Xerostomia Clinical Trial
Official title:
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
This randomized phase II trial is studying how well selenomethionine (SLM) works in reducing mucositis in patients with locally advanced head and neck cancer who are receiving cisplatin and radiation therapy. SLM may help prevent or reduce mucositis, or mouth sores, in patients receiving chemotherapy and radiation therapy. It is not yet known whether SLM is more effective than a placebo in reducing mucositis
PRIMARY OBJECTIVES:
I. To assess whether SLM reduces the incidence of grade 3 or 4 mucositis in head and neck
squamous cell carcinoma (HNSCC) patients treated with concurrent chemoradiation (CRT) over 7
weeks.
SECONDARY OBJECTIVES:
I. To assess the impact of SLM on tumor complete response rate, relapse-free survival,
overall survival and quality of life.
II. To assess whether SLM reduces the incidence and severity of treatment-related toxicities
including xerostomia, renal impairment and myelosuppression.
III. To assess whether SLM improves chemoradiation dose delivery. IV. To determine safety of
SLM at this dose. V. In New Zealand (NZ) patients only, to assess the impact of SLM on
plasma free cisplatin and plasma selenium pharmacokinetics (PK) and on pharmacodynamic (PD)
markers of biological activity of selenium.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive placebo orally (PO) twice daily in week 1 and then once daily in
weeks 2-11. Patients also receive cisplatin intravenously (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 selenomethionine PO twice daily in week 1 and then once daily in
weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.
After completion of study treatment, patients are followed up periodically.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Supportive Care
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