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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Chemotherapeutic Agent Toxicity, Mucositis, Radiation Toxicity, Stage III Squamous Cell Carcinoma of the Hypopharynx, Stage III Squamous Cell Carcinoma of the Larynx, Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage III Squamous Cell Carcinoma of the Nasopharynx, Stage III Squamous Cell Carcinoma of the Oropharynx, Stage III Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IV Squamous Cell Carcinoma of the Hypopharynx, Stage IV Squamous Cell Carcinoma of the Larynx, Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IV Squamous Cell Carcinoma of the Nasopharynx, Stage IV Squamous Cell Carcinoma of the Oropharynx, Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Xerostomia

In brief

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

Key facts

Study ID: NCT01682031
Run by: Roswell Park Cancer Institute
People needed: 18
Starts: 2009-06-01
Expected to finish: 2012-06-01
Last updated by the study team: 2014-08-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Biopsy-proven locally-advanced HNSCC, including those with cancers of the oral cavity, oropharynx, hypopharynx, larynx, nasopharynx or paranasal sinuses
Stage III, IVa or IVb disease
No prior definitive surgery for present diagnosis
Appropriate candidate for concurrent cisplatin and radiation as definitive treatment; patients who receive induction chemotherapy as part of a definitive treatment program that will include concurrent CRT are eligible for this study
Hemoglobin >= 10 g/dL (100 g/l)
Absolute neutrophil count >= 2,000 cells/mm\^3 (2 x 10\^9/l)
Platelets >= 100,000 cells/mm\^3 (100 x 10\^9/l)
Serum creatinine =< 1.5 mg/dL (133 umol/l) or calculated creatinine clearance >= 50 ml/min using the Cockcroft-Gault formula
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Able to give written informed consent
Be willing and able to comply with study procedures

You may not qualify if…

Non-regional metastatic disease (stage IVc)
Previous malignancy within the last 5 years except for adequately treated basal or squamous cell carcinoma of the skin or cervical intra-epithelial neoplasia
Prior chemotherapy or radiotherapy for HNSCC, or any prior radiotherapy that would compromise delivery of a radical dose to the HNSCC
Known to be positive for hepatitis C or human immunodeficiency virus (HIV)
Unable to tolerate oral medication (unless a feeding tube is in place)
History of hypersensitivity to platinum drugs
Symptomatic peripheral neuropathy >= National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) grade II
Pregnant, lactating or unwilling to use adequate contraception
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
Planned use of amifostine for prophylaxis against radiation-induced xerostomia
Patients taking selenium supplements in excess of 100 ug/day
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Evidence of any other significant medical disorder or laboratory finding that in the opinion of the Investigator compromises the subject's safety during the study

Where it is running

Roswell Park Cancer Institute — Buffalo, New York, United States
Waikato Hospital — Hamilton, New Zealand

Full record on ClinicalTrials.gov

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