Biafine Cream to Reduce Side Effects of Radiation Therapy in Patients Receiving Treatment for Advanced Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT00006481|
Recruitment Status : Completed
First Posted : December 31, 2003
Last Update Posted : November 19, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer Skin Reactions Secondary to Radiation Therapy||Drug: Biafine cream Procedure: quality-of-life assessment Radiation: radiation therapy||Phase 3|
OBJECTIVES: I. Compare the efficacy of prophylactic Biafine cream vs standard best supportive care in reducing grade 2 or higher radiation-induced skin toxicity observed during radiotherapy in patients with advanced squamous cell carcinoma of the head and neck. II. Determine if prophylactic or interventional use of Biafine cream is more effective based on a reduction in maximum skin toxicity resulting from radiation treatment in this patient population. III. Compare quality of life of these patients with this treatment. IV. Assess the toxicity of Biafine cream in these patients.
OUTLINE: This is a randomized study. Patients are stratified according to lymph node status (negative vs positive), type of treatment (radiation plus chemotherapy vs radiation alone), radiation fractionation (standard vs concurrent boost), and radiation dose (50-60 Gy vs greater than 60 Gy). Patients are randomized to 1 of 3 treatment arms. Arm I: Patients receive radiotherapy once daily 5 days a week for 5-8 weeks, with or without standard skin cream application (no Biafine cream) to irradiated skin. Arm II: Patients receive radiotherapy as in arm I, with Biafine cream applied to skin 3 times daily 7 days a week at the initiation of radiotherapy and continuing for 2 weeks after the last radiation treatment. Biafine cream is applied no fewer than 4 hours before treatment and no fewer than 4 hours between applications. Arm III: Patients receive radiotherapy as in arms I and II, with Biafine cream applied as in arm II only after skin becomes symptomatic (i.e., redness, dryness, itching, or tenderness). Quality of life is assessed before treatment, weekly during treatment, and then weekly for 4 weeks after treatment completion. Patients are followed weekly for 4 weeks.
PROJECTED ACCRUAL: Approximately 500 patients will be accrued for this study within 17 months.
|Study Type :||Interventional (Clinical Trial)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Phase III Comparison of Biafine to Declared Institutional Preference for Radiation Induced Skin Toxicity in Patients Undergoing Radiation Therapy for Advanced Squamous Cell Carcinomas of the Head and Neck|
|Study Start Date :||October 2000|
|Actual Primary Completion Date :||August 2002|
U.S. FDA Resources
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006481
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|Study Chair:||Elizabeth Elliott, MRT(T), MRT(R), CCRP||Margaret and Charles Juravinski Cancer Centre|