S0715: Randomized Placebo-Controlled Trial of Acetyl-L-Carnitine (ALC) for the Prevention of Taxane Induced Neuropathy Phase III
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 437
- 试验地点
- 295
- 主要终点
- 12-week FACT-Taxane Neurotoxicity Model-adjusted Score in ALC and Placebo Groups
研究概览
简要总结
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.
详细描述
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 Questionnaire at 12 weeks after study registration in women with stage I, II, or IIIA breast cancer undergoing adjuvant taxane-based chemotherapy.
Secondary
- Compare the functional status of these patients using the Trial Outcome Index from the Functional Assessment of Cancer Therapy (FACT)-Taxane Questionnaire.
- Compare fatigue in these patients using the Function Assessment of Chronic Illness Therapy (FACIT)-Fatigue Symptom Module.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Arm II
Patients receive oral placebo 3 times daily for 24 weeks.
干预措施: placebo (Other)
Arm I
Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks.
干预措施: acetyl-L-carnitine hydrochloride (Dietary Supplement)
结局指标
主要结局
12-week FACT-Taxane Neurotoxicity Model-adjusted Score in ALC and Placebo Groups
时间窗: 12 weeks post-registration
Compare whether treatment with acetyl-L-carnitine hydrochloride vs placebo prevents symptoms of neuropathy as measured by the 11-item neurotoxicity (NTX) component of the Functional Assesment of Cancer Therapy (FACT)-Taxane Questionnaire at 12 weeks after study registration in women with breast cancer undergoing adjuvant taxane-based chemotherapy. Linear regression model adjusted for baseline score, taxane regiment, and age. Lower scores indicate worse CIPN. Total possible range is 0 to 64. For more information on this subscale, please see http://www.facit.org/FACITOrg/Questionnaires
次要结局
- 12-week FACT-Trial Outcome Index(TOI) Functional Status Model-adjusted Score in ALC and Placebo Groups(12 weeks post-registration)
- 12-week FACIT-fatigue Model-adjusted Score in ALC and Placebo Groups(12 weeks post-registration)