About this trial
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).
Eligibility criteria
Qualifiers
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 the Fried Frailty Phenotype
Disqualifiers
Difficulty or inability to hear and/or understand loud speech and sounds.
Unable to eat by mouth (e.g., tube feed dependent, on total parenteral nutrition, etc.)
Oxygen dependent (or rest and/or with exertion).
Significant cardiovascular disease (such as New York Heart Association (NYHA) Functional Classification III or IV, unstable angina, unstable arrhythmia, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of trial treatment.
Trial design
Treatments tested in this trial
- Comprehensive multimodal prehabilitation (CMMP)