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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 Mucositis Radiation Toxicity |
Biological: sargramostim |
| 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 |
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 | |
| Principal Investigator: | Marylin J. Dodd, RN, PhD, FAAN | University of California, San Francisco |
More Information
| Study ID Numbers: | CDR0000459510, UCSF-H452-26184-03, FCCC-4626 |
| Study First Received: | February 16, 2006 |
| Last Updated: | May 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00293462 History of Changes |
| Health Authority: | Unspecified |
|
mucositis radiation toxicity recurrent squamous cell carcinoma of the hypopharynx stage I squamous cell carcinoma of the hypopharynx stage II squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the larynx stage I squamous cell carcinoma of the larynx stage II squamous cell carcinoma of the larynx stage III squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the larynx recurrent basal cell carcinoma of the lip stage I basal cell carcinoma of the lip stage II basal cell carcinoma of the lip |
stage III basal cell carcinoma of the lip stage IV basal cell carcinoma of the lip recurrent squamous cell carcinoma of the nasopharynx stage I squamous cell carcinoma of the nasopharynx stage II squamous cell carcinoma of the nasopharynx stage III squamous cell carcinoma of the nasopharynx stage IV squamous cell carcinoma of the nasopharynx recurrent squamous cell carcinoma of the oropharynx stage I squamous cell carcinoma of the oropharynx stage II squamous cell carcinoma of the oropharynx stage III squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity stage I squamous cell carcinoma of the paranasal sinus and nasal cavity stage II squamous cell carcinoma of the paranasal sinus and nasal cavity |
|
Mouth Diseases Nasopharyngeal Carcinoma Mucositis Laryngeal Carcinoma Gastrointestinal Diseases Carcinoma, Basal Cell Squamous Cell Carcinoma Granuloma Recurrence Hypopharyngeal Cancer Carcinoma |
Digestive System Diseases Metastatic Squamous Neck Cancer With Occult Primary Carcinoma, Adenoid Cystic Head and Neck Neoplasms Epidermoid Carcinoma Adenoid Cystic Carcinoma Stomatognathic Diseases Carcinoma, Squamous Cell Papilloma Gastroenteritis |
|
Mouth Diseases Neoplasms Digestive System Diseases Neoplasms by Site Mucositis |
Gastrointestinal Diseases Head and Neck Neoplasms Stomatognathic Diseases Gastroenteritis |