Comprehensive Multimodal Prehabilitation Alone or With Neoadjuvant Therapy Before Major Cancer Surgery

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Methodist Hospital Research Institute

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)

Treatment groups

148 Participants
are divided into 2 treatment groups