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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00006481
First received: November 6, 2000
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Head and Neck Cancer
Skin Reactions Secondary to Radiation Therapy
Drug: Biafine cream
Procedure: quality-of-life assessment
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Study Start Date: October 2000
Primary Completion Date: August 2002 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV squamous cell carcinoma of the head and neck, including: Oral cavity Oropharyngeal Hypopharyngeal Laryngeal Radiotherapy indicated as primary treatment or treatment after primary surgical resection Primary field to receive at least 50 Gy No skin rash, ulceration, or open wound in treatment field No tumor involvement of the skin

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Zubrod 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No known skin allergy or sensitivity to Biafine No inflammatory or connective tissue disorders of the skin No history of mental incompetence, including psychological disorders or drug dependency disorders, that would preclude study compliance

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Concurrent chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy to treatment field Surgery: See Disease Characteristics Prior surgery allowed Other: No other concurrent investigational therapy No concurrent participation on other RTOG clinical trials No concurrent amifostine (concurrent pilocarpine allowed)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006481

  Show 260 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: Elizabeth Elliott, MRT(T), MRT(R), CCRP Margaret and Charles Juravinski Cancer Centre
  More Information

Additional Information:
Publications:
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00006481     History of Changes
Other Study ID Numbers: RTOG-9913, CDR0000068312, RTOG-DEV-1073, NCI-P00-0173
Study First Received: November 6, 2000
Last Updated: November 18, 2013
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
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

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell

ClinicalTrials.gov processed this record on November 24, 2014