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

NCT ID: NCT02215083

Last Updated: 2017-07-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2015-04-30

Brief Summary

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.

Detailed 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.

Conditions

Peripheral Neuropathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

L-Glutamine

All patients will receive 20-30 grams of l-glutamine daily for 9 weeks (+/- 1 week)

Group Type: EXPERIMENTAL

L-glutamine

Intervention Type: DIETARY_SUPPLEMENT

10,000mg by mouth, twice daily for nine weeks (± 7 days) with one permitted dose escalation to a maximum of 10,000mg by mouth three times daily.

Interventions

L-glutamine

10,000mg by mouth, twice daily for nine weeks (± 7 days) with one permitted dose escalation to a maximum of 10,000mg by mouth three times daily.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Glutamine

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TSPC America, Inc.

INDUSTRY

Sponsor Role: collaborator

Eastern Regional Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jack Medendorp

Role: STUDY_DIRECTOR

Eastern Regional Medical Center

Locations

Eastern Regional Medical Center

Philadelphia, Pennsylvania, United States

Countries

United States

References

Stubblefield 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.

Reference Type: BACKGROUND

PMID: 15997923 (View on PubMed)

Vahdat 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.

Reference Type: BACKGROUND

PMID: 11350883 (View on PubMed)

Other Identifiers

ERMC 13-32

Identifier Type: -

Identifier Source: org_study_id