RecruitingPhase 2NCT07050771

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

Comprehensive Multimodal Prehabilitation Alone or in Combination With Planned Neoadjuvant Therapy in High-risk Patients Prior to Elective Major Cancer Surgery


Sponsor

The Methodist Hospital Research Institute

Enrollment

148 participants

Start Date

Aug 14, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a comprehensive pre-surgery preparation program called Multimodal Prehabilitation (CMMP) — which includes exercise, nutrition, and psychological support — for people who are frail or pre-frail and scheduled for major cancer surgery. Some participants will also receive pre-surgery cancer treatment (chemotherapy or radiation) alongside the program. **You may be eligible if:** - You are 18 or older, in a frail or pre-frail health state - You have confirmed or suspected cancer of the pancreas, bile ducts, ovary, kidney, or bladder - Your cancer is potentially resectable (able to be removed surgically) - You are scheduled for major elective cancer surgery at least 28 days away - You can eat by mouth, walk without a wheelchair, and speak/read English - You have a smartphone or access to one **You may NOT be eligible if:** - You depend on oxygen at rest or with activity - You have serious active heart disease (e.g., recent heart attack or stroke) - You have active brain or bone metastases - You have a significant disability that prevents exercise participation - You cannot eat normally (e.g., fed by tube) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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).


Locations(1)

Houston Methodist Neal Cancer Center

Houston, Texas, United States

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NCT07050771


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