L-Carnitine L-Tartrate in Preventing Peripheral Neuropathy Caused By Chemotherapy in Women With Metastatic Breast Cancer
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer, Cancer, Neurology, Neurology |
| Therapuetic Areas: | Neurology, Oncology |
| Healthy: | No |
| Age Range: | 18 - 120 |
| Updated: | 4/21/2016 |
| Start Date: | June 2006 |
| End Date: | October 2015 |
Pilot Study of L-Carnitine Supplementation in the Prevention of Chemotherapy-induced Peripheral Neuropathy in Women With Metastatic Breast Cancer
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.
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.
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.
- 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.
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
We found this trial at
2
sites
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425 E River Pkwy # 754
Minneapolis, Minnesota 55455
Minneapolis, Minnesota 55455
612-624-2620
Masonic Cancer Center at University of Minnesota The Masonic Cancer Center was founded in 1991....
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