Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT00754767
Status:
TERMINATED
Last Update Posted:
2017-09-11
First Post:
2008-09-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
L-Carnitine L-Tartrate in Preventing Peripheral Neuropathy Caused By Chemotherapy in Women With Metastatic Breast Cancer
Sponsor:
HealthPartners Institute
Organization:
Study Overview
Official Title:
Pilot Study of L-Carnitine Supplementation in the Prevention of Chemotherapy-induced Peripheral Neuropathy in Women With Metastatic Breast Cancer
Status:
TERMINATED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
unable to accrue study participants
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: