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

NCT07050771 | Recruiting Phase 2 DMC

• 1 other identifier: Pro00039923
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Rate of morbidity-free survival

  Percentage of patients alive without any postoperative complications (as defined by the American College of Surgeons National Surgical Quality Improvement Program {ACS NSQIP\]) in each study arm.

  At 30 days postoperatively

• Rates of adverse events and serious adverse events

  Percentage of patients with adverse events and serious adverse events (AEs/SAEs; as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] v5.0) during receipt of CMMP in each study arm.

  From study enrollment to the time of planned, off-protocol, preoperative re-evaluation by the participant's primary cancer surgeon (approximately 1 month after enrollment in Arm 1 and 2-3 months after enrollment in Arm 2 ).

Secondary Outcomes (10)

• Rate of improvement in preoperative functional status/fitness

  At the time of planned, off-protocol, preoperative re-evaluation by the participant's primary cancer surgeon (approximately 1 month after enrollment in Arm 1 and 2-3 months after enrollment in Arm 2).

• Rate of completion of planned preoperative therapy

  At the time of planned, off-protocol, preoperative re-evaluation by the participant's primary cancer surgeon (approximately 1 month after enrollment in Arm 1 and 2-3 months after enrollment in Arm 2).

• Health-related quality of life (HRQOL)

  At the time of planned, off-protocol, preoperative re-evaluation by the participant's primary cancer surgeon (approximately 1 month after enrollment in Arm 1 and 2-3 months after enrollment in Arm 2) and at 30, 60, and 90 days postoperatively.

• Postoperative rate of receipt of intended oncologic therapy (RIOT)

  At 30, 60, and 90 days postoperatively

• Rate of postoperative pulmonary complications (PPCs)

  At 30 days postoperatively

Study Arms (2)

CMMP intervention

EXPERIMENTAL

Participants will receive the CMMP intervention, which includes motivational interviewing, nutritional prehabilitation (nutritional assessment/counseling and protein supplementation), inspiratory muscle training, and physical prehabilitation (aerobic and strength/resistance training) for at least 3 weeks prior to elective major cancer surgery.

Other: Comprehensive multimodal prehabilitation (CMMP)

Planned neoadjuvant therapy/CMMP intervention

EXPERIMENTAL

Participants will receive the CMMP intervention (in conjunction with planned, off-protocol neoadjuvant therapy), which includes motivational interviewing, nutritional prehabilitation (nutritional assessment/counseling and protein supplementation), inspiratory muscle training, and physical prehabilitation (aerobic and strength/resistance training) for at least 3 weeks prior to elective major cancer surgery.

Other: Comprehensive multimodal prehabilitation (CMMP)

Interventions

Comprehensive multimodal prehabilitation (CMMP) OTHER

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).

CMMP intervention; Planned neoadjuvant therapy/CMMP intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients are eligible for entry into the study (First Registration) only if ALL of the following criteria apply. No exceptions or waivers will be granted for patients who do not meet the eligibility criteria.
• 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
• Probable or proven (histologically confirmed) pancreaticobiliary/periampullary (i.e., pancreatic cancer, cholangiocarcinoma, duodenal cancer, or ampullary cancer), ovarian cancer, kidney cancer, or bladder cancer based on central pathological review at Houston Methodist Hospital.
• Clinically non-metastatic (stage I-III) or metastatic (IV) disease.
• Technically resectable disease (no significant vascular, neural, or bony involvement and potential to safely achieve R0 resection) and potentially medically fit for EMCS per the treating cancer surgeon (surgical oncologist/HBP surgeon, gynecologic oncologist, or urologic oncologist).
• Tentatively scheduled to undergo elective pancreatectomy (open or minimally invasive pancreaticoduodenectomy or open distal pancreatectomy) for pancreaticobiliary/periampullary cancer, elective surgical cytoreduction for ovarian cancer, elective open radical nephrectomy for kidney cancer, or elective (open or minimally invasive) total cystectomy for bladder cancer by one of the study MPI or Co-Is \> 28 days after trial registration.
• Neoadjuvant therapy group only: Completed planned NAT (if any) at least 2 weeks prior to Study Registration.
• No neoadjuvant therapy group only: Medically fit and planned to receive NAT per the treating medical and/or radiation oncologist.
• Ability to comply with the CMMP intervention and study assessments as per protocol, in the MPI's judgment.
• Willing and able to consume a lactose-free, whey protein supplement (if not allergic to milk protein/soy and no history of galactosemia), marine protein supplement (if not allergic to marine protein/shellfish), or pea protein supplement (if not allergic to pea protein).
• Willing to provide tissue and blood specimens as per protocol.
• For patients receiving therapeutic anticoagulation: stable anticoagulant regimen.

You may not qualify if:

• Patients are NOT eligible for entry into the study (First Registration) only ANY of the following criteria apply. No exceptions or waivers will be granted for patients who do not meet the eligibility criteria.
• 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.
• Dependence on mobility device for ambulation other than a cane (e.g., crutches, walker, wheelchair).
• Active brain metastasis or leptomeningeal disease.
• Active bone metastasis and/or recent bone fracture.
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). NOTE: Patients with indwelling catheters (e.g., PleurX) are allowed
• Planned receipt of investigational therapy/treatment (other than the protocol-mandated CMMP intervention) during the trial treatment.
• Major procedure/surgery within 12 weeks prior to initiation of trial treatment that would prevent the patient from complying with the CMMP intervention and study assessments as per protocol, in the MPI's judgment.
• Active physical/mental condition or personal/social circumstance that would prevent the patient from complying with the CMMP intervention and study assessments as per protocol, in the MPI's judgment.

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Neal Cancer Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms; Ovarian Neoplasms; Kidney Neoplasms; Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Urologic Neoplasms; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Urinary Bladder Diseases

Study Officials

• Nestor Esnaola, M.D.

  Houston Methodist Neal Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Darrel Cleere, BSN,RN,CCRP

CONTACT

713-441-6232; dwcleere@houstonmethodist.org

Shondra Word

CONTACT

713-441-5122; sword@houstonmethodist.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Model Details: Participants are assigned to receive the pre-surgery CMMP only or CMMP with neoadjuvant therapy, based on their cancer characteristics and clinical needs. The CMMP consists of at least 3 weeks of therapy (nutritional supplements, exercise, and motivational interviewing). After surgery, 30-day morbidity-free survival will be determined and compared to historical controls.

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: July 3, 2025
• Study Start: August 14, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: After publication of primary study outcomes
• Access Criteria: Other investigators; via an emailed and approved proposal that describes planned analyses and a signed data sharing agreement.

Locations

US (1)