Exercise Intervention Prior to CRS-HIPEC: Feasibility & Impact

Penn State Health

Status: Terminated

Conditions: GI Cancer; Colon Cancer; Gynecologic Cancer; Ovarian Cancer

Treatments: Behavioral: Exercise Education; Behavioral: Home-based Exercise Program Prior to CRS-HIPEC

Study type: Interventional

Funder types: Other

Identifiers

NCT04731441

STUDY00015358

Details and patient eligibility

About

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)

Full 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).

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Exercise Group

Experimental group

Description:

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:

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

Education Group

Active Comparator group

Description:

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:

Behavioral: Exercise Education