JACKSONVILLE, Fla. -- "Magic mouthwash," an oral rinse containing diphenhydramine, lidocaine and antacids, significantly reduced pain from oral mucositis, mouth sores, in patients receiving radiation therapy for cancers of the head and neck when compared to plaecbo. These were the findings of a multi-institution, randomized, double-blind, placebo-controlled, phase III clinical trial, led by Robert Miller, M.D., an emeritus Mayo Clinic radiation oncologist. Dr. Miller and his colleagues published their findings on Tuesday, April 16, in JAMA.
"Our group published a study in 2012 showing that an oral rinse of doxepin reduced oral mucositis-related pain, compared to placebo," says Dr. Miller. "However, there were no large randomized controlled trials studying the potential benefits of magic mouthwash."
Dr. Miller and his colleagues studied 275 patients between November 2014 and May 2016. They found that pain related to oral mucositis was significantly less following both doxepin and magic mouthwash rinses versus placebo. They also found that both doxepin and magic mouthwash rinses were well-tolerated by patients.
"Radiation therapy may cause mouth sores because it is designed to kill rapidly growing cells, such as cancer cells," says co-author, Terence Sio, M.D., a Mayo Clinic radiation oncologist in Arizona. "Unfortunately, healthy cells in your mouth also divide and grow rapidly, and may be damaged during radiation therapy, which can cause discomfort. We're glad to have identified a proven method to help treat the discomfort of this side effect."
Research was conducted through the Alliance for Clinical Trials in Oncology and included investigators from these institutions:
- Mayo Clinic's campuses in Arizona, Florida and Minnesota
- Wichita Community Oncology Research Program, Wichita, Kansas
- Southeast Clinical Oncology Research Consortium Community Oncology Research Program, Spartanburg, South Carolina
- Roswell Park Comprehensive Cancer Center, Buffalo, New York
- The Ohio State University Wexner Medical Center, Columbus, Ohio
About the Alliance
The Alliance for Clinical Trials in Oncology develops and conducts clinical trials with promising new cancer therapies, uses the best science to develop optimal treatment and prevention strategies for cancer and researches methods to alleviate side effects of cancer and cancer treatments. The Alliance has been awarded a grant by the National Cancer Institute as a member of the National Cancer Institute National Clinical Trials Network in addition to a grant to serve as a research base for the National Cancer Institute Community Oncology Research Program. The alliance comprises nearly 10,000 cancer specialists at hospitals, medical centers and community clinics across the U.S. and Canada. Learn more about the alliance.
About Mayo Clinic Cancer Center
As a leading institution funded by the National Cancer Institute, Mayo Clinic Cancer Center conducts basic, clinical and population science research, translating discoveries into improved methods for prevention, diagnosis, prognosis and therapy. For information on cancer clinical trials, call the Clinical Trials Referral Office at 1-855-776-0015 (toll-free).
About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to clinical practice, education and research, providing expert, comprehensive care to everyone who needs healing. Learn more about Mayo Clinic. Visit the Mayo Clinic News Network.