Prehabilitation Program for Cancer Surgery

(RIOT Trial)

Overseen By Aslam Ejaz, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Non-English speaking, prisoners, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special prehabilitation program can improve recovery after surgery for individuals with pancreatic, liver, or stomach cancer. The program includes physical therapy consultations and home exercises, compared to the usual pre-surgery care. The goal is to assess whether these additional steps lead to better outcomes, particularly for patients considered frail, with weakened physical or functional abilities. Individuals scheduled for abdominal cancer surgery or preparing for surgery with treatments might find this trial relevant. As an unphased trial, it offers patients the opportunity to contribute to innovative research that could enhance recovery strategies for future patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this prehabilitation program is safe for cancer surgery patients?

Research has shown that physical therapy and exercise are safe and beneficial for cancer patients undergoing surgery. One study found that pre-surgery exercise is safe, well-received, and aids in better recovery. Another study demonstrated that physical therapy can reduce cancer-related fatigue, which is the persistent feeling of extreme tiredness.

Studies on exercise programs indicate that physical activity can lessen the side effects of cancer treatment and improve overall quality of life. Exercise is also associated with better fitness and strength during cancer treatment. Overall, these treatments are well-tolerated and have produced positive results in improving patient outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential benefits of a prehabilitation program for cancer surgery patients. Unlike the standard of care, which often focuses on post-surgery recovery, this approach emphasizes preparing patients physically before surgery with targeted exercises and physical therapy consultations. This proactive method could enhance surgical outcomes by improving patients' strength and resilience, potentially leading to faster recovery times and fewer complications. By investigating these interventions, researchers hope to find out if enhancing a patient's physical condition before surgery can make a significant difference in their overall recovery and quality of life.

What evidence suggests that this trial's prehabilitation programs could be effective for improving outcomes in cancer surgery?

Research has shown that prehabilitation programs, which include physical therapy and exercise, can assist patients undergoing cancer surgery. In this trial, participants in one arm will have a physical therapy consultation and complete home exercises three days per week. Studies have found that these programs can shorten hospital stays and boost endurance, muscle strength, and breathing. For cancer patients, prehabilitation exercise is considered doable and safe, with no major side effects reported. Physical activities like aerobic and resistance exercises can lessen the side effects of cancer treatment, reduce pain, and improve physical abilities. Overall, exercising during cancer treatment enhances both physical and mental health, making it a promising way to improve recovery after surgery. ^{1 3 4 6 7}

Who Is on the Research Team?

Mark Rubinstein, PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for frail patients who are scheduled for abdominal cancer surgery (pancreatic, liver, or gastric) or planned to have it after neoadjuvant therapy. It's aimed at those who can provide informed consent and speak English. People in prison or unable to give consent cannot participate.

Inclusion Criteria

I am planned for treatment to shrink my tumor before surgery.

I am scheduled for surgery related to abdominal cancer.

Exclusion Criteria

I am unable to understand and give consent for treatment.

Prisoners

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants undergo a prehabilitation program including physical therapy consultation and home exercises 3 days per week

Pre-surgery period

Surgery

Participants undergo surgery for pancreatic, liver, or gastric cancer

Follow-up

Participants are monitored for safety and effectiveness after surgery

12 months

Follow-up at 2 weeks post-surgery and every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Best Practice
• Exercise Intervention
• Physical Therapy
• Questionnaire Administration

Trial Overview The study is testing a prehabilitation program designed to improve patient health before surgery against the usual care given before such surgeries. The goal is to see if this program leads to better recovery outcomes for patients with pancreatic, liver, or gastric cancer.

How Is the Trial Designed?

Group I: Arm I (physical therapy consultation, exercise intervention) Experimental Treatment 3 Interventions

Patients undergo a physical therapy consultation and complete home exercises 3 days per week.

Group II: Arm II (best practice) Active Control 2 Interventions

Patients receive standard of care.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9454950/

Physical Activity and Cancer Care—A Review - PMC The findings from these studies show that physical activity decreases the severity of side effects of cancer treatment, reduces fatigue, improves quality of ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2405844024052241

Efficacy of aerobic and resistance exercises on cancer pain Aerobic and resistance exercises are tolerable and effective adjunct therapies to reduce cancer-related pain while also improving physical function, fatigue ...

3. biosignaling.biomedcentral.com biosignaling.biomedcentral.com/articles/10.1186/s12964-024-01634-6

Outcomes of physical exercises on initiation, progression, and ... Evidence has suggested that participation in physical activity is correlated with a decrease in reappearance and fatality rates of breast cancer patients.

4. aacrjournals.org aacrjournals.org/cancerres/article/81/19/4889/670308/Effects-of-Exercise-on-Cancer-Treatment-Efficacy-A

Effects of Exercise on Cancer Treatment Efficacy: A Systematic ... Exercise significantly enhanced the efficacy of chemotherapy and tamoxifen in seven of eight rodent models in either an additive, sensitizing, or synergistic ...

5. academic.oup.com academic.oup.com/jnci/article/117/1/9/7730230

Exercise and Nutrition to Improve Cancer Treatment-Related ... Exercise interventions during cancer treatment improve self-reported physical functioning, fatigue, anxiety, and depression.

6. sciencedirect.com sciencedirect.com/science/article/pii/S1040842825001064

Physical activity guidelines in oncology: A systematic ... This review aims to summarize the recommendations endorsed by scientific societies regarding physical activity for patients with cancer.

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.22.00687

Exercise, Diet, and Weight Management During Cancer ... Exercise during cancer treatment led to improvements in cardiorespiratory fitness, strength, fatigue, and other patient-reported outcomes.