- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00754767
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- Masonic Cancer Center at University of Minnesota
-
Saint Louis Park, Minnesota, United States, 55426
- Park Nicollet Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
Given orally
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
baseline, days 1 and 2 post chemo x 4 cycles
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alice Shapiro, PhD, Park Nicollet Cancer Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000614311
- PNCC-03312-05-C
- UMN-0508M72428
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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