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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 completed.
Sponsor:
Information provided by (Responsible Party):
HealthPartners Institute
ClinicalTrials.gov Identifier:
NCT00754767
First received: September 17, 2008
Last updated: December 15, 2015
Last verified: October 2015
  Purpose

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.


Condition Intervention
Breast Cancer
Chemotherapeutic Agent Toxicity
Neurotoxicity
Drug: L-carnitine L-tartrate
Other: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Pilot Study of L-Carnitine Supplementation in the Prevention of Chemotherapy-induced Peripheral Neuropathy in Women With Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by HealthPartners Institute:

Primary Outcome Measures:
  • Vibratory threshold as assessed by the Rydel-Seiffer Quantitative Tuning Fork [ Time Frame: baseline, days 1 and 2 post chemo x 4 cycles ] [ Designated as safety issue: No ]
  • Sensitivity to light touch [ Time Frame: baseline, days 1 and 2 post chemo x 4 cycles ] [ Designated as safety issue: No ]
  • Motor and sensory neuropathy as assessed by NCI CTCAE v3.0 [ Time Frame: baseline, days 1 and 2 post chemo x 4 cycles ] [ Designated as safety issue: No ]
  • Toxicity as assessed by NCI CTCAE v3.0 [ Time Frame: baseline, days 1 and 2 post chemo x 4 cycles ] [ Designated as safety issue: Yes ]
  • Tumor response [ Time Frame: end of cancer treatment ] [ Designated as safety issue: No ]
  • Time to tumor progression [ Time Frame: to end of cancer treatement ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: to end of course of cancer treatment ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: June 2006
Study Completion Date: October 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: L-carnitine L-tartrate
Given orally
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.
Other: placebo
Given orally

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00754767

Locations
United States, Minnesota
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455
Park Nicollet Cancer Center
St. Louis Park, Minnesota, United States, 55426
Sponsors and Collaborators
HealthPartners Institute
Investigators
Principal Investigator: Alice Shapiro, PhD Park Nicollet Cancer Center
  More Information

Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT00754767     History of Changes
Other Study ID Numbers: CDR0000614311  PNCC-03312-05-C  UMN-0508M72428 
Study First Received: September 17, 2008
Last Updated: December 15, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by HealthPartners Institute:
neurotoxicity
chemotherapeutic agent toxicity
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Peripheral Nervous System Diseases
Neurotoxicity Syndromes
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neuromuscular Diseases
Nervous System Diseases
Poisoning
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on September 30, 2016