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NCT07050771RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 12 Mar 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
148 (estimated)
First submitted
7 May 2025
Start date
14 Aug 2025
Primary completion date
1 Jul 2027
Lead sponsor
The Methodist Hospital Research Institute
NCT number
NCT07050771

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 148
  • From 14 Aug 2025 to the primary completion date, 1 Jul 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • 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.

Other illness

  • Active brain metastasis or leptomeningeal disease.
  • 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.

Other

  • 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).
  • Dependence on mobility device for ambulation other than a cane (e.g., crutches, walker, wheelchair).
  • 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

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Houston Methodist Neal Cancer Center
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.