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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

September 17, 2008
December 15, 2015
June 2006
August 2015   (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 ] [ 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 ]
  • Vibratory threshold as assessed by the Rydel-Seiffer Quantitative Tuning Fork [ Designated as safety issue: No ]
  • Sensitivity to light touch [ Designated as safety issue: No ]
  • Motor and sensory neuropathy as assessed by NCI CTCAE v3.0 [ Designated as safety issue: No ]
  • Toxicity as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
  • Tumor response [ Designated as safety issue: No ]
  • Time to tumor progression [ Designated as safety issue: No ]
  • Survival [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00754767 on ClinicalTrials.gov Archive Site
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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
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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.
 
Completed
2
October 2015
August 2015   (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
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
Not Provided
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