Biafine Cream to Reduce Side Effects of Radiation Therapy in Patients Receiving Treatment for Advanced Head and Neck Cancer

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells, but may cause skin irritation and inflammation. Biafine cream may be effective in lessening side effects caused by radiation therapy. PURPOSE: Randomized phase III trial to determine the effectiveness of Biafine cream in reducing side effects of radiation therapy in patients receiving treatment for head and neck cancer.

Timeline

Start

2000-10

Primary completion

2002-08

Completion

—

Outcome

Missed primary endpoint

paper The results of this trial demonstrate no advantage for the use of trolamine in reducing the incidence of grade 2 or higher radiation dermatitis PMID 16648511 ↗

Publications

• Results Elliott EA, Wright JR, Swann RS, Nguyen-Tan F, Takita C, Bucci MK, Garden AS, Kim H, Hug EB, Ryu J, Greenberg M, Saxton JP, Ang K, Berk L; Radiation Therapy Oncology Group Trial 99-13. Phase III Trial of an emulsion containing trolamine for the prevention of radiation dermatitis in patients with advanced squamous cell carcinoma of the head and neck: results of Radiation Therapy Oncology Group Trial 99-13. J Clin Oncol. 2006 May 1;24(13):2092-7. doi: 10.1200/JCO.2005.04.9148.

Drugs

Indications