Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase II Trial of Selenomethionine as a Modulator of Efficacy and Toxicity of Chemoradiation in Locally-Advanced Squamous Cell Carcinoma of the Head and Neck
- Assess whether selenomethionine (SLM) reduces the incidence of grade 3 or 4 mucositis
in patients with locally advanced squamous cell carcinoma of the head and neck treated
with concurrent cisplatin and radiotherapy over 7 weeks.
- Assess the impact of SLM on tumor complete response rate, relapse-free survival,
overall survival, and quality of life of these patients.
- Assess whether SLM reduces the incidence and severity of treatment-related toxicities,
including xerostomia, renal impairment, and myelosuppression in these patients.
- Assess whether SLM improves chemoradiotherapy dose delivery in these patients.
- Determine the safety of SLM in these patients.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral placebo twice daily in week 1 and then once daily in weeks
2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and
undergo radiotherapy 5 days a week in weeks 2-8.
- Arm II: Patients receive oral selenomethionine twice daily in week 1 and then once
daily in weeks 2-11. Patients also receive cisplatin and radiotherapy as in arm I.
Patients complete quality-of-life questionnaires at baseline and then periodically
After completion of study therapy, patients are followed up periodically.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Incidence of ≥ grade 3 mucositis
Anurag Singh, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|