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

SWOG Cancer Research Network

Status and phase: Terminated; Phase 3

Conditions: Cancer-related Problem/Condition; Head and Neck Cancer; Pain

Treatments: Drug: l-glutamine placebo; Radiation: radiation therapy; Dietary Supplement: glutamine

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00006994

CDR0000068353

U10CA037429 (U.S. NIH Grant/Contract)

S9908 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Newly diagnosed, previously untreated squamous cell cancer of the oral cavity or oropharynx (T1-T4, any N, M0)
• Must be scheduled to receive high-dose radiotherapy
• Not concurrently receiving or planning to receive treatment on any other Southwest Oncology Group protocol

PATIENT CHARACTERISTICS:

Age:

• 18 to 90

Performance status:

• Zubrod 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer currently in complete remission
• Not pregnant or nursing
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy
• Concurrent cisplatin, carboplatin, or fluorouracil allowed
• No other concurrent chemotherapy during study and for at least 3 weeks after study radiotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

Surgery:

• Not specified

Other:

• No concurrent amifostine during and for 2 weeks after study radiotherapy

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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23 participants in 2 patient groups, including a placebo group

L-glutamine in suspension + radiation

Active Comparator group

Description:

20 cc three times daily for 60 days plus radiation therapy.

Treatment:

Radiation: radiation therapy

Dietary Supplement: glutamine

Placebo in suspension + radiation

Placebo Comparator group

Description:

20 cc three times daily for 60 days plus radiation therapy.

Treatment:

Radiation: radiation therapy

Drug: l-glutamine placebo