Clinical trial · Interventional
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
NCT00293462CI-TRIAL-00052991completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Mucositis Oral | — | UNRESOLVED | — |
| Radiation Toxicity | — | UNRESOLVED | — |
| Tongue Cancer | Malignant Tongue Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| oral salt and soda mouthwash | Other | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Arm I: GM-CSF Group (GG)
- description
- 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.
- interventionNames
- Biological: sargramostim
- type
- ACTIVE_COMPARATOR
- label
- Arm II: Salt & Soda Group (SS)
- description
- 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.
- interventionNames
- Other: oral salt and soda mouthwash
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * 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 centigray (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) * Karnofsky performance status 60-100% * Mentally capable of participating in research protocol * Expected survival \> 4.5 months * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Creatinine ≤ 2.0 mg/dL * Bilirubin ≤ 2.0 mg/dL * Aspartate aminotransferase (AST) \< 5 times upper limit of normal * HIV negative Exclusion Criteria * 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 T1 or T2 glottic tumors * No other serious concurrent medical illness * 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 * 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
References
Publications (0)
Data not yet available
No reference posted for this study.