Modulating The Toxicity And Efficacy Of High Dose Chemotherapy For Multiple Myeloma Through An Intervention To Increase Lean Body Mass
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Number of Adverse Events
研究概览
简要总结
This study will establich the feasibility of weight lifting exercise among patients with multiple myeloma, determine if weight lifting exercise increases lean body mass among patients with multiple myeloma and obtain further preliminary data on toxicity and pharmacokinetics of high-dose melphalan.
详细描述
This is a prospective, single-institution, pilot study of a 3 month weight lifting program designed to increase musle hypertrophy prior to starting stem cell collection and receiving high-dose melphalan, in patients with multiple myeloma. We will use this exercise intervention while patients are receiving initial induction chemotherapy in the 3-6 month period before they receiv high-dose melphalan. The primary study endpoint is to determine the feasibility of recruiting and retaining multiple myeloma patients to an exercise intervention trial. The secondary study endpoint is to determine whether the weight lifting program increases lean body mass as intended.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Histologically confirmed multiple myeloma
- •1 year since start of treatment for myeloma
- •Patient and treating physician in agreement to proceed with autologous transplant, with a planned time betwwen study enrollment and transplant of 10 weeks
- •Age 18 years.
- •Able to walk for 6 minutes unaided.
- •Body mass index 50 kg/m2
- •Serum creatinine 2.5 mg/dL
- •Ability to understand the informed consent document and willingness to consent. Written informed consent must be obtained from all patients before study entry.
排除标准
- •Recent (in the past 6 months) participation in progressive weight lifting exercises or who already exercise regulary (3 times a week of moderate intensity aerobic exercise).
- •Plan to move out of the area during the study intervention.
- •A psychological, social, or logistical barrier that the principal investigators feel would preclude completion of the study protocol.
- •Plan for use of any anti-myeloma treatment other than melphalan (the use of total body irradiation will NOT
结局指标
主要结局
Number of Adverse Events
时间窗: 3-6 months
次要结局
未报告次要终点