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RECRUITING
NCT07050771
PHASE2

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

Sponsor: The Methodist Hospital Research Institute

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

148

Start Date

2025-08-14

Completion Date

2027-10-01

Last Updated

2026-03-12

Healthy Volunteers

No

Interventions

OTHER

Comprehensive 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