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L-Carnitine L-Tartrate in Preventing Peripheral Neuropathy Caused By Chemotherapy in Women With Metastatic Breast Cancer

This study has been terminated.
(unable to accrue study participants)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00754767
First Posted: September 18, 2008
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
HealthPartners Institute
September 17, 2008
September 18, 2008
March 1, 2017
April 13, 2017
September 11, 2017
January 2, 2007
April 2, 2008   (Final data collection date for primary outcome measure)
Vibratory Threshold as Assessed by the Rydel-Seiffer Quantitative Tuning Fork [ Time Frame: baseline, days 1 and 2 post chemo x 4 cycles ]
Data was not analyzed due to study termination
  • Vibratory Threshold as Assessed by the Rydel-Seiffer Quantitative Tuning Fork
  • Sensitivity to light touch
  • Motor and sensory neuropathy as assessed by NCI CTCAE v3.0
  • Toxicity as assessed by NCI CTCAE v3.0
  • Tumor response
  • Time to tumor progression
  • Survival
Complete list of historical versions of study NCT00754767 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
L-Carnitine L-Tartrate in Preventing Peripheral Neuropathy Caused By Chemotherapy in Women With Metastatic Breast Cancer
Pilot Study of L-Carnitine Supplementation in the Prevention of Chemotherapy-induced Peripheral Neuropathy in Women With Metastatic Breast Cancer

RATIONALE: L-carnitine L-tartrate may prevent peripheral neuropathy caused by chemotherapy.

PURPOSE: This randomized clinical trial is studying how well L-carnitine L-tartrate works in preventing peripheral neuropathy caused by chemotherapy in women with metastatic breast cancer.

OBJECTIVES:

  • To evaluate the tolerability and usefulness of the dietary supplement, L-carnitine L-tartrate, in the prevention of chemotherapy-induced peripheral neuropathy in women with metastatic breast cancer.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral L-carnitine L-tartrate twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.
  • Arm II: Patients receive oral placebo twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.

Patients complete questionnaires periodically to assess neuropathy, pain, fatigue, sleep, and activities of daily living.

After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
  • Breast Cancer
  • Chemotherapeutic Agent Toxicity
  • Neurotoxicity
  • Drug: L-carnitine L-tartrate
    Given orally
  • Other: placebo
    Given orally
  • Experimental: Arm I
    Patients receive oral L-carnitine L-tartrate twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.
    Intervention: Drug: L-carnitine L-tartrate
  • Placebo Comparator: Arm II
    Patients receive oral placebo twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
May 2, 2008
April 2, 2008   (Final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Diagnosis of breast cancer

    • Metastatic disease
  • Scheduled to receive ≥ 1 of the following chemotherapy drugs:

    • Paclitaxel
    • Docetaxel
    • Capecitabine
    • Gemcitabine hydrochloride

      • Concurrent enrollment in the University of Minnesota study "Population Pharmacokinetics and Pharmacogenetics of Gemcitabine in Adult Patients with Solid Tumors" (Human Subjects Code 0508M72989) required
    • Albumin-bound paclitaxel (Abraxane)
    • Doxorubicin hydrochloride

PATIENT CHARACTERISTICS:

  • Life expectancy ≥ 6 months
  • Serum creatinine < 2.0 mg/dL
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No history of seizures
  • No uncontrolled hypertension
  • No history of stroke
  • No malabsorption syndrome
  • No cognitive impairment
  • No history of psychiatric disability affecting informed consent or compliance with drug intake
  • Able to take oral medication
  • Able to complete questionnaire(s) alone or with assistance

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No concurrent warfarin
  • No concurrent radiotherapy
Sexes Eligible for Study: Female
18 Years to 120 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00754767
CDR0000614311
PNCC-03312-05-C
UMN-0508M72428
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
HealthPartners Institute
HealthPartners Institute
Not Provided
Principal Investigator: Alice Shapiro, PhD Park Nicollet Cancer Center
HealthPartners Institute
October 2015

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