Actively Recruiting
Comprehensive Multimodal Prehabilitation Alone or With Neoadjuvant Therapy Before Major Cancer Surgery
Led by The Methodist Hospital Research Institute · Updated on 2026-03-12
148
Participants Needed
1
Research Sites
111 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Comprehensive Multimodal Prehabilitation Alone or With Neoadjuvant Therapy Before Major Cancer Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form.
- Age 18 years or older at time of signing informed consent.
- ECOG performance status of 0-2 as assessed by treating cancer surgeon or oncologists.
- Classified as pre-frail or frail based on the Fried Frailty Phenotype.
- Probable or confirmed pancreaticobiliary, ovarian, kidney, or bladder cancer.
- Clinically non-metastatic (stage I-III) or metastatic (stage IV) disease.
- Disease is technically resectable with potential for safe complete tumor removal.
- Planned elective major cancer surgery (pancreatectomy, cytoreduction, nephrectomy, or cystectomy) more than 28 days after registration.
- For neoadjuvant therapy group: completed planned NAT at least 2 weeks before registration.
- For no neoadjuvant therapy group: medically fit and planned to receive NAT.
- Ability to comply with prehabilitation and study assessments.
- Willing and able to consume specified protein supplements without allergy.
- Willing to provide tissue and blood samples.
- Stable anticoagulant regimen if on therapeutic anticoagulation.
- Access to a smartphone personally or via a caregiver.
- Understands, speaks, and reads English.
You will not qualify if you...
- Difficulty hearing or understanding loud speech.
- Unable to eat by mouth (e.g., tube feeding or total parenteral nutrition).
- Oxygen dependent at rest or with exertion.
- Significant cardiovascular disease in the last 3 months (e.g., severe heart failure, unstable angina).
- Dependent on mobility devices other than a cane (e.g., walker, wheelchair).
- Active brain metastasis or leptomeningeal disease.
- Active bone metastasis or recent bone fracture.
- Uncontrolled pleural, pericardial effusion, or ascites requiring frequent drainage (except with indwelling catheters).
- Planned investigational therapy other than CMMP during trial.
- Major surgery within 12 weeks before trial that prevents compliance.
- Active physical, mental, or social conditions preventing compliance with study procedures and interventions.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Houston Methodist Neal Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
D
Darrel Cleere, BSN,RN,CCRP
CONTACT
S
Shondra Word
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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