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

GM-CSF Mouthwash for Preventing and Treating Mucositis in Patients Who Are Undergoing Radiation Therapy for Head and Neck Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by National Cancer Institute (NCI).   Recruitment status was  Recruiting

First Received on February 16, 2006.  
Last Updated on February 25, 2011  
History of Changes
Sponsor: University of California, San Francisco
Collaborator: 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: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Supportive Care
Official Title: Management of Mucositis With GM-CSF (Sargramostim) Mouthwash Study Protocol

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

  • Incidence of grade 1 or 2 oral mucositis by Radiation Therapy Oncology Group Acute Radiation Morbidity Scoring Criteria Oral Mucosa Assessment Scale at baseline, during radiotherapy, and once a month for 3 months after radiotherapy
  • Incidence of grade 3 or 4 oral mucositis by Radiation Therapy Oncology Group Acute Radiation Morbidity Scoring Criteria Oral Mucosa Assessment Scale at baseline, during radiotherapy, and once a month for 3 months after radiotherapy

Secondary Outcome Measures:

  • Quality of life at baseline, during radiotherapy, and once a month for 3 months after radiotherapy
  • Functional status by Karnofsky Performance Status Scale at baseline, during radiotherapy, and once a month for 3 months after radiation therapy
  • Severity and quality of pain by questionnaires at baseline, during radiotherapy, and once a month for 3 months after radiotherapy

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
Criteria

DISEASE CHARACTERISTICS:

  • Histopathologically confirmed diagnosis of head and neck cancer
  • Scheduled to undergo continuous course of conventional or hyperfractionated radiotherapy or intensity-modulated radiotherapy (IMRT) with or without concurrent chemotherapy
  • Planning to receive a total radiation dose ≥ 5,500 cGy, administered in a single daily fraction of 180-220 cGy (5 days a week) or twice daily fractions of 110-150 cGy
  • Normal baseline oral examinations (no pre-existing lesion)
  • No T1 or T2 glottic tumors

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 60-100%
  • Mentally capable of participating in research protocol
  • Expected survival > 4.5 months
  • No other serious concurrent medical illness
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Creatinine ≤ 2.0 mg/dL
  • Bilirubin ≤ 2.0 mg/dL
  • AST < 5 times upper limit of normal
  • HIV negative
  • No history of insulin-dependent diabetes mellitus
  • No prior hypersensitivity reaction to yeast material
  • No recent history of oral ulceration, herpes simplex, oral candidiasis, severe gingivitis, active or chronic mucositis, or xerostomia
  • No current New York Heart Association class II-IV congestive heart failure
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • No unresolved adverse event from previous therapy
  • No prior radiotherapy to the head and neck
  • No prior or concurrent brachytherapy
  • No prior participation in this study
  • No chemotherapy, radiotherapy, or other investigational drugs within the past 4 weeks
  • No major surgery within the past 2 weeks
  • No systemic sargramostim (GM-CSF) within the past 7 days
  • No systemic filgrastim (G-CSF) within the past 24 hours
  • No systemic long-acting pegfilgrastim within the past 14 days
  • No antibiotics, antifungals, or antivirals for oral conditions at baseline
  • No other concurrent chemotherapy agent
  • No concurrent enrollment on other head and neck studies
  • No other concurrent investigational drugs
  • No concurrent administration of any of the following:

    • "Magic or miracle mouthwash" containing a palliative mixture of topical anesthetics/analgesics, coating agents, and other medications without an approved indication for topical oral use except liquid antacid formulations (e.g., Maalox® or Mylanta® or their generic equivalents)
    • Other concurrent over-the-counter or prescription mouthwashes beyond the systematic oral care protocol provided by the study or any other drugs or agents to aid in oral hygiene (e.g., chlorhexidine, gluconate, pilocarpine, amifostine, sucralfate tablets or slurry, or benzydamine)
    • Use of corticosteroids for chronic conditions OR within the past 7 days
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00293462

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        
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Marylin J. Dodd, RN, PhD, FAAN University of California, San Francisco
  More Information

Additional Information:

No publications provided

Responsible Party: Marylin J. Dodd, University of California, San Francisco School of Nursing
ClinicalTrials.gov Identifier: NCT00293462    
History of Changes
Other Study ID Numbers: CDR0000459510, UCSF-H452-26184-03, FCCC-4626
Study First Received: February 16, 2006
Last Updated: February 25, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Head and Neck Neoplasms
Radiation Injuries
Mucositis
Neoplasms by Site
Neoplasms
Wounds and Injuries
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on August 21, 2012

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