Clinical trial · Interventional
S0715: Acetyl-L-Carnitine in Preventing Neuropathy in Women With Stage I, II, or IIIA Breast Cancer Undergoing Chemo
S0715: Randomized Placebo-Controlled Trial of Acetyl-L-Carnitine (ALC) for the Prevention of Taxane Induced Neuropathy Phase III
NCT00775645CI-TRIAL-00029065completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Acetyl-L-carnitine may prevent or lessen neuropathy caused by chemotherapy. It is not yet known whether acetyl-L-carnitine is more effective than a placebo in preventing neuropathy caused by chemotherapy. PURPOSE: This randomized phase III trial is studying acetyl-L-carnitine to see how well it works compared with a placebo in preventing neuropathy in women with stage I, stage II, or stage III breast cancer undergoing chemotherapy.
Conditions
Conditions (5)
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 | — |
| Fatigue | — | UNRESOLVED | — |
| Neuropathy | — | UNRESOLVED | — |
| Neurotoxicity | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| acetyl-L-carnitine hydrochloride | Dietary Supplement | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks.
- interventionNames
- Dietary Supplement: acetyl-L-carnitine hydrochloride
- type
- PLACEBO_COMPARATOR
- label
- Arm II
- description
- Patients receive oral placebo 3 times daily for 24 weeks.
- interventionNames
- Other: placebo
Primary outcomes (1)
- measure
- 12-week FACT-Taxane Neurotoxicity Model-adjusted Score in ALC and Placebo Groups
- timeFrame
- 12 weeks post-registration
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed primary invasive adenocarcinoma of the breast * Stage I-III disease * No metastatic disease * Must have undergone modified radical mastectomy or breast-sparing surgery * Planning to receive one of the following standard taxane-based systemic chemotherapy regimens as adjuvant therapy for breast cancer: * Paclitaxel 80 mg/m² weekly for 12 weeks * Paclitaxel 175 mg/m² every other week for 4 courses (8 weeks) * Paclitaxel 175 mg/m² every other week for 6 courses (12 weeks) * Docetaxel 75 mg/m² every 3 weeks for 4 courses (12 weeks) * Docetaxel 75 mg/m² every 3 weeks for 6 courses (18 weeks) * No history of neuropathy * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Menopausal status not specified * Zubrod performance status 0-2 * Serum creatinine ≤ 2.5 times upper limit of normal * Not pregnant or nursing * Fertile patients must use effective contraception * Able to complete questionnaires in English or Spanish * Willing to submit blood samples for DNA extraction, genotyping analysis, and nerve growth factor studies * No history of diabetes * No history of seizure disorder * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, ductal carcinoma in situ, or adequately treated stage I or stage II malignancy from which the patient is currently in complete remission PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from prior breast surgery * Prior neoadjuvant or adjuvant chemotherapy allowed * No prior taxane therapy * No prior biologic therapy for treatment of breast cancer * No concurrent vitamin E, glutamine, gabapentin, nortriptyline, amitriptyline, or duloxetine hydrochloride * Multivitamins containing vitamin E allowed provided vitamin E dose is \< 1,000 IU * No concurrent anti-seizure medications * Concurrent hormonal therapy allowed * Concurrent biologic therapy allowed (e.g., Herceptin) * Concurrent participation in another therapeutic clinical trial allowed
References
Publications (1)
- RESULTHershman DL, Unger JM, Crew KD, Minasian LM, Awad D, Moinpour CM, Hansen L, Lew DL, Greenlee H, Fehrenbacher L, Wade JL 3rd, Wong SF, Hortobagyi GN, Meyskens FL, Albain KS. Randomized double-blind placebo-controlled trial of acetyl-L-carnitine for the prevention of taxane-induced neuropathy in women undergoing adjuvant breast cancer therapy. J Clin Oncol. 2013 Jul 10;31(20):2627-33. doi: 10.1200/JCO.2012.44.8738. Epub 2013 Jun 3. PMID 23733756