L-glutamine Supplementation to Alleviate Symptoms of Taxane-Induced Neuropathy in Patients With Breast Cancer
Sponsored by Eastern Regional Medical Center
About this trial
Last updated 8 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended 10 years ago
What is this trial about?
What are the participation requirements?
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.