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

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), October 2007

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   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care, Randomized, Double-Blind, Active Control
Official Title:   Management of Mucositis With GM-CSF (Sargramostim) Mouthwash Study Protocol

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  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
National Cancer Institute (NCI)

Investigators
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  This link exits the ClinicalTrials.gov site
 

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

Keywords provided by National Cancer Institute (NCI):
oral complications of chemotherapy and head/neck radiation  
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

Study placed in the following topic categories:
Mucositis
Squamous cell carcinoma
Salicylsalicylic acid
Sodium Salicylate
Carcinoma, Basal Cell
Granuloma
Adenoid cystic carcinoma
Recurrence
Carcinoma
Epidermoid carcinoma
Nasopharyngeal carcinoma
Carcinoma, Adenoid Cystic
Metastatic squamous neck cancer with occult primary
Head and Neck Neoplasms
Carcinoma, squamous cell
Laryngeal carcinoma
Hypopharyngeal cancer
Carcinoma, Squamous Cell
Papilloma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 10, 2008




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