Neoadjuvant Exercise Therapy in Solid Tumors: A Phase 1b Dose Expansion Trial
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 150
- 主要终点
- change in Ki67 values
研究概览
简要总结
The purpose of this study is to find out whether exercise therapy is an effective and safe treatment that causes few or mild side effects when done before standard surgery for solid tumor cancer. The researchers will also study whether the program is feasible (practical) by tracking how well participants follow the program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Patients with histologically confirmed (on preoperative biopsy), resectable, treatment naïve cancer of one of the following types: head and neck, lung, renal, liver, colorectal, gastric, ovarian, melanoma, pancreas, or breast cancer.
- •Age ≥18 years.
- •An interval of ≥3 weeks until planned surgical resection; surgery will not be delayed to accommodate the minimum length of exercise therapy intervention in any circumstance.
- •Measurable disease based on standard of care radiology scans or confirmation by the surgeon.
- •Body weight ≤ 385 lbs (≤ 174 kg)
- •Non-exercisers, defined as ≤60 minutes of moderate or vigorous exercise/week based on self-report using a validated survey.
- •Cleared for moderate-intensity exercise therapy using the Physical Activity Readiness Questionnaire (PAR-Q)+ with screening clearance provided at the discretion of the PI/exercise physiologist.
- •Willingness to comply with all study-related procedures
排除标准
- •Distant metastases.
- •Receiving any form of antitumor therapy.
- •Enrollment onto any other interventional investigational study except interventions determined by the PI not to confound the effect of exercise on study outcomes.
- •Any other diagnosis of invasive cancer currently requiring active treatment.
- •Any other condition (e.g., pregnancy) or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation.
结局指标
主要结局
change in Ki67 values
时间窗: up to 3 years
With at least one pretreatment (baseline) or postintervention measurement of Ki67 will be considered evaluable. To characterize biological activity of neoadjuvant exercise therapy as defined by the change in tumor cell proliferation marker (Ki67) evaluated in paired formalin-fixed paraffin embedded (FFPE) tumor samples obtained before (diagnostic biopsy) and after (surgical resection) exercise therapy. The biopsies will be collected as part of the standard medical care.
次要结局
未报告次要终点