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

This study has been terminated.
(Withdrawn due to drug availability and funding)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00006994
First received: December 6, 2000
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Cancer-related Problem/Condition
Head and Neck Cancer
Pain
Dietary Supplement: glutamine
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Effectiveness of L-glutamine for mucositis [ Time Frame: 2 weeks after end of radiation treatment ] [ Designated as safety issue: No ]
    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:
  • Duration of severe mucositis, radiation treatment delay, and weight loss [ Time Frame: 2 weeks after radiation treatment ] [ Designated as safety issue: No ]
  • Toxicities [ Time Frame: within 2 weeks after radiation treatment ] [ Designated as safety issue: Yes ]
  • Compare patient reported mouth pain "success" rate at the end of radiation treatment [ Time Frame: 2 weeks after end of radiation treatment ] [ Designated as safety issue: No ]
  • Compliance (dose taken) in patients treated with L-glutamine when given with radiation treatment [ Time Frame: 2 weeks after end of radiation treatment ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: November 2001
Study Completion Date: April 2006
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: L-glutamine in suspension + radiation
20 cc three times daily for 60 days plus radiation therapy.
Dietary Supplement: glutamine
20 cc three times daily for 60 days
Other Names:
  • l-glutamine
  • NSC-143503
Radiation: radiation therapy
Per institutional standard; minimum of 6,000 cGy with a daily dose of 180-200 cGy.
Placebo Comparator: Placebo in suspension + radiation
20 cc three times daily for 60 days plus radiation therapy.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006994

  Show 107 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: V. S. Klimberg, MD University of Arkansas
  More Information

No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00006994     History of Changes
Other Study ID Numbers: CDR0000068353, S9908, U10CA037429
Study First Received: December 6, 2000
Last Updated: January 17, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Southwest Oncology Group:
oral complications of radiation therapy
pain
radiation toxicity
stage I squamous cell carcinoma of the lip and oral cavity
stage II squamous cell carcinoma of the lip and oral cavity
stage III squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
stage I squamous cell carcinoma of the oropharynx
stage II squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx

Additional relevant MeSH terms:
Head and Neck Neoplasms
Mouth Neoplasms
Mucositis
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 20, 2014