Pilot Study of Mechanical Stimulation for Prevention of Hematopoietic Cell Transplant Associated Bone Density Loss
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Adherence with treatment
研究概览
简要总结
This pilot clinical trial studies mechanical stimulation in preventing bone density loss in patients undergoing donor stem cell transplant. Mechanical stimulation may limit, prevent, or reverse bone loss, increase muscle and cardiac performance, and improve overall health
详细描述
PRIMARY OBJECTIVES:
I. To determine the feasibility of a mechanical stimulation regimen in hematopoietic cell transplant (HCT) patients.
SECONDARY OBJECTIVES:
I. To evaluate the data collection tools to prepare for a larger phase II trial.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Meet eligibility criteria for first allogeneic HCT, and are scheduled to undergo allogeneic HCT
- •Pre-transplant Karnofsky Performance Status (KPS) >= 70
- •Patient or legal representative must understand the investigational nature of this study and sign an Institutional Review Board approved written informed consent form prior to receiving any study related procedure
排除标准
- •Any prior allogeneic HCT
- •Pre-transplant weight >= 280 lbs
- •Body mass index (BMI) < l8kg/m^2
- •Human leukocyte antigen (HLA)-mismatched HCT
- •Cord blood transplant
- •Osteopenia or osteoporosis (T-score =< -1.0)
- •Multiple myeloma diagnosis
- •Any prior history of a central nervous system (CNS) hemorrhage
- •Currently treated with a therapeutic dose of anti-coagulation for a recent pulmonary embolism or deep vein thrombosis
- •Current or previous bisphosphonate use
- •Prior history of non-traumatic fracture
- •Any screws, pins, rods, or other metal objects in the body
- •Total joint replacement
- •History of kidney stones or gall stones
- •Any artificial limbs
- •Pregnant or nursing female patients
- •Unwilling or unable to follow protocol requirements
- •Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study intervention
研究组 & 干预措施
Supportive care (whole body vibration)
Patients undergo mechanical stimulation over 20 minutes QD beginning on date of hospital admission and continuing through day 100 post-HCT, except for day 0 (date of transplant).
干预措施: management of therapy complications (Procedure)
Supportive care (whole body vibration)
Patients undergo mechanical stimulation over 20 minutes QD beginning on date of hospital admission and continuing through day 100 post-HCT, except for day 0 (date of transplant).
干预措施: musculoskeletal complications management/prevention (Procedure)
结局指标
主要结局
Adherence with treatment
时间窗: From hospital admission to 100 days post-HCT
Effective data collection tools and data points
时间窗: From hospital admission to 100 days post-HCT
Refinement of mechanical stimulation protocol
时间窗: From hospital admission to 100 days post-HCT
Best time of day for treatment, staff involvement, etc.
次要结局
未报告次要终点