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


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Chemotherapeutic Agent Toxicity, Neurotoxicity

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

Vibratory threshold as assessed by the Rydel-Seiffer Quantitative Tuning Fork

Outcome Time Frame:

baseline, days 1 and 2 post chemo x 4 cycles

Safety Issue:

No

Principal Investigator

Alice Shapiro, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Park Nicollet Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000614311

NCT ID:

NCT00754767

Start Date:

June 2006

Completion Date:

Related Keywords:

  • Breast Cancer
  • Chemotherapeutic Agent Toxicity
  • Neurotoxicity
  • neurotoxicity
  • chemotherapeutic agent toxicity
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms
  • Peripheral Nervous System Diseases
  • Neurotoxicity Syndromes

Name

Location
Park Nicollet Cancer Center St. Louis Park, Minnesota  55416
Masonic Cancer Center at University of Minnesota Minneapolis, Minnesota  55455