Breast Cancer, Chemotherapeutic Agent Toxicity, Neurotoxicity
Conditions
Keywords
neurotoxicity, chemotherapeutic agent toxicity, stage IV breast cancer, recurrent breast cancer
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 peripheral neuropathy caused by chemotherapy in women with metastatic breast cancer.
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.
Interventions
DRUGL-carnitine L-tartrate
Given orally
OTHERplacebo
Given orally
Sponsors
HealthPartners Institute
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vibratory Threshold as Assessed by the Rydel-Seiffer Quantitative Tuning Fork | baseline, days 1 and 2 post chemo x 4 cycles | Data was not analyzed due to study termination |
Countries
United States
Participant flow
Recruitment details
oncology clinic
Participants by arm
| Arm | Count |
|---|---|
| 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.
L-carnitine L-tartrate: Given orally | 2 |
| 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.
placebo: Given orally | 0 |
| Total | 2 |
Baseline characteristics
| Characteristic | Arm I | Arm II | Total | — |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 2 Participants | 0 Participants | 2 Participants | — |
| Race and Ethnicity Not Collected | — | — | 0 Participants | — |
| Region of Enrollment United States | — | — | — | — participants |
| Sex: Female, Male Female | 2 Participants | 0 Participants | 2 Participants | — |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 0 |
| other Total, other adverse events | 0 / 2 | 0 / 0 |
| serious Total, serious adverse events | 0 / 2 | 0 / 0 |
Outcome results
Primary
Vibratory Threshold as Assessed by the Rydel-Seiffer Quantitative Tuning Fork
Data was not analyzed due to study termination
Time frame: baseline, days 1 and 2 post chemo x 4 cycles