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Taking people in United StatesPhase 2

Prehabilitation Program Before Major Surgery for Certain Cancers

Tests a multimodal prehabilitation program before surgery in adults with cancer who are frail.

Key facts

Who runs it
The Methodist Hospital Research Institute
Where
Houston, United StatesSee the site
Trial code
Registry title
Comprehensive Multimodal Prehabilitation Alone or With Neoadjuvant Therapy Before Major Cancer Surgery
Status
Recruiting
Phase
Phase 2
People taking part
148 people, planned
Started
14 Aug 2025
Expected to end
1 Oct 2027
Type of study
Interventional, 2 groups
Treatments tested
  • Comprehensive multimodal prehabilitation (CMMP)
Record updated
12 March 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with pancreatic, bile duct, duodenal, ampullary, ovarian, kidney or bladder cancer who are pre-frail or frail and will have major cancer surgery. They get a prehabilitation program before surgery.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Probable or proven pancreaticobiliary/periampullary, ovarian, kidney or bladder cancer, stage I-III or stage IV. The cancer must be removable by surgery. ECOG performance status 0-2. Pre-frail or frail.
Earlier treatment
One group has finished planned neoadjuvant therapy at least 2 weeks before registration. The other group has not had neoadjuvant therapy and plans to receive it.

Main reasons for not taking part

  • Cannot eat by mouth, or needs oxygen
  • Serious heart disease (NYHA class III or IV, unstable angina, heart attack or stroke) in the last 3 months
  • Needs a walker, crutches or wheelchair to walk (a cane is allowed)
  • Active brain metastasis, active bone metastasis or a recent bone fracture
  • Planned investigational therapy other than the prehabilitation program

The registry criteria, word for word

Show all 29 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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
  • 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

Where in United States

  • Houston Methodist Neal Cancer CenterHouston, United StatesContact: Safiya JosephTaking people

About the trial

What the trial wants to find out

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).

The 2 groups in the trial

  • CMMP interventionTreatment being tested

    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.

    Treatment: Comprehensive multimodal prehabilitation (CMMP)

  • Planned neoadjuvant therapy/CMMP interventionTreatment being tested

    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.

    Treatment: Comprehensive multimodal prehabilitation (CMMP)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Comprehensive Multimodal Prehabilitation Alone or in Combination With Planned Neoadjuvant Therapy in High-risk Patients Prior to Elective Major Cancer Surgery
Plain-language title
Prehabilitation Program Before Major Surgery for Certain CancersGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
12 March 2026