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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Alice C. Shapiro, Park Nicollet Institute
ClinicalTrials.gov Identifier:
NCT00754767
First received: September 17, 2008
Last updated: February 25, 2014
Last verified: June 2013

September 17, 2008
February 25, 2014
June 2006
December 2012   (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
Not Provided
Not Provided
Not Provided
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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.
 
Active, not recruiting
20
December 2014
December 2012   (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 and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00754767
CDR0000614311, PNCC-03312-05-C, UMN-0508M72428
No
Alice C. Shapiro, Park Nicollet Institute
Park Nicollet Institute
Not Provided
Principal Investigator: Alice Shapiro, PhD Park Nicollet Cancer Center
Park Nicollet Institute
June 2013

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