Selenomethionine in Reducing Mucositis in Patients With Locally Advanced Head and Neck Cancer Who… (NCT01682031) | Clinical Trial Compass
TerminatedPhase 2
Selenomethionine in Reducing Mucositis in Patients With Locally Advanced Head and Neck Cancer Who Are Receiving Cisplatin and Radiation Therapy
Stopped: Due to a lack of funding
United States, New Zealand18 participantsStarted 2009-06
Plain-language 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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* …