HCC 18-028 – Avmacol® Effects in Previously Treated Tobacco-Related Head and Neck Cancers

STUDY BASICS

Have you been successfully treated for a tobacco-related head and neck cancer in the past five years? If so, you may be able to participate in a research study to help learn more about the effects of a dietary supplement called Avmacol®. Avmacol is made up of broccoli seed, broccoli sprout extract, and vitamin C, and may help reduce inflammation and boost the immune system. Compensation provided.

STUDY PURPOSE

Head and neck cancers include cancers of the mouth, throat, voice box, nose, and sinus cavity. About 75% of head and neck cancers are caused by tobacco and alcohol use. With treatment, some head and neck cancers can be cured, but many people go on to develop a second head and neck cancer. The purpose of this study is to learn more about a dietary supplement called Avmacol in people who have been successfully treated for tobacco-related head and neck cancer. Avmacol, which is made up of broccoli seed, broccoli sprout extract, and vitamin C, may help protect against damage triggered by injury or inflammation. Researchers want to better understand how the body processes Avmacol, and learn more about the effect of Avmacol on inflammation and the immune system. Researchers hope their findings will lead to better ways to prevent the development of head and neck cancers in the future.

COULD THIS STUDY BE RIGHT FOR YOU?

• Ages 18 and up
• Diagnosed with tobacco-related head and neck cancer of the oral cavity (mouth, tongue, gums), pharynx (throat), or larynx (voice box) in the past five years
• Completed curative therapy 3 months to 5 years before study entry. Therapies may include surgery, radiation, and/or chemotherapy
• Current or former tobacco users
• Not pregnant

WHAT PARTICIPANTS CAN EXPECT

Participation includes 8-9 study visits over 4 months. Participants who are found to be eligible after an initial screening visit will be randomly assigned (like the flip of a coin) to receive one of two doses of Avmacol during the course of this study. Half of the study participants will take the lower dose (4 tablets) during the first month-long cycle and the higher dose (8 tablets) during the second month-long cycle; and half of the participants will take the higher dose first and the lower dose second. Researchers will study how Avmacol affects your body by collecting your cheek cells, urine, and blood. After you have taken your last dose of Avmacol, you will return one month later for an end-of-study visit.