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GM-CSF Mouthwash for Preventing and Treating Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer

NCT00293462 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2021-07-30

Study results available
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Summary

GM-CSF may protect normal cells from the side effects, such as mucositis, of radiation therapy and may help damaged tissue heal faster after radiation therapy. This randomized clinical trial is studying how well GM-CSF works in preventing and treating mucositis in patients who are undergoing radiation therapy for head and neck cancer.

Conditions

Interventions

BIOLOGICAL

sargramostim

OTHER

oral salt and soda mouthwash

Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Marilyn Dodd

    lead OTHER

Principal Investigators

  • Marylin J. Dodd, RN, PhD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-07
Primary Completion
2009-12-31
Completion
2009-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00293462 on ClinicalTrials.gov