Video-based Exercise Prehabilitation for Pancreatic Cancer

Overseen By An Ngo-Huang, DO

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Non-English, Unstable cardiac, Recent fracture, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a supervised exercise program can improve outcomes for individuals undergoing chemotherapy for pancreatic cancer. Participants will either receive general advice on increasing physical activity or engage in tele-supervised resistance exercises, known as Video-based Strengthening Exercise Prehabilitation or Tele-PancFit. The goal is to determine if the exercise helps patients feel better and recover more effectively. Individuals with pancreatic cancer who are recommended for chemotherapy and surgery, and who have regular internet access at home, might be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

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 video-based exercise program is safe for pancreatic cancer patients?

Research has shown that exercise programs, including those conducted through videos or at home, are generally safe for people with pancreatic cancer. No reports of serious side effects have emerged from these exercise programs. This indicates that remotely supervised exercises are well-tolerated by patients. For those considering joining this trial, the safety information from past studies is reassuring. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Video-based Exercise Prehabilitation for Pancreatic Cancer trial because it explores a new way to prepare patients for surgery through tele-supervised resistance exercises. Unlike standard care, which typically involves only general advice on physical activity and nutrition, this approach provides hands-on, remote guidance to help patients build strength and stamina before surgery. This method could make a significant difference in recovery times and overall outcomes by actively engaging patients in a structured exercise program, potentially setting a new standard for prehabilitation in cancer care.

What evidence suggests that tele-supervised resistance exercises might be an effective treatment for pancreatic cancer?

This trial will compare two prehabilitation approaches for pancreatic cancer patients. Group A will receive enhanced usual care, including general recommendations to increase physical activity and improve nutrition before surgery. Group B will participate in tele-supervised resistance exercises through a video-based program. Research has shown that video-based exercise programs can greatly benefit people with pancreatic cancer. In one study of 50 patients with surgically removable pancreatic cancer, those who exercised at home significantly improved their physical abilities. These exercises also seemed to enhance patients' overall well-being, even during challenging treatments like chemotherapy. The remotely supervised exercises aim to improve physical function and quality of life. Overall, early findings suggest these exercises might help patients manage their condition more effectively. ^{1 2 3 4 6}

Who Is on the Research Team?

An Ngo-Huang, DO

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with resectable pancreatic cancer, scheduled for chemo followed by surgery. They must be able to do fitness tests and follow the Tele-PancFit exercise program, have Wi-Fi at home for remote sessions, and not be in severe pain or have unstable heart/lung conditions.

Inclusion Criteria

I am set to undergo chemotherapy before surgery for 2-6 months.

Home or community access to wireless internet (Wi-Fi) and agreement to engage with study personnel for real-time tele-RT sessions

Provision of signed and dated informed consent form

Exclusion Criteria

Regular participation in resistance training throughout the month prior to recruitment

Unable to complete baseline assessment questionnaires or functional assessments

Screen failure for exercise safety based on PAR-Q and/or PROMIS questions

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants engage in a video-based strengthening exercise program during chemotherapy treatments

6 months

Remote monitoring and virtual check-ins

Treatment

Participants receive neoadjuvant chemotherapy and monitored exercise program

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tele-supervised resistance exercises

Trial Overview The study compares usual care with a tele-supervised resistance exercise program (Tele-PancFit) during chemotherapy to see if it improves outcomes for patients undergoing treatment for pancreatic cancer.

How Is the Trial Designed?

Group I: Group B-Tele-supervised resistance exercises Experimental Treatment 1 Intervention

Participants will take part in a monitored exercise program. The study team will provide more instructions and information about the program

Group II: Group A-Enhanced Usual Care Experimental Treatment 1 Intervention

Participants will be given general recommendations to increase physical activity and improve nutrition before surgery.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

A randomized trial involving 151 patients with pancreatic cancer showed that both a prescribed exercise program and enhanced usual care led to significant improvements in walking distance, with Arm B (exercise) showing a greater mean increase of 27.3 meters compared to 18.6 meters in Arm A (usual care).

