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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
TSPC America, Inc.
Information provided by (Responsible Party):
Eastern Regional Medical Center
ClinicalTrials.gov Identifier:
NCT02215083
First received: August 11, 2014
Last updated: NA
Last verified: August 2014
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Peripheral Neuropathy
Dietary Supplement: L-glutamine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: L-glutamine Supplementation to Alleviate Symptoms of Taxane-Induced Neuropathy in Patients With Breast Cancer

Resource links provided by NLM:


Further study details as provided by Eastern Regional Medical Center:

Primary Outcome Measures:
  • Total sensory neuropathy (area under the curve [AUC]) as measured by the EORTC QLQ-CIPN20 at baseline and week 9 [ Time Frame: nine weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess Quality of Life [ Time Frame: nine weeks ] [ Designated as safety issue: Yes ]
    • 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


Other Outcome Measures:
  • Observe progression-free survival for 36 months post-intervention with l-glutamine supplementation [ Time Frame: 40 months ] [ Designated as safety issue: No ]
    Quarterly record review to determine progression-free survival for 36 months post-l-glutamine intervention


Estimated Enrollment: 40
Study Start Date: August 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: L-Glutamine
All patients will receive 20-30 grams of l-glutamine daily for 9 weeks (+/- 1 week)
Dietary Supplement: 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.
Other Names:
  • L-glutamine
  • Glutamine
  • l-glutamine

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02215083

Locations
United States, Pennsylvania
Eastern Regional Medical Center
Philadelphia, Pennsylvania, United States, 19124
Sponsors and Collaborators
Eastern Regional Medical Center
TSPC America, Inc.
Investigators
Principal Investigator: Michelle Niesley, ND, MS Eastern Regional Medical Center
  More Information

Publications:
Responsible Party: Eastern Regional Medical Center
ClinicalTrials.gov Identifier: NCT02215083     History of Changes
Other Study ID Numbers: ERMC 13-32
Study First Received: August 11, 2014
Last Updated: August 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Eastern Regional Medical Center:
peripheral neuropathy
breast cancer
taxane induced peripheral neuropathy
chemotherapy induced peripheral neuropathy

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Breast Neoplasms
Neuromuscular Diseases
Nervous System Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 19, 2014