Testing the addition of the drug BMX-001, a radioprotector, or a placebo to the usual chemoradiation therapy for patients with head and neck cancer

People with head and neck cancer that will be receiving the usual treatment of cisplatin chemotherapy and radiation therapy may be eligible for the study.

This study is being done to answer the following question: Does giving BMX-001 during the usual treatment of cisplatin chemotherapy and radiation therapy result in less severe inflammation and mouth sores, a common side effect of cisplatin and radiation therapy that causes pain and difficulty swallowing? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your head and neck cancer. The usual approach is defined as the supportive care to manage side effects of chemotherapy and radiation most people get for head and neck cancer.

If you decide to take part in this study, you will either get the study drug BMX-001 or a placebo for up to 8 weeks during cisplatin and radiation therapy. You will also be asked to complete surveys 11 times during the study. You will continue to receive the usual symptom management for pain, swallowing discomfort, and side effect management.

The usual approach is defined as the supportive care most people get to treat the side effects of the radiation and cisplatin chemotherapy given for head and neck cancer. There are no standard methods or medicines for the prevention of mouth and throat inflammation, mouth sores and ulceration, and mouth and throat pain from cisplatin and radiation for head and neck cancer. Management of these side effects typically consists of using mouth rinses and pain medications during treatment and for several weeks after completion of treatment. Your study doctor will talk to you more about your cancer.

If you choose to take part in this study, there is a risk that the study approach may not be as good as the usual approach for your cancer. There is also a risk that you could have side effects from the study approach. Your doctor will review all of the potential side effects with you. There may be some risks that the study doctors do not yet know about.

There is evidence that this study drug is effective in reducing the side effects from the treatment in your type of cancer. It is not possible to know now if the study drug will reduce the side effects compared to the usual approach. This study will help the study doctors learn things that will help people in the future.

After you finish your study treatment, your doctor will continue to follow your symptoms for 2 years and watch you for side effects. They will check you when you finish treatment at 1, 3, 6, 12 and 24 months after treatment. This means you will keep seeing your doctor for 2 years after treatment.

No. Taking part in this study is voluntary. You are free to choose to participate or not to participate. If you choose to participate in this study, you are able to leave the study at any time. If you decide not to take part in this study, your doctor will discuss other treatment options with you.

You and/or your insurance plan will need to pay for the costs of medical care you get as part of the study, just as you would if you were getting the usual care for your cancer.

This includes:

• the costs of the usual cisplatin chemotherapy and radiation therapy to treat your cancer. 
• the costs of the tests, exams, procedures, and drugs that you get during the study to monitor your safety, and prevent and treat side effects. 
• the costs of usual symptom management to present and treat side effects. 
• the cost of getting the study drug BMX-001 or placebo ready and giving it you. 
• your insurance co-pays and deductibles.

Talk to your insurance provider and make sure that you understand what your insurance pays for and what it doesn’t pay for if you take part in this clinical trial. Also, find out if you need approval from your plan before you can take part in the study.

You will not be paid for taking part in this study.

Your privacy is very important to us and the researchers will make every effort to protect it. Your information may be given out if required by law. For example, certain states require doctors to report to health boards if they find a disease like tuberculosis. However, the researchers will do their best to make sure that any information that is released will not identify you. Some of your health information and/or information about your specimens from this study will be kept in a central database for research. Your name or contact information will not be put in the database.

There are organizations that may inspect your records. These organizations are required to make sure your information is kept private, unless required by law to provide information. Some of these organizations are:

• NRG Oncology, BioMimetix LLC, and any company supporting the study now or in the future. This would include any organization helping the company with the study. 
• The National Cancer Institute (NCI) Central Investigational Review Board (IRB), which is a group of people who review the research with the goal of protecting the people who take part in the study. 
• The Food and Drug Administration (FDA) and the groups it works with to review research. 
• The NCI and the groups it works with to review research, including the Cancer Trials Support Unit (CTSU). 
• The NCI’s National Clinical Trials Network and the groups it works with to conduct research including the Imaging and Radiation Oncology Core (IROC). 
• VisionTree, Inc. (if you consent to completing questionnaires electronically your responses to questionnaires will be collected).

Doctors and researchers conduct a clinical study, also called a “clinical trial,” to find better ways to prevent, diagnose, or treat an illness. NRG Oncology is supported by the National Cancer Institute (NCI) and runs clinical studies specifically for patients with cancer or to prevent cancer. Most clinical studies test something we know against something we don’t know. In all situations, these studies are strictly evaluated before they are allowed to be offered to any patient. The study is designed to answer the question that we do not know the answer to, so that current and future patients may have better treatments or information than what we currently have. There are different types of clinical studies that might be available for patients. For more information see “Types of Clinical Trials” and “Phases of Clinical Trials”.

Patients who volunteer to take part in a clinical study are followed closely by their health care professionals and members of the research team. For more information see “Research Team Members”.

Yes. They are exactly the same thing.

The care cancer doctors provide to cancer patients today is the direct result of clinical studies (also known as clinical trials) that were done in the past. Clinical studies give doctors and the treatment team information about what types of treatments work and what treatments do not work, in a number of different situations. Some studies focus on treating the cancer, others on preventing the cancer, and others on helping patients feel better or healthier during or after treatments. When you take part in a clinical study, you add to our knowledge about cancer and it may help improve cancer care for future patients. Clinical studies are available to patients with many types of cancer and at all stages of treatment. In some situations, the only way to get these new treatments is by joining a clinical study.

A clinical study may take place in many locations, such as:

physician offices

hospitals

clinics

A study is typically led by a principal investigator who is a doctor or other advanced health care professional. A clinical study is carried out by following a very specific plan known as the “protocol”. The protocol is designed so all patients in the study are treated as well as possible and in the same way. The protocol also provides rules for the doctors and clinical study staff to follow to keep patients safe and make sure the study is run in an ethical manner.

No, not at all. Participation in a clinical study is completely voluntary. For more information see “Deciding to Take Part in a Clinical Trial”. You are free to choose to participate or not to participate. If you choose to participate in a study, you may still decide to leave the study at any time. If you decide not to participate in a study, your doctor will discuss other treatment options with you. For more information see “Questions to Ask Your Doctor about Treatment Clinical Trials".

• You may choose to have the usual treatment approach (known as “standard of care”)
• You may choose to take part or learn more about a different study, if one is available
• You may choose not to be treated for cancer