Comprehensive Multimodal Prehabilitation Alone or in Combination With Planned Neoadjuvant Therapy in High-risk Patients Prior to Elective Major Cancer Surgery
The Methodist Hospital Research Institute
Summary
In this 2-arm, non-randomized, phase II trial, the investigators will evaluate the efficacy and safety of comprehensive multimodal prehabilitation (CMMP) alone or in combination with planned neoadjuvant (NAT) in pre-frail/frail patients with probable/proven pancreaticobiliary, ovarian, kidney, or bladder cancer prior to elective major cancer surgery (EMCS).
Description
This is a 2-arm, non-randomized, phase II trial evaluating the efficacy and safety of comprehensive multimodal prehabilitation (CMMP) alone or in combination with planned/off-protocol neoadjuvant therapy (NAT) in high-risk (pre-frail/frail) patients with probable/proven pancreaticobiliary, ovarian, renal, or bladder cancer prior to elective major cancer surgery (EMCS, including pancreatectomy \[N=38 in each study arm\], cytoreduction \[N=12 in each study arm\], radical nephrectomy \[N=12 in each study arm\], or total cystectomy \[N=12 in each study arm\]; respectively and accounting for a pote…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Patients are eligible for entry into the study (First Registration) only if ALL of the following criteria apply. No exceptions or waivers will be granted for patients who do not meet the eligibility criteria. * Signed informed consent form. * Age ≥18 years at time of signing informed consent form. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 per the treating cancer surgeon (Arm 1, Neoadjuvant therapy) or per both the treating cancer surgeon and the medical and/or radiation oncologists (Arm 2, no neoadjuvant therapy). * Pre-frail or frail (based on…
Interventions
- OtherComprehensive multimodal prehabilitation (CMMP)
Components of the CMMP intervention (which will be administered for at least 3 weeks from study registration to the Preoperative Reassessment) will include: 1) Motivational interviewing: 2 sessions, 10-15 minutes each. 2) Nutritional prehabilitation (a supplement containing 18-22g high quality protein consumed 2 times/day, 7 days/week). 3) Inspiratory muscle training using a hand-held inspiratory muscle device, 5 minutes of respiratory muscle training twice/day, 5 days per week. 4) Physical prehabilitation a) aerobic exercise (20 minutes of moderate-intensity exercise at least 3 days/week) and b) strength resistance training using resistance bands (3 sets of 10 repetitions at moderate intensity at least 3 days/week).
Location
- Houston Methodist Neal Cancer CenterHouston, Texas