L-glutamine Supplementation to Alleviate Symptoms of Taxane-Induced Neuropathy in Patients With Breast Cancer

Withdrawn before enrolling · Phase 1

Conditions studied: Peripheral Neuropathy

In brief

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.

Key facts

Study ID

NCT02215083

Run by

Eastern Regional Medical Center

People needed

0

Starts

2014-08-01

Expected to finish

2015-04-01

Last updated by the study team

2017-07-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Eastern Regional Medical Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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