Actively Recruiting
Comprehensive Multimodal Prehabilitation Alone or in Combination With Planned Neoadjuvant Therapy in High-risk Patients Prior to Elective Major Cancer Surgery
Led by The Methodist Hospital Research Institute · Updated on 2026-03-12
148
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of comprehensive multimodal prehabilitation (CMMP) alone or combined with planned neoadjuvant therapy (NAT) in pre-frail or frail patients with probable or confirmed pancreaticobiliary, ovarian, kidney, or bladder cancer before elective major cancer surgery. This phase II, non-randomized trial involves high-risk patients who will undergo major surgeries such as pancreatectomy, cytoreduction, radical nephrectomy, or total cystectomy. The study aims to improve outcomes like postoperative morbidity-free survival, functional fitness, and quality of life. The trial has two groups: one receiving CMMP alone and the other receiving CMMP alongside planned or off-protocol NAT. The CMMP program includes motivational interviewing, nutritional counseling with protein supplementation, inspiratory muscle training, and physical exercises such as aerobic and resistance training. Both groups will undergo at least three weekly cycles of CMMP before surgery, with adherence and safety monitored weekly through electronic systems and staff contact. Following preoperative reassessment, patients will proceed to surgery within 67 days of completing CMMP. Participants will undergo evaluations before and after surgery, including assessments of muscle mass, nutritional status, respiratory function, strength, fitness, performance status, and health-related quality of life. Postoperative follow-up will monitor mortality, morbidity, healthcare use, and quality of life up to 90 days and disease status for up to two years. Blood and tumor tissue samples will be collected to study immune responses and tumor changes related to the interventions. The study will provide insights into the feasibility, safety, and potential benefits of CMMP with or without NAT in these high-risk cancer patients.
CONDITIONS
Brief 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 the time of consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Classified as pre-frail or frail according to 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 and medically fit for elective major cancer surgery.
- Scheduled for specific elective surgeries including pancreatectomy, cytoreduction, radical nephrectomy, or total cystectomy at least 28 days after registration.
- For neoadjuvant therapy group: completed planned neoadjuvant therapy at least 2 weeks before registration.
- For non-neoadjuvant group: medically fit and planned to receive neoadjuvant therapy.
- Able to comply with the intervention and study assessments.
- Willing and able to consume specified protein supplements unless allergic.
- Willing to provide tissue and blood samples.
- Stable anticoagulant regimen if on therapeutic anticoagulation.
- Access to a smartphone.
- Understands, speaks, and reads English.
You will not qualify if you...
- Difficulty or inability to hear and understand loud speech and sounds.
- Unable to eat by mouth (tube feed dependent or on total parenteral nutrition).
- Oxygen dependent at rest or with exertion.
- Significant cardiovascular disease (e.g., NYHA class III or IV, unstable angina, recent heart attack or stroke) within 3 months before trial.
- Dependence on mobility devices other than a cane.
- Active brain metastasis or leptomeningeal disease.
- Active bone metastasis or recent bone fracture.
- Uncontrolled pleural, pericardial effusion, or ascites requiring frequent drainage.
- Planned receipt of investigational therapy other than the study intervention.
- Major surgery within 12 weeks before starting trial treatment preventing compliance.
- Active physical, mental, or personal/social conditions preventing compliance with the intervention or assessments.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - At least 3 weeks
Participants receive the CMMP intervention, which includes motivational interviewing, nutritional prehabilitation, inspiratory muscle training, and physical prehabilitation for at least 3 weeks prior to elective major cancer surgery.
Weekly visits and electronic assessments for adherence and safety
Duration - Within 67 days after last cycle of CMMP
Participants proceed to planned elective major cancer surgery after completing the CMMP intervention.
1 surgery visit (in-person)
Duration - Up to 2 years after surgery
Participants who undergo surgery complete postoperative assessments including mortality/morbidity, healthcare utilization, and quality of life through 90 days post-surgery, with vital and disease status assessments up to 2 years after enrollment.
Multiple visits including assessments at 30, 60, and 90 days postoperatively
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
S
Shondra Word
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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