The Use of Calcium and Magnesium for Prevention of Ixabepilone Induced Peripheral Neuropathy: A Phase III Double-Blind Placebo Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Comparison of Chemotherapy-induced Peripheral Neuropathy Between Calcium With Magnesium (CaMg) and Placebo Arms, as Measured by the Sensory Subscale of EORTC QLQ-CIPN20
研究概览
简要总结
This randomized phase III trial studies calcium and magnesium to see how well they work in preventing peripheral neuropathy caused by ixabepilone in patients with breast cancer. Giving calcium together with magnesium may stop or delay the development of peripheral neuropathy in patients with cancer who are receiving treatment with ixabepilone. It is not yet known whether calcium and magnesium are effective in preventing peripheral neuropathy caused by ixabepilone.
详细描述
PRIMARY OBJECTIVES:
I. To compare ixabepilone-induced peripheral neuropathy (sensory) as measured by European Organization for Research and Treatment of Cancer (EORTC) Quality of life Questionnaire (QLQ)-Chemotherapy-Induced Peripheral Neuropathy (CIPN)20 sensory subscale between calcium (Ca) Magnesium (Mg) and placebo arms.
SECONDARY OBJECTIVES:
I. To compare the incidence of CTCAE measured grade 2+ and/or grade 3+ peripheral neuropathy between CaMg and placebo arms.
II. To compare the times to onset of CTCAE measured grade 2+ and/or grade 3+ peripheral neuropathy between CaMg and placebo arms.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled to undergo cancer treatment for metastatic breast cancer (weekly or once every three weeks) with ixabepilone with no prior exposure to ixabepilone and no more than 2 prior chemotherapy regimens for metastatic disease
- •Serum calcium =< 1.2 x upper normal limit (UNL)
- •Serum magnesium =< UNL
- •Serum creatinine =< 1.5 x UNL
- •Ability to sign informed consent and understand the nature of a placebo-controlled trial
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2
- •Ability to complete questionnaire(s) by themselves or with assistance
- •Life expectancy >= 4 months
- •Presence of a central line
排除标准
- •Pre-existing history of peripheral neuropathy >= grade 2 (National Cancer Institute [NCI] CTCAE Active Version) due to any cause (chemotherapy, diabetes, alcohol, toxin, hereditary, etc.)
- •Concurrent treatment with anticonvulsants, tricyclic antidepressants, or other neuropathic pain medications agents such as carbamazepine, phenytoin, valproic acid, gabapentin, lamotrigine, topical lidocaine patch, capsaicin cream, etc., or any other treatments specifically for prevention or treatment of neuropathy
- •Other medical conditions, which in the opinion of the treating physician/allied health professional would make this protocol unreasonably hazardous for the patient
- •Any of the following:
- •Pregnant women
- •Nursing women
- •Women of childbearing potential (per physician judgment)
- •Diagnosed diabetes requiring insulin or oral hypoglycemic medications
- •Receiving digoxin or digitoxin
- •History of heart block (any degree)
- •Current treatment for arrhythmias
- •Concurrent treatment with other neuropathic chemotherapy agents
研究组 & 干预措施
Arm I (calcium gluconate, magnesium sulfate)
Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after each ixabepilone administration.
干预措施: Calcium Gluconate (Drug)
Arm I (calcium gluconate, magnesium sulfate)
Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after each ixabepilone administration.
干预措施: Magnesium Sulfate (Drug)
Arm I (calcium gluconate, magnesium sulfate)
Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after each ixabepilone administration.
干预措施: Quality-of-Life Assessment (Other)
Arm I (calcium gluconate, magnesium sulfate)
Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after each ixabepilone administration.
干预措施: Questionnaire Administration (Other)
Arm I (calcium gluconate, magnesium sulfate)
Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after each ixabepilone administration.
干预措施: Ixabepilone (Drug)
Arm II (placebo)
Patients receive placebo IV over 30 minutes immediately before and after each ixabepilone administration.
干预措施: Placebo (Other)
Arm II (placebo)
Patients receive placebo IV over 30 minutes immediately before and after each ixabepilone administration.
干预措施: Quality-of-Life Assessment (Other)
Arm II (placebo)
Patients receive placebo IV over 30 minutes immediately before and after each ixabepilone administration.
干预措施: Questionnaire Administration (Other)
Arm II (placebo)
Patients receive placebo IV over 30 minutes immediately before and after each ixabepilone administration.
干预措施: Ixabepilone (Drug)
结局指标
主要结局
Comparison of Chemotherapy-induced Peripheral Neuropathy Between Calcium With Magnesium (CaMg) and Placebo Arms, as Measured by the Sensory Subscale of EORTC QLQ-CIPN20
时间窗: During the first 18 weeks of ixabepilone-based therapy
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) sensor subscale score was calculated following the standard scoring algorithm and was transformed to a 0 to 100 scale with 0=Low QOL and 100=Best QOL for data analysis.
次要结局
- Severity of the Acute Pain Syndrome (APS)(Treatment initiation to day 21 (Cycle 1))
- Time to Onset of Grade 2+ and/or Grade 3+ Neurotoxicity as Assessed by NCI CTCAE Active Version(Up to 12 months from initiation of ixabepilone)
- Percentage of Patients With Grade 2+ and/or Grade 3+ Neurotoxicity as Measured by NCI CTCAE Active Version Neuropathy Scale(Up to 12 months from initiation of ixabepilone)
- Proportion of Patients Undergoing Dose Reduction or Discontinuing Ixabepilone Secondary to Peripheral Neuropathy(Up to 12 months from initiation of ixabepilone)
- Toxicity Profile of CaMg Per CTCAE Active Version(Up to 12 months from initiation of ixabepilone)
- Incidence of the Acute Pain Syndrome (APS)(Treatment initiation to day 21 (Cycle 1))
- Average Cumulative Ixabepilone Dose(Up to 12 months from initiation of ixabepilone)
- Association Between the Ixabepilone-APS and Eventual Chemotherapy-induced Neuropathy(First cycle of therapy (up to 21 days))