Pilot Study of L-Carnitine Supplementation in the Prevention of Chemotherapy-induced Peripheral Neuropathy in Women With Metastatic Breast Cancer
18 Years
N/A
Female
Breast Cancer, Chemotherapeutic Agent Toxicity, Neurotoxicity
Trial Information
Pilot Study of L-Carnitine Supplementation in the Prevention of Chemotherapy-induced Peripheral Neuropathy 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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Outcome Measure:
Vibratory threshold as assessed by the Rydel-Seiffer Quantitative Tuning Fork
Outcome Time Frame:
baseline, days 1 and 2 post chemo x 4 cycles
Safety Issue:
No
Principal Investigator
Alice Shapiro, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Park Nicollet Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000614311
NCT ID:
NCT00754767
Start Date:
June 2006
Completion Date:
Related Keywords:
- Breast Cancer
- Chemotherapeutic Agent Toxicity
- Neurotoxicity
- neurotoxicity
- chemotherapeutic agent toxicity
- stage IV breast cancer
- recurrent breast cancer
- Breast Neoplasms
- Peripheral Nervous System Diseases
- Neurotoxicity Syndromes
Name | Location |
|---|---|
| Park Nicollet Cancer Center | St. Louis Park, Minnesota 55416 |
| Masonic Cancer Center at University of Minnesota | Minneapolis, Minnesota 55455 |
