Study of Multimodal Prehabilitation With or Without Planned Neoadjuvant Therapy Before Major Surgery in High-Risk Patients With Pancreaticobiliary, Ovarian, Kidney, or Bladder Cancer

What this Trial Is About

Researchers are evaluating the effectiveness and safety of comprehensive multimodal prehabilitation CMMP alone or combined with planned neoadjuvant therapy NAT in pre-frail or frail patients with probable or confirmed pancreaticobiliary, ovarian, kidney, or bladder cancer before elective major cancer surgery. This phase II, non-randomized trial involves high-risk patients who will undergo major surgeries such as pancreatectomy, cytoreduction, radical nephrectomy, or total cystectomy. The study aims to improve outcomes like postoperative morbidity-free survival, functional fitness, and quality of life. The trial has two groups one receiving CMMP alone and the other receiving CMMP alongside planned or off-protocol NAT. The CMMP program includes motivational interviewing, nutritional counseling with protein supplementation, inspiratory muscle training, and physical exercises such as aerobic and resistance training. Both groups will undergo at least three weekly cycles of CMMP before surgery, with adherence and safety monitored weekly through electronic systems and staff contact. Following preoperative reassessment, patients will proceed to surgery within 67 days of completing CMMP. Participants will undergo evaluations before and after surgery, including assessments of muscle mass, nutritional status, respiratory function, strength, fitness, performance status, and health-related quality of life. Postoperative follow-up will monitor mortality, morbidity, healthcare use, and quality of life up to 90 days and disease status for up to two years. Blood and tumor tissue samples will be collected to study immune responses and tumor changes related to the interventions. The study will provide insights into the feasibility, safety, and potential benefits of CMMP with or without NAT in these high-risk cancer patients.

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