Clinical trial NCT00754767: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Breast Cancer
Chemotherapeutic Agent Toxicity
Neurotoxicity
Keywords: neurotoxicity
chemotherapeutic agent toxicity
stage IV breast cancer
recurrent breast cancer
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
First posted: 2008-09-18
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Vibratory Threshold as Assessed by the Rydel-Seiffer Quantitative Tuning Fork
timeFrame: baseline, days 1 and 2 post chemo x 4 cycles
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center at University of Minnesota
state: Minnesota
city: Saint Louis Park
country: United States
facility: Park Nicollet Cancer Center
state: Minnesota
Study officials:
affiliation: Park Nicollet Cancer Center
name: Alice Shapiro, PhD
role: PRINCIPAL_INVESTIGATOR
References: