Biafine Cream to Reduce Side Effects of Radiation Therapy in Patients Receiving Treatment for Advanced Head and Neck Cancer
Condition: Head and Neck Cancer; Skin Reactions Secondary to Radiation Therapy
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      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.
    

Intervention name(s): Biafine cream; quality-of-life assessment; radiation therapy
Intervention type(s): Drug; Procedure; Radiation
Primary purpose: Supportive Care
Keywords: stage III squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the larynx; skin reactions secondary to radiation therapy