Status:
TERMINATED
L-Carnitine L-Tartrate in Preventing Peripheral Neuropathy Caused By Chemotherapy in Women With Metastatic Breast Cancer
Lead Sponsor:
HealthPartners Institute
Conditions:
Breast Cancer
Chemotherapeutic Agent Toxicity
Eligibility:
FEMALE
18-120 years
Phase:
PHASE4
Brief Summary
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 per...
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 b...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 2 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 2 2008
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00754767
Start Date
January 2 2007
End Date
May 2 2008
Last Update
September 11 2017
Active Locations (2)
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1
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455
2
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, United States, 55426