Clinical trial · Interventional
L-Carnitine L-Tartrate in Preventing Peripheral Neuropathy Caused By Chemotherapy in Women With Metastatic Breast Cancer
Pilot Study of L-Carnitine Supplementation in the Prevention of Chemotherapy-induced Peripheral Neuropathy in Women With Metastatic Breast Cancer
NCT00754767CI-TRIAL-00029464terminatedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): unable to accrue study participants
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chemotherapeutic Agent Toxicity | — | UNRESOLVED | — |
| Neurotoxicity | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| L-carnitine L-tartrate | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- 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.
- interventionNames
- Drug: L-carnitine L-tartrate
- type
- PLACEBO_COMPARATOR
- label
- Arm II
- description
- 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.
- interventionNames
- Other: placebo
Primary outcomes (1)
- measure
- Vibratory Threshold as Assessed by the Rydel-Seiffer Quantitative Tuning Fork
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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 radiotherapyReferences
Publications (0)
Data not yet available
No reference posted for this study.