search
Back to results

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

Primary Purpose

Peripheral Neuropathy

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
L-glutamine
Sponsored by
Eastern Regional Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Neuropathy focused on measuring peripheral neuropathy, breast cancer, taxane induced peripheral neuropathy, chemotherapy induced peripheral neuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Eastern Regional Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

L-Glutamine

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Assess Quality of Life
Motor neuropathy as measured by the EORTC QLQ-CIPN20 at baseline and week 9 Autonomic symptoms and functioning as measured by the EORTC QLQ-CIPN20 at baseline and week 9 Overall quality of life as measured by the EORTC-30 questionnaire at baseline, 3 weeks, 6 weeks, and week 9 Pain severity as measured by the Visual Analog Numeric Pain Scale at baseline, week 3, week 6 and week 9 Objective assessment performed by Physical Therapy Department as measured by the Functional Gait Assessment at baseline and week 9 Frequency and severity of adverse events reported by the patient in the Symptom Experience Diary and evaluated through clinical assessment by NCI CTCAE v3.0

Full Information

First Posted
August 11, 2014
Last Updated
July 10, 2017
Sponsor
Eastern Regional Medical Center
Collaborators
TSPC America, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02215083
Brief Title
L-glutamine Supplementation to Alleviate Symptoms of Taxane-Induced Neuropathy in Patients With Breast Cancer
Official Title
L-glutamine Supplementation to Alleviate Symptoms of Taxane-Induced Neuropathy in Patients With Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Insufficient Patient Population
Study Start Date
August 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eastern Regional Medical Center
Collaborators
TSPC America, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathy
Keywords
peripheral neuropathy, breast cancer, taxane induced peripheral neuropathy, chemotherapy induced peripheral neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
L-Glutamine
Arm Type
Experimental
Arm Description
All patients will receive 20-30 grams of l-glutamine daily for 9 weeks (+/- 1 week)
Intervention Type
Dietary Supplement
Intervention Name(s)
L-glutamine
Other Intervention Name(s)
Glutamine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total sensory neuropathy (area under the curve [AUC]) as measured by the EORTC QLQ-CIPN20 at baseline and week 9
Time Frame
nine weeks
Secondary Outcome Measure Information:
Title
Assess Quality of Life
Description
Motor neuropathy as measured by the EORTC QLQ-CIPN20 at baseline and week 9 Autonomic symptoms and functioning as measured by the EORTC QLQ-CIPN20 at baseline and week 9 Overall quality of life as measured by the EORTC-30 questionnaire at baseline, 3 weeks, 6 weeks, and week 9 Pain severity as measured by the Visual Analog Numeric Pain Scale at baseline, week 3, week 6 and week 9 Objective assessment performed by Physical Therapy Department as measured by the Functional Gait Assessment at baseline and week 9 Frequency and severity of adverse events reported by the patient in the Symptom Experience Diary and evaluated through clinical assessment by NCI CTCAE v3.0
Time Frame
nine weeks
Other Pre-specified Outcome Measures:
Title
Observe progression-free survival for 36 months post-intervention with l-glutamine supplementation
Description
Quarterly record review to determine progression-free survival for 36 months post-l-glutamine intervention
Time Frame
40 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jack Medendorp
Organizational Affiliation
Eastern Regional Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Eastern Regional Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19124
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15997923
Citation
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.
Results Reference
background
PubMed Identifier
11350883
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs