Video-based exercise program for patients with pancreatic cancer
Tele-PancFit: A Multi-site Trial of Video-based Strengthening Exercise Prehabilitation for Patients With Resectable Pancreatic Cancer
This study tests if a video-based exercise program can help patients with pancreatic cancer feel better and maintain their strength while they undergo chemotherapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05836870 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of a telesupervised exercise program, Tele-PancFit, for patients with resectable pancreatic cancer undergoing neoadjuvant chemotherapy. Participants will be compared to a control group receiving enhanced usual care, which includes general physical activity recommendations and an activity tracker. The study aims to assess the initiation of adjuvant chemotherapy, quality of life, skeletal muscle maintenance, and tumor characteristics among participants. The intervention includes both resistance exercises and moderate-intensity aerobic activities monitored remotely.
Who should consider this trial
Good fit: Ideal candidates are individuals with biopsy-proven, resectable pancreatic adenocarcinoma who are recommended for neoadjuvant chemotherapy.
Not a fit: Patients with non-resectable pancreatic cancer or those with an ECOG performance status greater than 1 may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could enhance treatment outcomes and quality of life for patients with pancreatic cancer.
How similar studies have performed: Previous studies have shown positive outcomes with exercise interventions in cancer care, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Provision of signed and dated informed consent form * Biopsy-proven pancreatic adenocarcinoma, resectable/borderline resectable (T1-3, N0-2, M0) * Recommended to receive 2-6 months of neoadjuvant chemotherapy followed by surgical resection including participants who have not yet received chemotherapy and participants who have already received their first cycle of chemotherapy. * Willingness to adhere to the Tele-PancFit study intervention * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Able to schedule baseline (T0) appointment for fitness testing and program teaching at the fitness testing location at each study site or able to schedule remote fitness testing and program teaching: 1. Behavioral Research and Treatment Center (BRTC) at MDACC 2. Exercise Physiology laboratory in the Department of Kinesiology and Health Education at UT Austin 3. Outpatient Rehabilitation gymnasium at Banner MDA * Able to understand the description of the study, exercise program, and willing to participate * Home or community access to wireless internet (Wi-Fi) and agreement to engage with study personnel for real-time tele-RT sessions * Age ≥ 18 * Meet all screening requirements (described below). Exclusion criteria: An individual who meets any of the following criteria will be excluded from participation in this study: * Non-English speaking * Has participated in regular RT (RT for all major muscle groups at least twice per week) throughout the month prior to recruitment * Unable to complete the baseline assessment questionnaires or functional assessments * Screen failure for exercise safety based on PAR-Q and/or PROMIS questions as described in section 4.4 (Screening Procedure). * Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV). * Recent fracture or acute musculoskeletal injury that precludes the ability to weight bear fully on all 4 limbs in order to participate in an exercise intervention. * Numeric pain rating scale of ≥7 out of 10 * Myopathic or rheumatologic disease that impacts physical function. * (Females only) Known pregnancy, as communicated to study personnel by clinicians in GI Medical Oncology; females of childbearing potential receive advice to use methods of contraception per usual care.
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: An Ngo-Huang, DO — M.D. Anderson Cancer Center
- Study coordinator: An Ngo-Huang, DO
- Email: ango2@mdanderson.org
- Phone: (713) 745-2327
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.