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Prehabilitation for Major Cancer Surgery

This study is looking at how a program called Comprehensive Multimodal Prehabilitation (CMMP) can help people preparing for major cancer surgery. CMMP includes things like motivational interviewing, nutrition support, breathing exercises, and physical activity. We want to see if CMMP by itself, or combined with standard neoadjuvant therapy (treatment given before surgery), can improve how well you recover after surgery and reduce problems. This study is for adults aged 18 and older who have certain types of cancer, including hepatopancreaticobiliary (HPB) malignancy, ovarian cancer, kidney cancers, or bladder cancer, and are considered at higher risk for complications. We are looking for 148 participants in total. The study will measure how many people recover without complications 30 days after surgery and track any side effects.

Study design
This is a Phase II study with two groups, but participants are not randomly assigned. Approximately 148 participants will be enrolled.
What's involved
The Comprehensive Multimodal Prehabilitation (CMMP) intervention will be administered for at least 3 weeks, including two 10-15 minute motivational interviewing sessions. You will be followed for adverse events until your preoperative re-evaluation, which is about 1 to 3 months after joining.
Compensation
Not stated in the trial record.
Follow-up
Your health will be monitored for morbidity-free survival at 30 days after surgery. Adverse events will be tracked from enrollment until your planned preoperative re-evaluation.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07050771

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
The Methodist Hospital Research Institute
~148 participants
Updated 2026-03-12 on ClinicalTrials.gov
What's tested:Comprehensive multimodal prehabilitation (CMMP)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of morbidity-free survival
Measured over At 30 days postoperatively
+1 more outcome measured

Conditions

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

Explore related trials

Ampullary CancerBladder CarcinomaCholangiocarcinomaDuodenal CarcinomaKidney CarcinomaMalignant Ovarian NeoplasmPancreatic CarcinomaSolid Neoplasm

Where it's being run

1 sites across 1 states
Texas1

Study leadership

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

Who to contact

Darrel Cleere, BSN,RN,CCRP
[email protected]
713-441-6232
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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.
Access to a smart phone (personally or via caretaker who resides with the patient).
Understands, speaks, and reads English.

Exclusion

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.

What this trial measures

  • Rate of morbidity-free survivalAt 30 days postoperatively

    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.

  • Rates of adverse events and serious adverse eventsFrom 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 ).

    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.