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S0715: Randomized Placebo-Controlled Trial of Acetyl-L-Carnitine (ALC) for the Prevention of Taxane Induced Neuropathy Phase III

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Trial Conditions
  • Breast Cancer
  • Chemotherapeutic Agent Toxicity
  • Fatigue
  • Neuropathy
  • Neurotoxicity
What is the purpose of this trial?

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.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Female

Eligibility

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

Gender: Female
Steward Physician(s)
  • Laurence H. Baker, DO, FACOI
Facilities
  • St. Elizabeth's Medical Center - Completed
Trial Interventions
Dietary Supplement
  • acetyl-L-carnitine hydrochloride
Other
  • placebo
Physician Researcher

Investigator Name:

  • Laurence H. Baker, DO, FACOI

Other Information

Sponsor: Southwest Oncology Group
Phase: Phase 3
Trial ID: NCT00775645
Volunteers:  Not Accepting Healthy Volunteers

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