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

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ClinicalTrials.gov Identifier: NCT02215083
Recruitment Status : Withdrawn (Insufficient Patient Population)
First Posted : August 13, 2014
Last Update Posted : July 12, 2017
Sponsor:
Collaborator:
TSPC America, Inc.
Information provided by (Responsible Party):
Eastern Regional Medical Center

Tracking Information
First Submitted Date  ICMJE August 11, 2014
First Posted Date  ICMJE August 13, 2014
Last Update Posted Date July 12, 2017
Study Start Date  ICMJE August 2014
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2014)
Total sensory neuropathy (area under the curve [AUC]) as measured by the EORTC QLQ-CIPN20 at baseline and week 9 [ Time Frame: nine weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2014)
Assess Quality of Life [ Time Frame: nine weeks ]
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 11, 2014)
Observe progression-free survival for 36 months post-intervention with l-glutamine supplementation [ Time Frame: 40 months ]
Quarterly record review to determine progression-free survival for 36 months post-l-glutamine intervention
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE L-glutamine Supplementation to Alleviate Symptoms of Taxane-Induced Neuropathy in Patients With Breast Cancer
Official Title  ICMJE L-glutamine Supplementation to Alleviate Symptoms of Taxane-Induced Neuropathy in Patients With Breast Cancer
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Neuropathy
Intervention  ICMJE 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 Name: Glutamine
Study Arms  ICMJE Experimental: L-Glutamine
All patients will receive 20-30 grams of l-glutamine daily for 9 weeks (+/- 1 week)
Intervention: Dietary Supplement: L-glutamine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 29, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: August 11, 2014)
40
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02215083
Other Study ID Numbers  ICMJE ERMC 13-32
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eastern Regional Medical Center
Study Sponsor  ICMJE Eastern Regional Medical Center
Collaborators  ICMJE TSPC America, Inc.
Investigators  ICMJE
Study Director: Jack Medendorp Eastern Regional Medical Center
PRS Account Eastern Regional Medical Center
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP