre-cancerous mouth lesions.
- A long-term clinical trial to determine if specific dietary supplements or medications are effective at reducing the risk of oral cancer in high-risk individuals who smoke and drink alcohol.
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 third 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:
The following search terms may be useful when added to the keywords “oral cancer”: “prevention,” “treatment,” “surgery,” “chemotherapy,” “radiation therapy,” “treatment side effects,” “HPV,” “human papillomavirus,” “nutrition,” “pain,” “quality of life,” “screening,” “smoking,” and “alcohol.”
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