Trials Sponsors Conditions Drugs Pricing

Conditions

Breast Cancer Chemotherapeutic Agent Toxicity Neurotoxicity

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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

Sponsors & Collaborators

HealthPartners Institute
Otherlead

Study Sites (2)

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455, United States

Park Nicollet Cancer Center

Saint Louis Park, Minnesota, 55426, United States

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 Compounds

Results Point of Contact

Title: Dr. Alice Shapiro
Organization: HealthPartnersInstitute

Study Officials

Alice Shapiro, PhD
Park Nicollet Cancer Center
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

2 participants (actual enrollment reported by the registry).

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

Actual (reported)

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Arm I

Arm II

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Source record

Locations

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Arm I

Arm II

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Source record

Locations