Pancreatic Cancer > Tele-supervised Resistance Exercises

Video-based Exercise Prehabilitation for Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

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.

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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.

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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.

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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

Participant Groups

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.

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

M D Anderson Cancer Center Houston, TX

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center Lead Sponsor

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] Purpose: To investigate relationships among physical activity, changes in physical function, and health-related quality of life (HRQOL) among patients with pancreatic adenocarcinoma enrolled in a home-based exercise prehabilitation program. Methods: Patients with resectable pancreatic adenocarcinoma receiving preoperative chemotherapy and/or chemoradiation were enrolled on this prospective, single-arm trial and were advised to perform ≥60 minutes each of moderate-intensity aerobic exercise and strengthening exercise weekly. Activity was measured via self-report and accelerometers, including moderate-to-vigorous physical activity (MVPA), light physical activity (LPA), and sedentary activity (SA). Physical function measures at baseline and restaging follow-up included 6-minute walk test (6MWT), 5 times sit-to-stand (5×STS), handgrip strength (HGS), 3-m walk for gait speed (GS), and the PROMIS Physical Function Short Form. HRQOL was measured via the FACT-Hep questionnaire. Results: Fifty participants with mean age 66 years (standard deviation = 8 years) were enrolled. The 6MWT, 5×STS, and GS significantly improved from baseline to restaging follow-up (P=.001, P=.049, and P=.009, respectively). Increases in self-reported aerobic exercise, weekly MVPA, and LPA were associated with improvement in 6MWT (β=.19, P=.048; β=.18, P=.03; and β=.08, P=.03, respectively) and self-reported physical functioning (β=.02, P=.03; β=.03, P=.005; and β=.01, P=.02, respectively). Increased weekly LPA was associated with increased HRQOL (β=.03, P=.02). Increased SA was associated with decreased HRQOL (β=-.02,P=.01). Conclusions: Patients with potentially resectable pancreatic cancer exhibit meaningful improvement in physical function with prehabilitation; physical activity was associated with improved physical function and HRQOL. These data highlight the importance of physical activity during treatment for pancreatic cancer.

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] To determine the effects of a preoperative, home-based exercise program on fitness and physical function in patients with pancreatic cancer.

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

Prehabilitation prior to surgery for pancreatic cancer: A systematic review. [2021] Prehabilitation aims to improve fitness and outcomes of patients undergoing major surgery. This systematic review aimed to appraise current available evidence regarding the role of prehabilitation in patients undergoing oncological pancreatic resection.

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

Feasibility and Preliminary Effectiveness of a Tele-Prehabilitation Program in Esophagogastric Cancer Patients. [2020] Tele-rehabilitation provides better access to healthcare services and optimizes exercise adherence. However, its feasibility and effectiveness are unknown in the preoperative period in esophagogastric cancer patients. We aimed to assess the feasibility and the preliminary effects of a "tele-prehabilitation" program in esophagogastric cancer patients requiring surgery. Enrolled participants performed an internet-based tele-prehabilitation including aerobic, resistance and inspiratory muscle training over 2-4 weeks. The primary outcome was feasibility, measured in terms of recruitment, retention and attendance rates, adverse events and patient satisfaction. Secondary outcomes (functional exercise capacity, fatigue, quality of life, anxiety and depression) were assessed at baseline, presurgery, and 4 and 12 weeks postsurgery. Among the 24 eligible subjects, 23 were enrolled, 22 performed the intervention and 15 completed the study. Recruitment and retention rates were both 96%. Attendances to aerobic and resistance sessions and inspiratory muscle training were 77% and 68%, respectively. No adverse events occurred, and the satisfaction was excellent. After prehabilitation, participants significantly improved fatigue (p = 0.039), quality of life (p = 0.009), physical well-being (p = 0.034), emotional well-being (p = 0.005) and anxiety (p = 0.044). This study demonstrated the feasibility of a tele-prehabilitation in esophagogastric cancer patients undergoing surgery, with a high recruitment rate, retention rate and satisfaction, a good attendance to exercise sessions and no exercise-related adverse events.

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

Home-based exercise during preoperative therapy for pancreatic cancer. [2023] Exercise concurrent with neoadjuvant chemotherapy and/or chemoradiation for pancreatic adenocarcinoma (PDAC) may mitigate the decline in function that may occur as a result of the disease or its treatment in the preoperative period. The primary objective of this single-arm prospective trial was to determine adherence to a home-based exercise program administered during preoperative therapy.

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

Exercise Medicine in the Management of Pancreatic Cancer: A Systematic Review. [2023] The aim of this study was to examine the health-related effects of exercise in patients with pancreatic cancer (PanCa) through a systematic review of current evidence. Studies were obtained through searching PubMed, Web of Science, PsycINFO, Embase, CINAHL Plus, and Cochrane Library databases with additional hand searches. All intervention-based studies were included if it involved (1) adult patients with PanCa, (2) exercise training, and (3) findings in quality of life, cancer-related fatigue, psychological distress, and physical function. The review protocol was registered in PROSPERO: CRD42020154684. Seven trials described in 9 publications were included consisting of 201 patients with early-stage and advanced PanCa. Participants were required to perform supervised and/or home-based, low- to moderate-intensity resistance and/or aerobic exercise for 12 to 35 weeks or duration of neoadjuvant therapy. There were no exercise-related adverse events with a reported retention rate of 71% to 90% and exercise attendance of 64% to 96%. The programs were consistently associated with improvements in cancer-related fatigue, psychological distress, and physical function, with mixed effects on quality of life. Exercise training seems to be safe and feasible and may have a beneficial effect on various physical and psychological outcomes in patients with PanCa. Further work with rigorous study designs is required to consolidate and advance current findings.