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

NCT02215083 | Withdrawn Phase 1

• 1 other identifier: ERMC 13-32
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Neuropathy

Keywords

peripheral neuropathy; breast cancer; taxane induced peripheral neuropathy; chemotherapy induced peripheral neuropathy

Outcome Measures

Primary Outcomes (1)

• Total sensory neuropathy (area under the curve [AUC]) as measured by the EORTC QLQ-CIPN20 at baseline and week 9

  nine weeks

Secondary Outcomes (1)

• Assess Quality of Life

  nine weeks

Other Outcomes (1)

• Observe progression-free survival for 36 months post-intervention with l-glutamine supplementation

  40 months

Study Arms (1)

L-Glutamine

EXPERIMENTAL

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

Dietary Supplement: L-glutamine

Interventions

L-glutamine 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.

Also known as: Glutamine

L-Glutamine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Eastern Regional Medical Center: lead
• TSPC America, Inc.: collaborator

Study Sites (1)

Eastern Regional Medical Center

Philadelphia, Pennsylvania, 19124, United States

Location

Related Publications (2)

• 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.

  PMID: 15997923 BACKGROUND

• 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.

  PMID: 11350883 BACKGROUND

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Breast Neoplasms

Interventions

Glutamine

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral

Study Officials

• Jack Medendorp

  Eastern Regional Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2014
• First Posted: August 13, 2014
• Study Start: August 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: July 12, 2017

Record last verified: 2017-07

Locations

US (1)