NCT00754767

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_4 breast-cancer

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_4 breast-cancer

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2008

Completed
8.6 years until next milestone

Results Posted

Study results publicly available

April 13, 2017

Completed
Last Updated

September 11, 2017

Status Verified

October 1, 2015

Enrollment Period

1.2 years

First QC Date

September 17, 2008

Results QC Date

March 1, 2017

Last Update Submit

August 10, 2017

Conditions

Breast CancerChemotherapeutic Agent ToxicityNeurotoxicity

Keywords

neurotoxicitychemotherapeutic agent toxicitystage IV breast cancerrecurrent breast cancer

Outcome Measures

Primary Outcomes (1)

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

    Data was not analyzed due to study termination

    baseline, days 1 and 2 post chemo x 4 cycles

Study Arms (2)

Arm I

EXPERIMENTAL

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

Arm II

PLACEBO COMPARATOR

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.

Other: placebo

Interventions

L-carnitine L-tartrateDRUG

Given orally

Arm I
placeboOTHER

Given orally

Arm II

Eligibility Criteria

Age18 Years - 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Park Nicollet Cancer Center

Saint Louis Park, Minnesota, 55426, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsNeurotoxicity Syndromes

Interventions

Carnitine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNervous System DiseasesPoisoningChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic Chemicals

Results Point of Contact

Title
Dr. Alice Shapiro
Organization
HealthPartnersInstitute
shapia@parknicollet.com
952-993-1704

Study Officials

  • Alice Shapiro, PhD

    Park Nicollet Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2008

First Posted

September 18, 2008

Study Start

January 2, 2007

Primary Completion

April 2, 2008

Study Completion

May 2, 2008

Last Updated

September 11, 2017

Results First Posted

April 13, 2017

Record last verified: 2015-10

Locations

US(2)