Selenomethionine in Reducing Mucositis in Patients With Locally Advanced Head and Neck Cancer Who Are Receiving Cisplatin and Radiation Therapy
Condition: 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
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Laryngeal Neoplasms; Oropharyngeal Neoplasms; Squamous Cell Carcinoma of Head and Neck; Nasopharyngeal Carcinoma; Paranasal Sinus Neoplasms; Mucositis; Xerostomia; Laryngeal Diseases
Intervention: selenomethionine; placebo; cisplatin; radiation therapy; quality-of-life assessment
Intervention description: Given PO; Given PO; Given IV; Undergo radiotherapy; Ancillary studies
Intervention MeSH terms: Selenium
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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