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New treatment option for Hepatopancreaticobiliary (HPB) Malignancy
Official title Comprehensive Multimodal Prehabilitation Alone or With Neoadjuvant Therapy Before Major Cancer Surgery
ClinicalTrials.gov ID: NCT07050771
What this study is testing
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients are eligible for entry into the study (First Registration) only if ALL of the following criteria apply. No exceptions or waivers will be...
- 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...
- Pre-frail or frail (based on the Fried Frailty Phenotype
You likely can't join if
- Patients are NOT eligible for entry into the study (First Registration) only ANY of the following criteria apply. No exceptions or waivers will be...
- 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).
- Significant cardiovascular disease (such as New York Heart Association (NYHA) Functional Classification III or IV, unstable angina, unstable...
- Dependence on mobility device for ambulation other than a cane (e.g., crutches, walker, wheelchair).
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- Tentatively scheduled to undergo elective pancreatectomy (open or minimally invasive pancreaticoduodenectomy or open distal pancreatectomy) for pancreaticobiliary/periampullary cancer, elective surgical cytoreduction...
- 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...
- 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.
What rules you out
- 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).
- 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...
- Dependence on mobility device for ambulation other than a cane (e.g., crutches, walker, wheelchair).
- Active brain metastasis or leptomeningeal disease.
- 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
- 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 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.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.