Exercise Intervention Prior to CRS-HIPEC: Feasibility & Impact
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Colon Cancer
- GI Cancer
- Gynecologic Cancer
- Ovarian Cancer
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Subjects will be partially randomized to 1 of 2 treatment arms. Sarcopenia will be measured at baseline but is not a criterion for enrollment. Sarcopenic patients will all be in the intervention arm and receive the prehab exercise program. Non-sarcopenic patients will be randomized to the intervention arm or the control arm. The allocation scheme for non-sarcopenic subjects will be made with a computerized random number generator. This will take place the day of consent and subjects will be notified in person by the research assistant before the end of their visit with the surgeon. After randomization, subjects will proceed with a baseline assessment to obtain basic demographics, muscle strength, endurance performance, physical functioning, and physical activity. The subject will then proceed with 6 weeks of participating in the control or intervention arm, followed by surgery and a post-operative assessment. After the post-operative assessment, study is complete.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Our objective is to assess the feasibility and impact of implementing an exercise program for patients with advanced GI or Gyn cancer, as prehabilitation prior to surgery. The objective of the prehabilitation program is to reduce complication rates and improve the length and quality of survival for ...
Our objective is to assess the feasibility and impact of implementing an exercise program for patients with advanced GI or Gyn cancer, as prehabilitation prior to surgery. The objective of the prehabilitation program is to reduce complication rates and improve the length and quality of survival for patients with abdominal cancer. The prehabilitation program will be offered to patients who are eligible for and consent to cytoreductive surgery (CRS) and heated intraperitoneal chemotherapy (HIPEC).
Tracking Information
- NCT #
- NCT04731441
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Colette R Pameijer, MD Penn State College of Medicine
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