Clinical trial · Interventional
S9908: Glutamine in Treating Mucositis Caused by Radiation Therapy in Patients With Newly Diagnosed Cancer of the Mouth or Throat
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Withdrawn due to drug availability and funding
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer-related Problem/Condition | — | UNRESOLVED | — |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| glutamine | Dietary Supplement | — | UNRESOLVED |
| l-glutamine placebo | Drug | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- L-glutamine in suspension + radiation
- description
- 20 cc three times daily for 60 days plus radiation therapy.
- interventionNames
- Dietary Supplement: glutamine
- Radiation: radiation therapy
- type
- PLACEBO_COMPARATOR
- label
- Placebo in suspension + radiation
- description
- 20 cc three times daily for 60 days plus radiation therapy.
- interventionNames
- Radiation: radiation therapy
- Drug: l-glutamine placebo
Primary outcomes (1)
- measure
- Effectiveness of L-glutamine for mucositis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available