NCT06565052招募中不适用
The Impact of PReOPerative Exercise and NutritionaL Optimization on Perioperative Outcomes for Patients Undergoing Treatment for Rectal Cancer: The PROPEL Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Enrollment Rate
研究概览
简要总结
The purpose of this study is to determine the feasibility of a prehabilitation program for participants diagnosed with rectal cancer undergoing neoadjuvant chemotherapy and/or radiation, followed by surgical resection.
The names of the groups in this research study are:
- Group A: Prehabilitation program
- Group B: Usual Care
详细描述
This is a non-blinded, randomized control trial to determine the feasibility of a hybrid-model, prehabilitation program for participants diagnosed with rectal cancer undergoing neoadjuvant therapy (chemotherapy and/or radiation) before surgical resection. Investigators hope that prehabilitation will result in improved outcomes after surgery.
Participants will be randomized into one of the study groups: Group A: prehabilitation program, or Group B: usual care. Randomization means that a participant is placed into a group by chance.
The research study procedures include screening for eligibility, in-clinic visits, physical exams, exercise training, blood tests, and questionnaires.
It is expected that about 40 participants 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
- Single (Investigator)
盲法说明
Investigators blinded to block size
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
- •Age greater than or equal to 18 years at time of enrollment.
- •English-Speaking.
- •Diagnosis of clinical stage II-III rectal cancer.
- •Planned, ongoing or just completed neoadjuvant treatment, including either 1) chemoradiation, 2) total neoadjuvant therapy (TNT), or 3) chemotherapy only; and anticipated surgical resection to follow.
- •Able to understand the study procedures, agree to participate in the study program, and voluntarily provide informed consent.
排除标准
- •Distant metastatic disease known at the time of diagnosis.
- •Functional incapacity (i.e., incapable of performing exercise testing).
- •Comorbid conditions or cognitive/physical impairments that contraindicate exercise.
- •Currently undergoing treatment for a secondary primary tumor, in addition to primary rectal cancer.
- •Currently enrolled in a separate clinical trial that would prohibit them from performing the tasks instructed in this trial.
- •Currently participating in more than 60 minutes of moderate-to-vigorous aerobic exercise per week over the past month. This study targets insufficiently active persons to assess the effect of the described intervention, where additional exercise done regularly will contaminate the intervention effects.
结局指标
主要结局
Enrollment Rate
时间窗: Baseline
The proportion of eligible individuals that are enrolled to the study. Feasibility of the intervention is defined as an enrollment rate of greater than 10% of approached, eligible participants.
次要结局
- Participant Fall Rate (Group A)(At post-intervention (approximately Week 4))
- Participant Fall Rate (Group B)(At post-intervention (approximately Week 4))
- Change in Hip Circumference from Baseline to Post-Intervention(From baseline to post-operative visit (approximately week 9))
- Change in Clinical Frailty Scale (CFS) Score from Baseline to Post-Surgery (Group A)(From baseline to postoperative visit, up to 9 weeks)
- Length of Hospitalization Post-Surgery (Group A)(30 Days)
- Completion Rate of Physical Function Testing (Group A)(At post-intervention (approximately Week 4))
- Completion Rate of Physical Function Testing (Group B)(At post-intervention (approximately Week 4))
- Completion Rate of Questionnaire Assessments(At baseline and the postoperative visit (approximately Week 9))
- Rate of Hospitalization (Group B)(At post-intervention (approximately Week 4))
- Rate of Musculoskeletal Injury (Group B)(At post-intervention (approximately Week 4))
- Change in Resting Blood Pressure from Baseline to Post-Intervention(From baseline to post-operative visit (approximately week 9))
- Change in Height from Baseline to Post-Intervention(From baseline to post-operative visit (approximately week 9))
- Change in Weight from Baseline to Post-Intervention(From baseline to post-operative visit (approximately week 9))
- Change in Pittsburgh Sleep Quality Index (PSQI) Score from Baseline to Post-Surgery (Group A)(From baseline to postoperative visit, up to 9 weeks)
- Length of Hospitalization Post-Surgery (Group B)(30 Days)
- Discharge Disposition (Group B)(30 Days)
- Discharge Disposition (Group A)(30 Days)
- Adherence Rate to the Prehabilitation Program(At post-intervention (approximately Week 4))
- Change in Short Physical Performance Battery (SPPB) Score from Baseline to Post-Intervention(From baseline to post-operative visit (approximately week 9))
- Change in Waist Circumference from Baseline to Post-Intervention(From baseline to post-operative visit (approximately week 9))
- Change in Body Mass Index from Baseline to Post-Intervention(From baseline to post-operative visit (approximately week 9))
- Change in Nutritional Status from Baseline to Post-Surgery (Group A)(From baseline to postoperative visit, up to 9 weeks)
- Change in Nutritional Status from Baseline to Post-Surgery (Group B)(From baseline to postoperative visit, up to 9 weeks)
- Change in Quality of Life from Baseline to Post-Surgery (Group A)(From baseline to postoperative visit, up to 9 weeks)
- Change in PSQI Score from Baseline to Post-Surgery (Group B)(From baseline to postoperative visit, up to 9 weeks)
- Rate of Hospitalization (Group A)(At post-intervention (approximately Week 4))
- Rate of Musculoskeletal Injury (Group A)(At post-intervention (approximately Week 4))
- Change in Cardiorespiratory Fitness from Baseline to Post-Intervention(From baseline to post-operative visit (approximately week 9))
- Change in Muscle Strength from Baseline to Post-Intervention(From baseline to post-operative visit (approximately week 9))
- Change in Quality of Life from Baseline to Post-Surgery (Group B)(From baseline to postoperative visit, up to 9 weeks)
- Change in Clinical Frailty Scale (CFS) Score from Baseline to Post-Surgery (Group B)(From baseline to postoperative visit, up to 9 weeks)
- Time To Return of Bowel Function Post-Surgery (Group A)(30 Days)
- Time To Return of Bowel Function Post-Surgery (Group B)(30 Days)
研究者
Jeffrey A. Meyerhardt, MD
Principal Investigator
Dana-Farber Cancer Institute
研究点 (4)
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