NCT00293462

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

Management of Mucositis With GM-CSF (Sargramostim) Mouthwash Study Protocol

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Marilyn Dodd · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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. 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.

Conditions

• Head and Neck Cancer
• Mucositis Oral
• Radiation Toxicity
• Tongue Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2005-06-07
• Primary completion: 2009-12-31
• Completion: 2009-12-31
• First posted: 2006-02-17
• Last updated: 2021-07-30
• Results posted: 2013-05-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study