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S9908: Glutamine in Treating Mucositis Caused by Radiation Therapy in Patients With Newly Diagnosed Cancer of the Mouth or Throat

Phase 3
Terminated
Conditions
Cancer-related Problem/Condition
Pain
Head and Neck Cancer
Interventions
Dietary Supplement: glutamine
Radiation: radiation therapy
Registration Number
NCT00006994
Lead Sponsor
SWOG Cancer Research Network
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
23
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
L-glutamine in suspension + radiationglutamine20 cc three times daily for 60 days plus radiation therapy.
Placebo in suspension + radiationradiation therapy20 cc three times daily for 60 days plus radiation therapy.
Placebo in suspension + radiationl-glutamine placebo20 cc three times daily for 60 days plus radiation therapy.
L-glutamine in suspension + radiationradiation therapy20 cc three times daily for 60 days plus radiation therapy.
Primary Outcome Measures
NameTimeMethod
Effectiveness of L-glutamine for mucositis2 weeks after end of radiation treatment

Evaluate effectiveness of L-glutamine as compared to placebo in terms of: maximum toxicity grade during radiation treatment, mucositis toxicity grade 2 weeks after the end of radiation treatment, and patient reported worst mouth pain two weeks after the end of radiation treatment.

Secondary Outcome Measures
NameTimeMethod
Duration of severe mucositis, radiation treatment delay, and weight loss2 weeks after radiation treatment
Toxicitieswithin 2 weeks after radiation treatment
Compare patient reported mouth pain "success" rate at the end of radiation treatment2 weeks after end of radiation treatment
Compliance (dose taken) in patients treated with L-glutamine when given with radiation treatment2 weeks after end of radiation treatment

Trial Locations

Locations (107)

MBCCOP - Gulf Coast

🇺🇸

Mobile, Alabama, United States

CCOP - Western Regional, Arizona

🇺🇸

Phoenix, Arizona, United States

Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)

🇺🇸

Phoenix, Arizona, United States

Veterans Affairs Medical Center - Tucson

🇺🇸

Tucson, Arizona, United States

Arizona Cancer Center at University of Arizona Health Sciences Center

🇺🇸

Tucson, Arizona, United States

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

🇺🇸

Little Rock, Arkansas, United States

Veterans Affairs Medical Center - Little Rock (McClellan)

🇺🇸

Little Rock, Arkansas, United States

City of Hope Comprehensive Cancer Center

🇺🇸

Duarte, California, United States

Veterans Affairs Medical Center - Long Beach

🇺🇸

Long Beach, California, United States

USC/Norris Comprehensive Cancer Center and Hospital

🇺🇸

Los Angeles, California, United States

Scroll for more (97 remaining)
MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, United States

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