Exercise Intervention Prior to CRS-HIPEC: Feasibility & Impact

Sponsor

Milton S. Hershey Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04731441

Collaborator

(none)

Enrollment

Location

Arms

46.9

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Colon Cancer Ovarian Cancer GI Cancer Gynecologic Cancer	Behavioral: Home-based Exercise Program Prior to CRS-HIPEC Behavioral: Exercise Education	N/A

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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

Official Title:

Exercise Intervention Prior to CRS-HIPEC: Feasibility & Impact

Actual Study Start Date :

Mar 18, 2021

Anticipated Primary Completion Date :

Feb 14, 2024

Anticipated Study Completion Date :

Feb 14, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exercise Group Exercise Program Subjects randomized to the intervention arm should have 6 weeks of home exercise prior to surgery, with a minimum of 5 weeks and not more than 7 weeks. The program will begin with an exercise consultation appointment with a certified fitness professional. During this consultation participants will receive an exercise manual for individualized home-based exercise and a practical introduction by an exercise and cancer specialist. PowerBlock adjustable dumbbells will be used for resistance training exercises and walking or jogging will be the primary type of aerobic training. The current program design was developed and successfully used with women with breast cancer. Thus, some components may need modification for this group of patients with advanced GI cancer.	Behavioral: Home-based Exercise Program Prior to CRS-HIPEC Exercise Program Subjects randomized to the intervention arm should have 6 weeks of home exercise prior to surgery, with a minimum of 5 weeks and not more than 7 weeks. The program will begin with an exercise consultation appointment with a certified fitness professional. During this consultation participants will receive an exercise manual for individualized home-based exercise and a practical introduction by an exercise and cancer specialist. PowerBlock adjustable dumbbells will be used for resistance training exercises and walking or jogging will be the primary type of aerobic training. The current program design was developed and successfully used with women with breast cancer. Thus, some components may need modification for this group of patients with advanced GI cancer.
Active Comparator: Education Group Subjects randomized to the control arm will receive education and a handbook on the benefits of exercise and will be encouraged to have adequate protein in their diet and provided with the list of high protein foods and nutritional information. These subjects will undergo the same assessments as the intervention arm at all time points. Control subjects will be offered a 6-week home exercise program 3 months after CRS/HIPEC. Results and outcomes will not be recorded.	Behavioral: Exercise Education Control arm: Subjects randomized to the control arm will receive education and a handbook on the benefits of exercise and will be encouraged to have adequate protein in their diet and provided with the list of high protein foods and nutritional information. These subjects will undergo the same assessments as the intervention arm at all time points. Control subjects will be offered a 6-week home exercise program 3 months after CRS/HIPEC, as described in sections 7.2.1-7.2.3. Results and outcomes will not be recorded.

Arm

Intervention/Treatment

Experimental: Exercise Group

Exercise Program Subjects randomized to the intervention arm should have 6 weeks of home exercise prior to surgery, with a minimum of 5 weeks and not more than 7 weeks. The program will begin with an exercise consultation appointment with a certified fitness professional. During this consultation participants will receive an exercise manual for individualized home-based exercise and a practical introduction by an exercise and cancer specialist. PowerBlock adjustable dumbbells will be used for resistance training exercises and walking or jogging will be the primary type of aerobic training. The current program design was developed and successfully used with women with breast cancer. Thus, some components may need modification for this group of patients with advanced GI cancer.

Behavioral: Home-based Exercise Program Prior to CRS-HIPEC

Active Comparator: Education Group

Subjects randomized to the control arm will receive education and a handbook on the benefits of exercise and will be encouraged to have adequate protein in their diet and provided with the list of high protein foods and nutritional information. These subjects will undergo the same assessments as the intervention arm at all time points. Control subjects will be offered a 6-week home exercise program 3 months after CRS/HIPEC. Results and outcomes will not be recorded.

Behavioral: Exercise Education

Control arm: Subjects randomized to the control arm will receive education and a handbook on the benefits of exercise and will be encouraged to have adequate protein in their diet and provided with the list of high protein foods and nutritional information. These subjects will undergo the same assessments as the intervention arm at all time points. Control subjects will be offered a 6-week home exercise program 3 months after CRS/HIPEC, as described in sections 7.2.1-7.2.3. Results and outcomes will not be recorded.

Outcome Measures

Primary Outcome Measures

Acceptability [1 year]
Rate of enrollment into this trial
Feasibility [2 months]
The percent of exercises completed by subjects

Secondary Outcome Measures

30-day Complication [1 month]
• To assess the 30-day rate of complications after prehabilitation and CRS/HIPEC. The rate of complication after CRS/HIPEC is well described in the literature and established in our patient population at Penn State Cancer Institute. Infectious and non-infectious complications and length of stay will be collected
Quality of Life after CRS-HIPEC [1 year]
• To monitor quality of life after prehabilitation and CRS/HIPEC. Quality of life (QOL) after CRS/HIPEC is well described in the literature and was assessed in our patients in a pilot study that is nearly completed. Patient-Reported Outcomes Measurement Information System (PROMIS) T-Scores for Physical Function will be obtained, scores ranging from 20-80, with higher scores reflecting higher physical function. To assess the effects of prehabilitation and CRS/HIPEC on muscle mass. Muscle mass at the level of L3 on cross-sectional imaging will be measured for all subjects at baseline, to determine the presence of sarcopenia. Muscle mass will be measured again after CRS/HIPEC. Changes in muscle mass after CRS/HIPEC are unknown, and the effect of a prehabilitation program in this patient population are also unknown. The results will serve as preliminary data for a future, larger study in this population with more specific hypotheses.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Penn State Hershey Medical Center	Hershey	Pennsylvania	United States	17033

Sponsors and Collaborators

Milton S. Hershey Medical Center

Investigators

Principal Investigator: Colette R Pameijer, MD, Penn State College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Colette Pameijer, Professor, Department of Surgery, Milton S. Hershey Medical Center

ClinicalTrials.gov Identifier:

NCT04731441

Other Study ID Numbers:

STUDY00015358

First Posted:

Feb 1, 2021

Last Update Posted:

Mar 29, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Colette Pameijer, Professor, Department of Surgery, Milton S. Hershey Medical Center

Study Results

No Results Posted as of Mar 29, 2022