Exercise Intervention Prior to CRS-HIPEC: Feasibility & Impact
Key facts
- Who runs it
- Milton S. Hershey Medical Center
- Where
- Hershey, United StatesSee the site
- Trial code
- Status
- Terminated
- People taking part
- 12 people enrolled
- Started
- 18 Mar 2021
- Ended
- 1 Dec 2023
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Home-based Exercise Program Prior to CRS-HIPEC
- Exercise Education
- Record updated
- 17 April 2024
- Why it stopped
- Difficulty enrolling and we lost exercise specialist
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 with Cognitive Impairment
- Patients not fluent in English
- Pregnant women
- Prisoners
Where in United States
- Penn State Hershey Medical CenterHershey, United States
About the trial
What the trial wants to find out
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)
The 2 groups in the trial
- Exercise GroupTreatment being tested
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.
Treatment: Home-based Exercise Program Prior to CRS-HIPEC
- Education GroupExisting treatment, for comparison
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.
Treatment: Exercise Education
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 17 April 2024