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L-Carnitine L-Tartrate in Preventing Peripheral Neuropathy Caused By Chemotherapy in Women With Metastatic Breast Cancer

Primary Purpose

Breast Cancer, Chemotherapeutic Agent Toxicity, Neurotoxicity

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

L-carnitine L-tartrate

placebo

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring neurotoxicity, chemotherapeutic agent toxicity, stage IV breast cancer, recurrent breast cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Masonic Cancer Center at University of Minnesota
Park Nicollet Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm I

Arm II

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Vibratory Threshold as Assessed by the Rydel-Seiffer Quantitative Tuning Fork

Data was not analyzed due to study termination

Secondary Outcome Measures

Full Information

NCT ID

NCT00754767

First Posted

September 17, 2008

Last Updated

August 10, 2017

Sponsor

HealthPartners Institute

1. Study Identification

Unique Protocol Identification Number

NCT00754767

Brief Title

L-Carnitine L-Tartrate in Preventing Peripheral Neuropathy Caused By Chemotherapy in Women With Metastatic Breast Cancer

Official Title

Pilot Study of L-Carnitine Supplementation in the Prevention of Chemotherapy-induced Peripheral Neuropathy in Women With Metastatic Breast Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Terminated

Why Stopped

unable to accrue study participants

Study Start Date

January 2, 2007 (Actual)

Primary Completion Date

April 2, 2008 (Actual)

Study Completion Date

May 2, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

HealthPartners Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Chemotherapeutic Agent Toxicity, Neurotoxicity

Keywords

neurotoxicity, chemotherapeutic agent toxicity, stage IV breast cancer, recurrent breast cancer

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm I

Arm Type

Experimental

Arm Description

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 Title

Arm II

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

L-carnitine L-tartrate

Intervention Description

Given orally

Intervention Type

Other

Intervention Name(s)

placebo

Intervention Description

Given orally

Primary Outcome Measure Information:

Title

Vibratory Threshold as Assessed by the Rydel-Seiffer Quantitative Tuning Fork

Description

Data was not analyzed due to study termination

Time Frame

baseline, days 1 and 2 post chemo x 4 cycles

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alice Shapiro, PhD

Organizational Affiliation

Park Nicollet Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Masonic Cancer Center at University of Minnesota

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

Facility Name

Park Nicollet Cancer Center

City

Saint Louis Park

State/Province

Minnesota

ZIP/Postal Code

55426

Country

United States

12. IPD Sharing Statement

Learn more about this trial

L-Carnitine L-Tartrate in Preventing Peripheral Neuropathy Caused By Chemotherapy in Women With Metastatic Breast Cancer

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