Clinical trial · Interventional
Multidimensional Prehabilitation in Pancreatic Surgery for Pancreatic and Periampullary Neoplasms
Randomized Clinical Trial Investigating Multidimensional Prehabilitation in Pancreatic Surgery for Patients With Pancreatic and Periampullary Neoplasms
NCT05225038CI-TRIAL-00080854completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Randomized Clinical Trial Investigating Multidimensional Prehabilitation in Pancreatic Surgery for participants with Pancreatic and Periampullary Neoplasms
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Periampullary Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Behavioral Medicine | Behavioral | — | UNRESOLVED |
| Exercise | Other | — | UNRESOLVED |
| Nutritional | Dietary Supplement | — | UNRESOLVED |
| Smoking Cessation | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control Arm (Standard of Care)
- description
- Participants will receive the current standard preoperative education and counseling. Participants will receive information regarding exercise and nutrition from a member of the surgical team. Participants will meet with a behavioral medicine specialist for additional education regarding factors affecting postoperative stress and relaxation techniques. Participants who are actively smoking will be counseled regarding smoking cessation and offered a referral to smoking cessation resources.
- interventionNames
- Behavioral: Behavioral Medicine
- Behavioral: Smoking Cessation
- type
- EXPERIMENTAL
- label
- Intervention Arm (Prehabilitation)
- description
- Participants in the intervention arm will receive all of the standard of care, as listed above, as well as individualized exercise and nutritional prehabilitation regimens. During the data analysis, participants will be subdivided into treatment groups, upfront surgical resection versus neoadjuvant chemotherapy, in order to determine whether length of prehabilitation affected outcomes and distinguish any possible effect of chemotherapy toxicity.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants \> 18 years old with ECOG performance status 0-2 and ASA score ≤3 * Requiring pancreatic resection for diagnosed or suspected pancreatic and periampullary neoplasms * Surgery scheduled at least 2 weeks after the initial surgical evaluation * Fluency in English * Willingness to answer questionnaires, complete daily exercise \& nutrition log, as well as participate in follow-up telephone calls * Screening: Physical Activity Readiness - Questionnaire (PAR-Q+) * PAR-Q+ assesses participants comorbidities and symptoms with current activities. If participants answer "yes" to any of the screening questions, they will need to complete additional questions regarding their chronic medical conditions including, but not limited to, heart disease, stroke, diabetes, depression/anxiety, and COPD/asthma, to determine their ability to participate in physical activity. Exclusion Criteria: * Screening: Physical Activity Readiness - Questionnaire (PAR-Q+) * Participants with concurrent medical conditions that prohibit exercise, such as those who indicate on the questionnaire that they experience chest pain, dizziness, or loss of consciousness with physical activity; those with chest pain at rest; or those with bone/joint/soft tissue conditions that could worsen with physical activity. Participants with specific comorbidities, such as coronary artery disease. congestive heart failure, or uncontrolled asthma/COPD, that may prevent participation will also be excluded. * Inability to provide own informed consent * Inability to read or verbally understand questionnaires in English * Impaired hearing that creates a barrier for telephone follow-up * Visual deficit that would cause exercise to be hazardous * Emergent or urgent surgeries
References
Publications (0)
Data not yet available
No reference posted for this study.