Clinical trial NCT04731441: Exercise Intervention Prior to CRS-HIPEC: Feasibility & Impact
Official title: Exercise Intervention Prior to CRS-HIPEC: Feasibility & Impact
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colon Cancer
Ovarian Cancer
GI Cancer
Gynecologic Cancer
Keywords: HIPEC
CRS
Prehabilitation
Exercise
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2021-02-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: Our objective is to initiate 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)

Detailed 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 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).

Eligibility criteria: Inclusion Criteria:

* Patients with peritoneal metastasis from appendix, colon, small bowel, endometrium, ovary or any other GI or Gyn primary tumor
* Patients should be eligible for and consent to surgery with the intention of performing CRS / HIPEC at Penn State Hershey Medical Center. Eligibility for CRS/HIPEC is a clinical determination based on a combination of factors including radiographic extent of disease, tumor histology and medical fitness for surgery
* Subjects who are explored but found to be unresectable will be included.
* Male or female.
* Patients should be age 18 or above.
* Surgery is planned for not less than 6 weeks and no more than 10 weeks from consultation

Exclusion Criteria:

* Patients who do not consent to surgery.
* Patients who require urgent surgery, sooner than 6 weeks
* Patients receiving neoadjuvant chemotherapy, with no surgical date planned before 10 weeks from consultation. These patients can be enrolled at the time of the follow-up visit, as long as they meet above criteria
* Patients not fluent in English
* Pregnant women
* Prisoners
* Patients with Cognitive Impairment

Primary outcomes:
measure: Acceptability
timeFrame: 1 year
measure: Feasibility of doing exercises
timeFrame: 2 months
Secondary outcomes:
measure: 30-day Complication
timeFrame: 1 month
measure: Quality of Life after CRS-HIPEC
timeFrame: 1 year
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine
name: Colette R Pameijer, MD
role: PRINCIPAL_INVESTIGATOR
References: