Expired Study
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Minneapolis, Minnesota 55455


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.


Study summary:

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.


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


NCT ID:

NCT00754767


Primary Contact:

Principal Investigator
Alice Shapiro, PhD
Park Nicollet Cancer Center


Backup Contact:

N/A


Location Contact:

Minneapolis, Minnesota 55455
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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