Clinical trial · Interventional
L-glutamine Supplementation to Alleviate Symptoms of Taxane-Induced Neuropathy in Patients With Breast Cancer
NCT02215083CI-TRIAL-00028577withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient Patient Population
Summary
Brief summary (as posted)
The purpose of the study is to determine whether daily, high-dose administration of l-glutamine can reduce numbness and tingling caused by a taxane chemotherapy in patients with breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peripheral Neuropathy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| L-glutamine | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- L-Glutamine
- description
- All patients will receive 20-30 grams of l-glutamine daily for 9 weeks (+/- 1 week)
- interventionNames
- Dietary Supplement: L-glutamine
Primary outcomes (1)
- measure
- Total sensory neuropathy (area under the curve [AUC]) as measured by the EORTC QLQ-CIPN20 at baseline and week 9
- timeFrame
- nine weeks
Secondary outcomes (1)
- measure
- Assess Quality of Life
- timeFrame
- nine weeks
- description
- * Motor neuropathy as measured by the EORTC QLQ-CIPN20 at baseline and week 9 * Autonomic symptoms and functioning as measured by the EORTC QLQ-CIPN20 at baseline and week 9 * Overall quality of life as measured by the EORTC-30 questionnaire at baseline, 3 weeks, 6 weeks, and week 9 * Pain severity as measured by the Visual Analog Numeric Pain Scale at baseline, week 3, week 6 and week 9 * Objective assessment performed by Physical Therapy Department as measured by the Functional Gait Assessment at baseline and week 9 * Frequency and severity of adverse events reported by the patient in the Symptom Experience Diary and evaluated through clinical assessment by NCI CTCAE v3.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy proven adenocarcinoma of the breast * Received at least one prior taxane-containing chemotherapy regimen which resulted in persistent taxane-induced peripheral neuropathy * Anticipated survival of at least 6 months * Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 0, 1, or 2 * The patient must have screening laboratory: Transaminases\<2.5 x upper limit of normal; total bilirubin \<2.0; creatinine \<1.5 * Neuropathy onset from taxane administration no more than 18 months from date enrolled in trial * Willingness to adhere to supplemental regimen of l-glutamine 10,000mg taken orally twice daily, with one potential dose escalation to 10,000mg taken orally three times daily. * Grade I-III sensory peripheral neuropathy related to prior taxane use as assessed by their treating oncologist at Eastern Regional Medical Center * Able to give informed consent for protocol participation Exclusion Criteria: * Participants are not able to understand or provide written informed consent. * The research team deems that the participant may not be able to follow the study protocol. * Current diagnosis of bipolar disorder or other manic state * Prior use of l-glutamine for prevention or empirical treatment of taxane-induced sensory peripheral neuropathy * Prior treatment with a platinum chemotherapy * Concurrent use of physical therapy interventions such as the 'Rebuilder', chiropractic care, acupuncture, or other modalities specifically targeting peripheral neuropathy * Concomitant use of nutraceutical supplements which may mitigate symptoms of taxane-induced peripheral neuropathy including B-Complex vitamins, alpha-lipoic acid, vitamin E, acetyl-l-carnitine, intramuscular B12 injections, fish oil, etc… during study * Renal insufficiency : serum creatinine of \>1.5 mg /dl * Hepatic insufficiency: transaminases \> 2.5 x upper limit of normal due to isolated reports of possible hepatic encephalopathy * New prescription or dose adjustment of current medication for the treatment of peripheral neuropathy such as gabapentin or Lyrica within the past 30 days. * Pre-existing sensory peripheral neuropathy from other comorbid conditions such as diabetes or alcoholism * Current serious infection or other serious medical condition * Currently active second malignancy other than nonmelanatous skin cancer or carcinoma in situ of the cervix * Pregnant or lactating female (pre-menopausal females will undergo pregnancy test prior to administration of protocol drugs throughout treatment cycles during this study) * Acetaminophen use exceeding 2 g per day-includes use of acetaminophen-containing pain medications such as Percocet.
References
Publications (2)
- BACKGROUNDStubblefield MD, Vahdat LT, Balmaceda CM, Troxel AB, Hesdorffer CS, Gooch CL. Glutamine as a neuroprotective agent in high-dose paclitaxel-induced peripheral neuropathy: a clinical and electrophysiologic study. Clin Oncol (R Coll Radiol). 2005 Jun;17(4):271-6. doi: 10.1016/j.clon.2004.11.014. PMID 15997923
- BACKGROUNDVahdat L, Papadopoulos K, Lange D, Leuin S, Kaufman E, Donovan D, Frederick D, Bagiella E, Tiersten A, Nichols G, Garrett T, Savage D, Antman K, Hesdorffer CS, Balmaceda C. Reduction of paclitaxel-induced peripheral neuropathy with glutamine. Clin Cancer Res. 2001 May;7(5):1192-7. PMID 11350883