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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00293462
First received: February 16, 2006
Last updated: May 14, 2013
Last verified: May 2013
  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
Other: oral salt and soda mouthwash

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
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 University of California, San Francisco:

Primary Outcome Measures:
  • Prevention Phase (Prior to Onset of Mucositis): Compare GG and SS Prior to Onset of Mucositis to Evaluate the Incidence of Radiation Therapy-induced Oral Mucositis [ Time Frame: Prevention Phase (prior to onset of mucositis): Baseline to onset of mucositis. Actual time variable, mean time: 16.18 days (SD 7.4) ] [ Designated as safety issue: No ]
    Incidence of grade 1 or 2 oral mucositis by Radiation Therapy Oncology Group Acute Radiation Morbidity Scoring Criteria Oral Mucosa Assessment Scale at baseline and during radiotherapy.

  • Treatment Phase (Begins at Onset of Mucositis): Comparison of Three Groups to Evaluate the Effectiveness of the Two Mouthwashes. [ Time Frame: From onset of mucositis to healing of mucositis. Actual time variable. Mean: 95.8 days (SD 46.8) ] [ Designated as safety issue: No ]
    To evaluate the effectiveness of the two mouthwashes in treating oral mucositis as defined by the incidence of Radiation Therapy Oncology Group Acute Radiation Morbidity Scoring. The number of days for mucositis to heal.


Secondary Outcome Measures:
  • Quality of Life During Radiation Therapy [ Time Frame: at baseline, during radiation therapy, and once a month for 3 months after radiation therapy ] [ Designated as safety issue: No ]
    Quality of life at baseline, during radiotherapy, and once a month for 3 months after radiotherapy. Quality of Life is measured with a scale that ranges from 0-10 with higher scores indicating a better quality of life. Scores at all time points were combined to compute one mean.

  • Functional Status by Karnofsky Performance Status Scale [ Time Frame: baseline through 3 months ] [ Designated as safety issue: No ]
    Functional status by Karnofsky Performance Status Scale (0-100 with higher scores indicating better functional status) at baseline, during radiotherapy, and once a month for 3 months after radiation therapy. Scores at all time points were combined to compute one mean.

  • Pain Questionnaire [ Time Frame: baseline through 3 months ] [ Designated as safety issue: No ]
    Severity and quality of pain by questionnaires (0-10 with higher scores indicating more pain) at baseline, during radiotherapy, and once a month for 3 months after radiotherapy. Scores at all time points were averages together to compute one mean.


Enrollment: 91
Study Start Date: May 2005
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I: GM-CSF Group (GG)
Arm I: Patients were randomized to receive oral sargramostim (GM-CSF) mouthwash as a prevention, holding it in their mouths and swallowing it in intervals over 1 hour once daily. If they develop mucositis, they continue receiving GM-CSF treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
Biological: sargramostim
Active Comparator: Arm II: Salt & Soda Group (SS)
Arm II: Patients were randomized to receive salt and soda (SS) mouthwash as a prevention, holding it in their mouths and swallowing it in intervals over 1 hour once daily. If they develop mucositis, they continue receiving SS treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
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.
Active Comparator: Arm III: Salt & Soda Switched to GM-CSF (SG)
Arm III: Patients were randomized to receive oral salt and soda (SS) mouthwash as a prevention, holding it in their mouths and swallowing it in intervals over 1 hour once daily. If they develop mucositis, they continue receiving GM-CSF treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
University of California, San Francisco School of Nursing
San Francisco, California, United States, 94115
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: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00293462     History of Changes
Other Study ID Numbers: CDR0000459510, UCSF-H452-26184-03, FCCC-4626
Study First Received: February 16, 2006
Results First Received: March 27, 2013
Last Updated: May 14, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
mucositis
radiation toxicity
recurrent squamous and basal cell carcinoma of the hypopharynx,larynx,lip,nasopharynx
oropharynx, paranasal sinus and nasal cavity
stage I-IV lymphoepithelioma of the nasopharynx
stage I-IV lymphoepithelioma of the oropharynx
Recurrent and stage I-IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
Recurrent and stage I-IV inverted papilloma of the paranasal sinus and nasal cavity
Recurrent and stage I-IV midline lethal granuloma of the paranasal sinus and nasal cavity
untreated, current,metastatic squamous neck cancer with occult primary
recurrent verrucous carcinoma of the larynx
recurrent lymphoepithelioma of the oropharynx
stage I verrucous carcinoma of the larynx
recurrent verrucous carcinoma of the oral cavity
stage I verrucous carcinoma of the oral cavity
stage II verrucous carcinoma of the larynx
stage II verrucous carcinoma of the oral cavity
stage III verrucous carcinoma of the larynx
stage III verrucous carcinoma of the oral cavity
stage IV verrucous carcinoma of the larynx
stage IV verrucous carcinoma of the oral cavity
recurrent adenoid cystic carcinoma of the oral cavity
stage I adenoid cystic carcinoma of the oral cavity
stage II adenoid cystic carcinoma of the oral cavity
stage III adenoid cystic carcinoma of the oral cavity
stage IV adenoid cystic carcinoma of the oral cavity
recurrent mucoepidermoid carcinoma of the oral cavity
stage I mucoepidermoid carcinoma of the oral cavity
stage II mucoepidermoid carcinoma of the oral cavity
stage III mucoepidermoid carcinoma of the oral cavity

Additional relevant MeSH terms:
Head and Neck Neoplasms
Mucositis
Radiation Injuries
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Mouth Diseases
Neoplasms
Neoplasms by Site
Stomatognathic Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014