Pain Clinical Trial
Official title:
S9908, A Double-Blind, Placebo-Controlled Trial To Study The Efficacy And Safety Of L-Glutamine (In AES0014 Delivery Vehicle) Upon Radiation Therapy-Induced Oral Mucositis In Head and Neck Cancer Patients, Phase III
RATIONALE: Glutamine may be effective in decreasing side effects, such as inflammation of
the mouth and throat, caused by radiation therapy. The effectiveness of glutamine for
mucositis is not yet known.
PURPOSE: Randomized phase III trial to determine the effectiveness of glutamine in treating
patients who develop mucositis following radiation therapy for newly diagnosed cancer of the
mouth or throat.
OBJECTIVES:
- Compare the efficacy of L-glutamine vs placebo, in terms of maximum mucositis toxic
effects and worst reported mouth pain during and after high-dose radiotherapy, in
patients with newly diagnosed, previously untreated squamous cell cancer of the oral
cavity or oropharynx.
- Compare the duration of severe mucositis in patients treated with these regimens.
- Compare the radiotherapy delay in patients treated with these regimens.
- Compare weight loss in patients treated with these regimens.
- Compare the toxic effects of these two regimens in these patients.
- Compare patient-reported mouth pain success rate in patients treated with these
regimens.
- Determine the compliance of patients treated with this drug regimen.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to concurrent cisplatin or carboplatin (yes vs no), concurrent
fluorouracil (yes vs no), and presence of feeding tube (yes vs no). Patients are randomized
to 1 of 2 treatment arms.
- Arm I: Beginning 4 to 7 days prior to radiotherapy, patients receive oral L-glutamine 3
times daily for 60-80 days. Patients receive concurrent high-dose radiotherapy for
approximately 6 weeks.
- Arm II: Patients receive oral placebo and high-dose radiotherapy as in arm I. In both
arms, treatment continues in the absence of unacceptable toxicity.
Patients are followed for 2 weeks.
PROJECTED ACCRUAL: A total of 158 patients (79 per treatment arm) will be accrued for this
study within 2.5 years.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care
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