While both groups had similar overall activity levels, Arm B participants increased their strength training sessions significantly more, indicating that a structured exercise program can enhance physical fitness in patients preparing for surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Pragmatic Home-based Exercise Program Concurrent With Neoadjuvant Therapy on Physical Function of Patients With Pancreatic Cancer: The PancFit Randomized Clinical Trial. Ngo-Huang, AT., Parker, NH., Xiao, L., et al.[2023]

In a study involving 20 patients with potentially resectable pancreatic adenocarcinoma, 75% adhered to a home-based exercise program during preoperative chemotherapy, reporting an average of 156 minutes of exercise weekly.

The exercise program was safe, with no adverse events reported, and significantly increased physical activity levels in patients who initially had low baseline activity, suggesting that exercise can be effectively integrated into treatment for pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based exercise during preoperative therapy for pancreatic cancer. Ngo-Huang, A., Parker, NH., Wang, X., et al.[2023]

A tele-prehabilitation program for esophagogastric cancer patients showed high feasibility, with 96% recruitment and retention rates, and no adverse events reported during the 2-4 week intervention.

Participants experienced significant improvements in fatigue, quality of life, physical and emotional well-being, and anxiety, indicating that tele-rehabilitation can effectively enhance preoperative health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Preliminary Effectiveness of a Tele-Prehabilitation Program in Esophagogastric Cancer Patients. Piraux, E., Caty, G., Reychler, G., et al.[2020]

Prehabilitation programs before pancreatic surgery can improve postoperative outcomes, such as reducing delayed gastric emptying and shortening hospital stays, based on a systematic review of six studies involving 193 patients.

Supervised exercise programs showed better adherence and effectiveness in improving muscle mass and function compared to unsupervised programs, highlighting the importance of structured prehabilitation in enhancing recovery after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation prior to surgery for pancreatic cancer: A systematic review. Bundred, JR., Kamarajah, SK., Hammond, JS., et al.[2021]

In a study of 50 patients with resectable pancreatic adenocarcinoma, engaging in a home-based exercise program led to significant improvements in physical function, as measured by tests like the 6-minute walk test and sit-to-stand test.

Increased levels of light physical activity were linked to better health-related quality of life, while more sedentary behavior was associated with lower quality of life, emphasizing the importance of staying active during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-Based Exercise Prehabilitation During Preoperative Treatment for Pancreatic Cancer Is Associated With Improvement in Physical Function and Quality of Life. Ngo-Huang, A., Parker, NH., Bruera, E., et al.[2023]

A systematic review of 7 trials involving 201 patients with pancreatic cancer showed that exercise training is safe and feasible, with no reported adverse events and high retention rates (71% to 90%).

Exercise programs led to significant improvements in cancer-related fatigue, psychological distress, and physical function, suggesting that exercise may positively impact the health and well-being of patients with pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Medicine in the Management of Pancreatic Cancer: A Systematic Review. Luo, H., Galvão, DA., Newton, RU., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05836870

Study Details | NCT05836870 | Tele-PancFit: A Multi-site ... Determine the effects of the Tele-PancFit intervention on secondary physical function, symptom and body composition study measures. Compare changes between ...

2. withpower.com withpower.com/trial/phase-3-pancreatic-neoplasms-9-2023-ebb50

Video-based Exercise Prehabilitation for Pancreatic Cancer In a study of 50 patients with resectable pancreatic adenocarcinoma, engaging in a home-based exercise program led to significant improvements in physical ...

3. npcf.us npcf.us/clinical-trials/tele-pancfit-a-multi-site-trial-of-video-based-strengthening-exercise-prehabilitation-for-patients-with-resectable-pancreatic-cancer/

Tele-PancFit: A Multi-site Trial Of Video-based ... To learn if a supervised exercise program during chemotherapy treatments can help to improve outcomes in patients who have been diagnosed with pancreatic ...

4. mdanderson.org mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2023-0033.html

Tele-PancFit - Clinical Trials Study #2023-0033. Tele-PancFit: a multi-site trial of video-based strengthening exercise prehabilitation for patients with resectable pancreatic cancer.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10330108/

the PancFit randomized clinical trial - PMC - PubMed Central To determine the effects of a preoperative, home-based exercise program on fitness and physical function in patients with pancreatic cancer.

6. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-03448

A Telemedicine Guided Exercise Program for ... This phase III trial compares the effect of a remote (telemedicine) guided prehabilitation (prehab) exercise program (Tele-PancFit) to enhanced usual care.