Phase 3 N=91 Randomized Double-blind Supportive Care

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

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

Bottom Line

View on ClinicalTrials.gov: NCT00293462 ↗

Enrolled (actual)

Serious AEs

5.9%

Results posted

May 2013

Primary outcome: Primary: Comparison of Number of Participants With Grade 1 or 2 Oral Mucositis (GM-CSF and SS Groups Only) — 28; 46 participants — p=0.09

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: sargramostim (Biological); oral salt and soda mouthwash (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Marilyn Dodd
Primary completion: Dec 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Comparison of Number of Participants With Grade 1 or 2 Oral Mucositis (GM-CSF and SS Groups Only)	28; 46	0.09
PRIMARY Comparison of the Mean Number of Days for Mucositis to Heal Across by Group	81.5; 79.4; 77.4	0.92
SECONDARY Comparison of the Combined Mean Score on the Overall Quality of Life Questionnaires by Group	6.91; 6.80; 6.77	0.28
SECONDARY Comparison of Combined Mean Score on the Karnofsky Performance Status Scale (KPS) by Group	84.52; 82.93; 83.49	0.78
SECONDARY Comparison of Combined Mean Score on the Pain Questionnaire by Group	2.15; 1.72; 2.15	0.22

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00293462). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.