Pilot Study of L-Carnitine Supplementation in the Prevention of Chemotherapy-induced Peripheral Neuropathy in Women With Metastatic Breast Cancer
- 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
- 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
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
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Vibratory threshold as assessed by the Rydel-Seiffer Quantitative Tuning Fork
baseline, days 1 and 2 post chemo x 4 cycles
Alice Shapiro, PhD
Park Nicollet Cancer Center
United States: Food and Drug Administration
|Park Nicollet Cancer Center||St. Louis Park, Minnesota 55416|
|Masonic Cancer Center at University of Minnesota||Minneapolis, Minnesota 55455|