Exercise as a Preventive Agent to Combat Immobility in Patients With Ovarian or Endometrial Cancers Receiving Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Proportion of patients completing the exercise intervention sessions.
研究概览
简要总结
The purpose of this research is to determine whether a 16-week virtually supervised aerobic and resistance exercise program is feasible in patients receiving first-line chemotherapy after surgery for ovarian or endometrial cancer and if it will improve lower extremity function (function of the legs), lessen chemotherapy-induced peripheral neuropathy (CIPN; numbness or tingling in the hands or feet), and if there is any effect on inflammatory blood markers (the level of a certain marker in the blood that is associated with inflammation; redness and swelling).
详细描述
This research study is a randomized controlled trial that will compare an exercise group to a control group on lower extremity function, CIPN, and inflammatory markers in ovarian or endometrial cancer patients undergoing first-line chemotherapy after surgery.
The names of the study interventions involved in this study are/is:
- Aerobic and resistance exercise; virtually supervised 16-week aerobic and resistance exercise performed at home via Zoom
- Attention control for 16 weeks, home-based stretching
The research study procedures include: screening for eligibility and study interventions including evaluations and follow up visits.
It is expected that about 30 people will take part in this research study.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed patients with stages III-IV ovarian or endometrial cancer
- •Receiving first-line carboplatin and paclitaxel chemotherapy after surgery
- •≥18 years, children under the age of 18 will be excluded due to rarity of disease
- •Physician's clearance to participate in moderate-vigorous intensity exercise
- •Able to read, write, and understand English
- •Ability to understand and the willingness to sign an informed consent document
- •Willing to undergo two venous blood draws for the study
排除标准
- •Pre-existing musculoskeletal, neurological, or cardiorespiratory conditions, as determined by the treating oncologist
- •Participants with uncontrolled intercurrent illness, as determined by the treating oncologist
- •Participants with psychiatric illness/social situations that would limit compliance with study requirements, as determined by the treating oncologist
- •Participants who have received prior chemotherapy for cancer treatment (e.g. taxanes for breast cancer)
研究组 & 干预措施
Exercise
Participants randomized to one of two groups with 2:1 ratio: exercise (n=20)
- Aerobic and Resistance Exercise for 16 weeks
干预措施: Exercise (Other)
Attention Control
Participants randomized to one of two groups with attention control (n=10).
-Attention Control for 16 weeks home-based stretching
干预措施: Attention Control (Other)
结局指标
主要结局
Proportion of patients completing the exercise intervention sessions.
时间窗: 16 Weeks
The feasibility of the 16-week exercise intervention is defined as the proportion of patients completing the exercise intervention sessions. The analysis population will be the eligible patients who are assigned to the intervention group (N=20). The investigators will estimate the proportion and corresponding 95% exact confidence interval (CI).99 The Investigators expect that the proportion is 70% or higher
Enrollment Rate
时间窗: 16 Weeks
The enrollment rate is defined as the proportion of patients who participate in the study among those patients who are approached for the enrollment.
次要结局
- Change in 6-minute walk distance(16 weeks)
- Short Physical Performance Battery (SPPB)-Lower Extremity Function(16 Weeks)
- PROMIS- Physical function(16 Weeks)
- Number of Participants with Treatment Related Adverse Events(16 Weeks)
研究者
Christina Dieli-Conwright, PhD
Principal Investigator
Dana-Farber Cancer Institute