Phase 3 N=409 Randomized Double-blind Supportive Care

S0715: Acetyl-L-Carnitine in Preventing Neuropathy in Women With Stage I, II, or IIIA Breast Cancer Undergoing Chemo

Breast Cancer · Chemotherapeutic Agent Toxicity · Fatigue · Neuropathy · Neurotoxicity

Bottom Line

View on ClinicalTrials.gov: NCT00775645 ↗

Enrolled (actual)

409

Serious AEs

0.2%

Results posted

Apr 2017

Primary outcome: Primary: 12-week FACT-Taxane Neurotoxicity Model-adjusted Score in ALC and Placebo Groups — 35.4; 36.3 units on a scale — p=0.17

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: acetyl-L-carnitine hydrochloride (Dietary_supplement); placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: SWOG Cancer Research Network
Primary completion: Jan 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY 12-week FACT-Taxane Neurotoxicity Model-adjusted Score in ALC and Placebo Groups	35.4; 36.3	0.17
SECONDARY 12-week FACT-Trial Outcome Index(TOI) Functional Status Model-adjusted Score in ALC and Placebo Groups	92.1; 92.3	0.92
SECONDARY 12-week FACIT-fatigue Model-adjusted Score in ALC and Placebo Groups	36.6; 35.3	0.20

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00775645). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.