Trials / Terminated

TerminatedNCT01682031

Selenomethionine in Reducing Mucositis in Patients With Locally Advanced Head and Neck Cancer Who Are Receiving Cisplatin and Radiation Therapy

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

Status: Terminated
Phase: Phase 2
Study type: Interventional
Enrollment: 18 (actual)

Sponsor: Roswell Park Cancer Institute · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	selenomethionine	Given PO
OTHER	placebo	Given PO
DRUG	cisplatin	Given IV
RADIATION	radiation therapy	Undergo radiotherapy
PROCEDURE	quality-of-life assessment	Ancillary studies

Timeline

Start date: 2009-06-01
Primary completion: 2012-04-01
Completion: 2012-06-01
First posted: 2012-09-10
Last updated: 2014-08-22
Results posted: 2014-08-22

Locations

2 sites across 2 countries: United States, New Zealand

Source: ClinicalTrials.gov record NCT01682031. Inclusion in this directory is not an endorsement.