RecruitingPhase 2

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

United States148 participantsStarted 2025-08-14

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: 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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of morbidity-free survival

Timeframe: At 30 days postoperatively

Rates of adverse events and serious adverse events

Timeframe: 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 ).

Trial details

NCT IDNCT07050771

SponsorThe Methodist Hospital Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07-01

Contact for this trial

Darrel Cleere, BSN,RN,CCRP

713-441-6232 dwcleere@houstonmethodist.org

View on ClinicalTrials.gov More Hepatopancreaticobiliary (HPB) Malignancy trials