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

NCT07050771 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2026-03-12

No results posted yet for this study

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).

Conditions

  • Hepatopancreaticobiliary (HPB) Malignancy
  • Ovarian Cancer (OvCa)
  • Kidney Cancers
  • Bladder Cancer

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).

Sponsors & Collaborators

  • The Methodist Hospital Research Institute

    lead OTHER

Principal Investigators

  • Nestor Esnaola, M.D. · Houston Methodist Neal Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-14
Primary Completion
2027-07-01
Completion
2027-10-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07050771 on ClinicalTrials.gov