- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04731441
Exercise Intervention Prior to CRS-HIPEC: Feasibility & Impact
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Colette R Pameijer, MD
- Phone Number: 717-531-5272
- Email: cpameijer@pennstatehealth.psu.edu
Study Contact Backup
- Name: Jorge Benavides, MPH
- Phone Number: 289441 717-531-0003
- Email: jub1647@psu.edu
Study Locations
-
-
Pennsylvania
-
Hershey, Pennsylvania, United States, 17033
- Penn State Hershey Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability
Time Frame: 1 year
|
Rate of enrollment into this trial
|
1 year
|
Feasibility of doing exercises
Time Frame: 2 months
|
The percent of exercises completed by subjects
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
30-day Complication
Time Frame: 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
|
1 month
|
Quality of Life after CRS-HIPEC
Time Frame: 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. |
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Colette R Pameijer, MD, Penn State College of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- STUDY00015358
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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