Clinical trial · Interventional
Trimodal Prehabilitation in Pancreatic Cancer Patients Urdergoing Neoadjuvant Treatment
Trimodal Prehabilitation in Pancreatic Cancer Patients Candidate to Neoadjuvant Treatment: A Pilot Study
- 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)
Pancreatic cancer is a disease with a very poor prognosis and less than 10% of these patients live beyond 5 years from diagnosis. Further, it is expected to become the second leading cause of death in the coming years. Today, surgery remains the cornerstone in curing this disease, but the addition of chemotherapy is needed to improve survival. The impact of adjuvant treatment has been previously demonstrated and its efficacy is absolute. However, neoadjuvant chemotherapy (pre-surgery) improves the results after surgery (achieving earlier stages and with better prognosis) and would lead to better survival results. Besides, the moment of cancer diagnosis is a moment of special receptivity to change lifestyles ("teachable moment"). Multimodal prehabilitation includes 1) physical exercise; 2) nutritional and 3) psychological support. The potential advantages of prehabilitation during neoadjuvant therapy would be 1) the possibility of achieving a better physical condition to face surgery; 2) fewer postoperative complications; 3) more likely to receive adjuvant treatment after surgery; 4) better physical function at the end of treatments. To date, most studies have focused on lung and prostate cancer, with a high prevalence of men in the series. This strategy has previously been explored, showing that it is safe and feasible, (Loughney et al). We have not identified any study of trimodal prehabilitation during neoadjuvant treatment and none that has integrated motivational strategies to maintain adherence. Patients during chemotherapy have perceived several adverse effects that could limit adherence to the program. In this regard, a review on the motivation and exercise in cancer survivors shows that it is necessary to apply theoretical frameworks to understand cognitive and motivational processes and develop educational interventions. The self-determination theory is one of the motivational theories most applied today to the analysis of factors related to the adoption of healthy lifestyles. Likewise, patients who are motivated are more likely to improve healthy habits and obtain greater adherence to exercise performance. Therefore, we aimed of carrying out an intervention (pilot study) in ten patients to describe the feasibility of a trimodal prehabilitation program in the hospital environment, applying motivational strategies and a mixed-method (face-to-face and online).
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trimodal prehabilitation | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Training group
- description
- Pancreatic patients will participate in the trimodal prehabilitation: nutrition, psychological and exercise support.
- interventionNames
- Combination Product: Trimodal prehabilitation
Primary outcomes (1)
- measure
- To explore the feasibility of a trimodal prehabilitation program in the hospital setting
- timeFrame
- 1 year
- description
- Adherence to 70% of supervised physical exercise sessions and to nutrition and psychologist sessions
Secondary outcomes (14)
- measure
- Changes in (estimated) cardiorespiratory fitness
- timeFrame
- 3-6 months (from 1st treatment to surgery)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * More than 18 years old * ECOG 0-2 * Being able to complete the mile-time test * Stages I-III * Being able to understand the informed consent * Pancreatic cancer diagnosed Exclusion Criteria: * Metastasic cancer
References
Publications (28)
- BACKGROUNDAlejo LB, Pagola-Aldazabal I, Fiuza-Luces C, Huerga D, de Torres MV, Verdugo AS, Ortega Solano MJ, Felipe JL, Lucia A, Ruiz-Casado A. Exercise prehabilitation program for patients under neoadjuvant treatment for rectal cancer: A pilot study. J Cancer Res Ther. 2019 Jan-Mar;15(1):20-25. doi: 10.4103/jcrt.JCRT_30_17. PMID 30880749
- BACKGROUNDAusania F, Senra P, Melendez R, Caballeiro R, Ouvina R, Casal-Nunez E. Prehabilitation in patients undergoing pancreaticoduodenectomy: a randomized controlled trial. Rev Esp Enferm Dig. 2019 Aug;111(8):603-608. doi: 10.17235/reed.2019.6182/2019. PMID 31232076
- BACKGROUNDBarberan-Garcia A, Ubre M, Roca J, Lacy AM, Burgos F, Risco R, Momblan D, Balust J, Blanco I, Martinez-Palli G. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial. Ann Surg. 2018 Jan;267(1):50-56. doi: 10.1097/SLA.0000000000002293. PMID 28489682
- BACKGROUNDBolshinsky V, Li MH, Ismail H, Burbury K, Riedel B, Heriot A. Multimodal Prehabilitation Programs as a Bundle of Care in Gastrointestinal Cancer Surgery: A Systematic Review. Dis Colon Rectum. 2018 Jan;61(1):124-138. doi: 10.1097/DCR.0000000000000987. PMID 29219922
- BACKGROUNDBundred JR, Kamarajah SK, Hammond JS, Wilson CH, Prentis J, Pandanaboyana S. Prehabilitation prior to surgery for pancreatic cancer: A systematic review. Pancreatology. 2020 Sep;20(6):1243-1250. doi: 10.1016/j.pan.2020.07.411. Epub 2020 Aug 3. PMID 32826168
- BACKGROUNDCarli F, Silver JK, Feldman LS, McKee A, Gilman S, Gillis C, Scheede-Bergdahl C, Gamsa A, Stout N, Hirsch B. Surgical Prehabilitation in Patients with Cancer: State-of-the-Science and Recommendations for Future Research from a Panel of Subject Matter Experts. Phys Med Rehabil Clin N Am. 2017 Feb;28(1):49-64. doi: 10.1016/j.pmr.2016.09.002. PMID 27913000