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Pre-Surgery Exercise for Abdominal Cancer

N/A

Waitlist Available

Led By Colette R Pameijer, MD

Research Sponsored by Milton S. Hershey Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with peritoneal metastasis from appendix, colon, small bowel, endometrium, ovary or any other GI or Gyn primary tumor

Patients aged 18 or above

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial is testing whether a pre-surgery exercise program can reduce complications and improve survival for patients with abdominal cancer who are eligible for and consent to cytoreductive surgery (CRS) and heated intraperitoneal chemotherapy (HIPEC).

Who is the study for?

This trial is for adults with advanced abdominal cancers like ovarian or gastrointestinal cancer, who are planning to undergo CRS and HIPEC surgery at Penn State Hershey Medical Center in no less than 6 weeks but no more than 10 weeks. It's not for pregnant women, prisoners, those needing urgent surgery within 6 weeks, non-English speakers, or patients with cognitive issues.Check my eligibility

What is being tested?

The study tests a home-based exercise program as prehabilitation before CRS-HIPEC surgery. The goal is to see if exercising can lower complications and improve survival quality and length for patients with abdominal cancer undergoing this procedure.See study design

What are the potential side effects?

Since the intervention involves an exercise program tailored to individuals preparing for surgery, potential side effects may include typical exercise-related risks such as muscle strain or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has spread to the lining of my abdomen from a GI or Gyn origin.

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I am 18 years old or older.

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I agree to have surgery aimed at removing cancer and will undergo a special procedure at Penn State Hershey Medical Center.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability

Feasibility of doing exercises

Secondary outcome measures

30-day Complication

Quality of Life after CRS-HIPEC

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Exercise GroupExperimental Treatment1 Intervention

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.

Group II: Education GroupActive Control1 Intervention

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor

492 Previous Clinical Trials

2,798,792 Total Patients Enrolled

Colette R Pameijer, MDPrincipal InvestigatorPenn State College of Medicine

1 Previous Clinical Trials

204 Total Patients Enrolled

Media Library

Home-based Exercise Program Prior to CRS-HIPEC Clinical Trial Eligibility Overview. Trial Name: NCT04731441 — N/A

Colon Cancer Research Study Groups: Exercise Group, Education Group

Colon Cancer Clinical Trial 2023: Home-based Exercise Program Prior to CRS-HIPEC Highlights & Side Effects. Trial Name: NCT04731441 — N/A

Home-based Exercise Program Prior to CRS-HIPEC 2023 Treatment Timeline for Medical Study. Trial Name: NCT04731441 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are taking part in this clinical exploration?

"Affirmative. According to research hosted on clinicaltrials.gov, this investigation is still searching for patients and was posted in March 2021 with the most recent update happening one year later, also in March 2022. 30 participants are sought from a single medical centre."

Answered by AI

Are there any vacancies available for this trial at present?

"Affirmative. According to clinicaltrials.gov, this medical experiment is still searching for participants who meet its criteria; it was initially posted on March 18th 2021 and updated most recently on March 28th 2022. The research team requires 30 patients from a single centre of enrolment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Exercise Intervention Prior to CRS-HIPEC: Feasibility & Impact

Colette Pameijer 2021. "Exercise Intervention Prior to CRS-HIPEC: Feasibility & Impact". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04731441.

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