NCT00775645

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

Study Contact:

Study Phase:

PHASE3

Recruitment Status:

COMPLETED

NCT ID:

NCT00775645

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

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

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

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

Disease(s) and\or Condition(s)

Breast Cancer

Chemotherapeutic Agent Toxicity

Fatigue

Neuropathy

Neurotoxicity

Primary Purpose

SUPPORTIVE_CARE

Intervention/Treatment

- Type: DIETARY_SUPPLEMENT
- Name: acetyl-L-carnitine hydrochloride
- Description: Given orally
- Arm Group Labels: Arm I
- Type: OTHER
- Name: placebo
- Description: Given orally
- Arm Group Labels: Arm II

Sponsor

SWOG Cancer Research Network