Video-based Exercise Prehabilitation for Pancreatic Cancer

Overseen By An Ngo-Huang, DO

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: M.D. Anderson Cancer Center

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

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing if an exercise program can help pancreatic cancer patients by improving their health.

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 data supports the effectiveness of the treatment Video-based Exercise Prehabilitation for Pancreatic Cancer?

Research shows that home-based exercise programs for pancreatic cancer patients can improve physical function and quality of life. A study found that patients who engaged in regular physical activity, including aerobic and strengthening exercises, experienced significant improvements in walking ability, strength, and overall well-being. ^{1 2 3 4 5}

Is video-based exercise prehabilitation safe for humans?

Research shows that exercise programs, including video-based and home-based exercises, are generally safe for patients with pancreatic cancer, with no reported exercise-related adverse events. ^{1 2 3 5 6}

How is the Tele-supervised resistance exercises treatment different from other treatments for pancreatic cancer?

The Tele-supervised resistance exercises treatment, also known as Tele-PancFit, is unique because it involves video-based, home-based exercise sessions that are supervised remotely, allowing patients to improve their physical fitness and quality of life before surgery. This approach is different from traditional treatments as it focuses on enhancing physical function and well-being through exercise rather than medication or surgery alone. ^{1 2 3 4 5}

Research Team

An Ngo-Huang, DO

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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 18 years old or older.

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

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

Trial Timeline

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

Treatment Details

Interventions

• Tele-supervised resistance exercises (Behavioral Intervention)

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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 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]

References

1. United States 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. [2023]

2. United States 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. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Prehabilitation prior to surgery for pancreatic cancer: A systematic review. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility and Preliminary Effectiveness of a Tele-Prehabilitation Program in Esophagogastric Cancer Patients. [2020]

5. Germany pubmed.ncbi.nlm.nih.gov

Home-based exercise during preoperative therapy for pancreatic cancer. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Exercise Medicine in the Management of Pancreatic Cancer: A Systematic Review. [2023]