Status:
COMPLETED
S0715: Acetyl-L-Carnitine in Preventing Neuropathy in Women With Stage I, II, or IIIA Breast Cancer Undergoing Chemo
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Chemotherapeutic Agent Toxicity
Eligibility:
FEMALE
18-120 years
Phase:
PHASE3
Brief 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 b...
Detailed Description
OBJECTIVES: Primary * Compare whether treatment with acetyl-L-carnitine hydrochloride vs placebo prevents symptoms of neuropathy as measured by the 11-item neurotoxicity component of the FACT-Taxane...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
437 Patients enrolled
Trial Details
Trial ID
NCT00775645
Start Date
September 1 2009
End Date
June 1 2013
Last Update
August 14 2017
Active Locations (295)
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1
Providence Cancer Center at Providence Hospital
Mobile, Alabama, United States, 36608
2
Alaska Regional Hospital Cancer Center
Anchorage, Alaska, United States, 99508
3
Providence Cancer Center
Anchorage, Alaska, United States, 99508
4
Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
Fairbanks, Alaska, United States, 99701