L-Carnitine L-Tartrate in Preventing Peripheral Neuropathy Caused By Chemotherapy in Women With Metastatic Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00754767|
Recruitment Status : Terminated (unable to accrue study participants)
First Posted : September 18, 2008
Results First Posted : April 13, 2017
Last Update Posted : September 11, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Chemotherapeutic Agent Toxicity Neurotoxicity||Drug: L-carnitine L-tartrate Other: placebo||Phase 4|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||Pilot Study of L-Carnitine Supplementation in the Prevention of Chemotherapy-induced Peripheral Neuropathy in Women With Metastatic Breast Cancer|
|Actual Study Start Date :||January 2, 2007|
|Actual Primary Completion Date :||April 2, 2008|
|Actual Study Completion Date :||May 2, 2008|
U.S. FDA Resources
Experimental: 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.
Drug: L-carnitine L-tartrate
Placebo Comparator: 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.
- Vibratory Threshold as Assessed by the Rydel-Seiffer Quantitative Tuning Fork [ Time Frame: baseline, days 1 and 2 post chemo x 4 cycles ]Data was not analyzed due to study termination
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00754767
|United States, Minnesota|
|Masonic Cancer Center at University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Park Nicollet Cancer Center|
|Saint Louis Park, Minnesota, United States, 55426|
|Principal Investigator:||Alice Shapiro, PhD||Park Nicollet Cancer Center|