Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 3

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

NCT00006481 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • PROCEDURE quality-of-life assessment
  • RADIATION radiation therapy
  • DRUG Biafine cream

Study Locations (20)

California

  • Mount Diablo Medical Center — Concord
  • Cancer Center and Beckman Research Institute, City of Hope — Duarte
  • California Cancer Center — Fresno
  • Saint Agnes Cancer Center — Fresno
  • Glendale Memorial Hospital and Health Center — Glendale
  • Sutter Health West Cancer Research Group — Greenbrae
  • University of California San Diego Cancer Center — La Jolla
  • Loma Linda University Medical Center — Loma Linda
  • Veterans Affairs Medical Center - Long Beach — Long Beach
  • USC/Norris Comprehensive Cancer Center and Hospital — Los Angeles

Alabama

  • University of Alabama at Birmingham Comprehensive Cancer Center — Birmingham
  • Huntsville Hospital System — Huntsville
  • Comprehensive Cancer Institute of Huntsville — Huntsville
  • MBCCOP - Gulf Coast — Mobile
  • Alabama Oncology, LLC — Montgomery
  • Radiation Oncology Associates of West Alabama — Tuscaloosa

Arizona

  • Foundation for Cancer Research and Education — Phoenix
  • Arizona Cancer Center — Tucson

Alaska

  • Providence Alaska Medical Center — Anchorage

Arkansas

  • University of Arkansas for Medical Sciences — Little Rock

Trial Details

FieldValue
Start Date 2000-10
Phase Phase 3

Sponsor

Radiation Therapy Oncology Group

37 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00006481

The ClinicalTrials.gov registry entry for NCT00006481 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is Radiation Therapy Oncology Group, which has 37 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 3 interventions — of which quality-of-life assessment is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00006481 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Alabama, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00006481 about?

NCT00006481 is a clinical study titled "Biafine Cream to Reduce Side Effects of Radiation Therapy in Patients Receiving Treatment for Advanced Head and Neck Cancer". 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 re...

What is the current status of trial NCT00006481?

This trial is currently completed. It is a Phase 3 study. The study started on 2000-10.

What conditions does trial NCT00006481 study?

This clinical trial studies the following conditions: Head and Neck Cancer, Skin Reactions Secondary to Radiation Therapy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00006481?

The interventions under investigation include: quality-of-life assessment (PROCEDURE), radiation therapy (RADIATION), Biafine cream (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00006481?

This trial is sponsored by Radiation Therapy Oncology Group, which has 37 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00006481 being conducted?

This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial