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

Eastern Regional Medical Center

Status and phase

Withdrawn

Phase 1

Conditions

Peripheral Neuropathy

Treatments

Dietary Supplement: L-glutamine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02215083

ERMC 13-32

Details and patient eligibility

About

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.

Full description

L-glutamine has previously been shown to help reduce the incidence of numbness and tingling in patients with breast cancer who are receiving taxane chemotherapies. However, no study to date looks at the effect of l-glutamine given after this numbness and tingling (called 'perihperhal neuropathy') has already occurred. We hypothesize that administration of this amino acid in l-glutamine naïve patients will result in a measureable reduction of their taxane-induced neuropathy.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.