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| Sponsors and Collaborators: |
University of California, San Francisco National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00293462 |
Purpose
RATIONALE: 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.
PURPOSE: 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.
| Condition | Intervention |
|
Head and Neck Cancer Oral Complications of Chemotherapy and Head/Neck Radiation Radiation Toxicity |
Drug: sargramostim |
| MedlinePlus related topics: | Cancer Head and Neck Cancer Tonsils and Adenoids |
| ChemIDplus related topics: | Sargramostim Granulocyte-macrophage colony-stimulating factor Salicylsalicylic acid Sodium salicylate |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Double-Blind, Active Control |
| Official Title: | Management of Mucositis With GM-CSF (Sargramostim) Mouthwash Study Protocol |
| Estimated Enrollment: | 222 |
| Study Start Date: | December 2004 |
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No concurrent administration of any of the following:
Contacts and Locations| United States, California | |||||
| University of California, San Francisco School of Nursing | Recruiting | ||||
| San Francisco, California, United States, 94115 | |||||
| Contact: Marylin J. Dodd, RN, PhD, FAAN 415-476-4320 | |||||
| University of California, San Francisco |
| National Cancer Institute (NCI) |
| Principal Investigator: | Marylin J. Dodd, RN, PhD, FAAN | University of California, San Francisco |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
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| Study ID Numbers: | CDR0000459510, UCSF-H452-26184-03, FCCC-4626 |
| First Received: | February 16, 2006 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00293462 |
| Health Authority: | Unspecified |
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