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

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ClinicalTrials.gov Identifier: NCT00293462
Recruitment Status : Completed
First Posted : February 17, 2006
Results First Posted : May 16, 2013
Last Update Posted : May 16, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE February 16, 2006
First Posted Date  ICMJE February 17, 2006
Results First Submitted Date  ICMJE March 27, 2013
Results First Posted Date  ICMJE May 16, 2013
Last Update Posted Date May 16, 2013
Study Start Date  ICMJE May 2005
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2013)
  • 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) ]
    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) ]
    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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00293462 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2013)
  • Quality of Life During Radiation Therapy [ Time Frame: at baseline, during radiation therapy, and once a month for 3 months after radiation therapy ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE GM-CSF Mouthwash for Preventing and Treating Mucositis in Patients Who Are Undergoing Radiation Therapy for Head and Neck Cancer
Official Title  ICMJE Management of Mucositis With GM-CSF (Sargramostim) Mouthwash Study Protocol
Brief Summary

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.

Detailed Description

OBJECTIVES:

Primary

  • Compare the incidence of radiotherapy (RT)-induced oral mucositis of any grade, using the Radiation Therapy Oncology Group Acute Radiation Morbidity Scoring Criteria (RTOG ARMSC)-Mucous Membrane, in patients treated with 1 of 2 mouthwashes (sargramostim [GM-CSF] or salt and soda). (prevention portion of the study)
  • Compare the effectiveness of the 2 mouthwashes in treating oral mucositis as defined by the incidence of RTOG ARMSC-Mucous Membrane grade 3 and 4 mucositis in patients in 1 of 3 groups (salt and soda, continuing GM-CSF, or new GM-CSF). (treatment portion of the study)

Secondary

  • Compare the effectiveness of the 2 mouthwashes in preventing RT-induced oral mucositis by the following direct indices:

    • Cumulative RT dose prior to onset of oral mucositis (prevention portion only)
    • Severity of RT-induced oral mucositis at onset and during treatment (using Oral Mucositis Assessment Scale [OMAS])
    • Severity of oral mucositis-related pain at onset and during treatment (using OMAS)
    • Incidence of oral mucositis-related infection at onset and during treatment (using OMAS)
    • Severity of oral mucositis-related problems with ingestion of food and fluids at onset and during treatment (using OMAS)
    • Time to healing of RT-induced oral mucositis.
  • Evaluate patients using the following indirect indices of oral mucositis morbidity during the prevention and treatment portions of the study.

    • Tolerance to RT regimen
    • Functional status
    • Quality of life.

OUTLINE: This is a multicenter, randomized, controlled, double-blinded study. Patients are stratified according to radiotherapy dose schedule (standard vs hyperfractionation vs intensity modulation) and concurrent chemotherapy (yes vs no).

  • Prevention (no mucositis): Patients are randomized to 1 of 2 treatment arms.

    • Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily.
    • Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily.

Treatment in both arms continues during 6-7 weeks of radiotherapy and/or the onset of mucositis. Patients also perform PRO-SELF: Mouth Aware (PSMA) twice daily.

  • Treatment (onset of mucositis): Patients who are currently using GM-CSF mouthwash continue use as in prevention. Patients who are currently using salt and soda mouthwash are randomized to 1 of 2 treatment arms.

    • Arm III: Patients receive GM-CSF mouthwash as in arm I.
    • Arm IV: Patients receive salt and soda mouthwash as in arm II. In both arms, treatment continues until the mucositis heals. Patients perform PSMA four times daily during and for 3 months after radiotherapy.

Quality of life is assessed at baseline and periodically after radiotherapy.

After completion of study treatment, patients are followed every once a month for 3 months.

PROJECTED ACCRUAL: A total of 222 patients will be accrued for this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Head and Neck Cancer
  • Mucositis
  • Radiation Toxicity
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Other: oral salt and soda mouthwash
  • 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.
    Interventions:
    • Biological: sargramostim
    • Other: oral salt and soda mouthwash
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 10, 2012)
91
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00293462
Other Study ID Numbers  ICMJE CDR0000459510
UCSF-H452-26184-03 ( Other Identifier: IRB approval number )
FCCC-4626 ( Other Identifier: UCSF Cancer Center )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Marylin J. Dodd, RN, PhD, FAAN University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP