Management of Mucositis With GM-CSF (Sargramostim) Mouthwash Study Protocol
- 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
- 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
- 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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
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
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.
Prevention Phase (prior to onset of mucositis): Baseline to onset of mucositis. Actual time variable, mean time: 16.18 days (SD 7.4)
Marylin J. Dodd, RN, PhD, FAAN
University of California, San Francisco
United States: Food and Drug Administration
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