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Pancreatic NeoplasmsPREPANCNCT05722223

Trimodal Prehabilitation in Pancreatic Cancer Patients Urdergoing Neoadjuvant Treatment

A study testing Trimodal prehabilitation in people with Pancreatic Neoplasms, run by Puerta de Hierro University Hospital at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Neoplasms
What is being tested?
Trimodal prehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteSpain
Study dates
15 Mar 2022to 9 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Metastasic cancer

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222

Other trials in Spain

About this study

Official title: Trimodal Prehabilitation in Pancreatic Cancer Patients Candidate to Neoadjuvant Treatment: A Pilot Study

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.

Read more

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).

Read the detailed description

outcome measures refer to feasibility of the intervention:

Recruitment Attendance to the training sessions Attendance to psychologist and nutritionist sessions

And also to physical condition Cardiorespiratory fitness Muscular strength Body composition Physical activity Quality of life Fatigue score

Being tested
Trimodal prehabilitation
Keywords
exercise, pancreatic, cancer, trimodal
Medical subject headings
Pancreatic Neoplasms, Motor Activity, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trimodal prehabilitationCombination product

    Pancreatic cancer patients (not stage 4) will undergo trimodal prehabilitation: nutrition, psychological, and exercise support.

Study groups in NCT05722223
Study groupRoleWhat they receive
Training groupExperimentalPancreatic patients will participate in the trimodal prehabilitation: nutrition, psychological and exercise support.
Receives: Combination Product: Trimodal prehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To explore the feasibility of a trimodal prehabilitation program in the hospital setting

    Adherence to 70% of supervised physical exercise sessions and to nutrition and psychologist sessions

    Measured: 1 year

Secondary outcomes (14)
  1. Changes in (estimated) cardiorespiratory fitness

    Mile-time test

    Measured: 3-6 months (from 1st treatment to surgery)

  2. Changes in muscle strength

    Handgrip by dynamometry

    Measured: 3-6 months (from 1st treatment to surgery)

  3. Changes in body mass index

    BMI (Body Mass Index kg/sm)

    Measured: 3-6 months (from 1st treatment to surgery)

  4. Changes in body composition

    waist, hip, calf circumferences

    Measured: 3-6 months (from 1st treatment to surgery)

  5. Changes in levels of physical activity at week

    Accelerometry

    Measured: 3-6 months (from 1st treatment to surgery)

  6. Changes in quality of life

    EORTC-QLQ-C30 (European Organization for Research and Treatment of Cancer. Quality of Life questionnaire. C30. all scores of the QLQ-C30 were transformed linearly so that all scales ranged from 0 to 100. In the function scales higher scores represent a better level of functioning while in the case of symptom scales/items higher scores mark a higher level of symptomatology or problems.

    Measured: 3-6 months (from before1st treatment to surgery)

  7. Describe changes in fatigue levels

    PERFORM (Multidimensional scale 12-60. The higher the less fatigue)

    Measured: 3-6 months (from before 1st treatment to surgery)

  8. Dose intensity in neoadjuvant treatment

    percentage of intended doses that are administered in the due time

    Measured: 3-6 months (from 1st treatment to surgery)

  9. Describe post-surgical complications

    Surgical wound and pancreatic fistula

    Measured: three months

  10. Nutritional status

    body mass index

    Measured: 3-6 months (from 1st treatment to surgery)

  11. Percentage of pathological complete responses

    Percentage of patients with no viable cells in the surgical specimen

    Measured: 4-6 weeks after surgery

  12. Percentage of patients receiving adjuvant therapy

    Patients that received at least two cycles after surgery

    Measured: Three months after surgery

  13. Hindrances and facilitators of patients

    Qualitative methods. semi-structured interviews and observation

    Measured: During the prehabilitation program (3-6 months for each patient)

  14. Anxiety and depression

    Hospital Anxiety and Depression Scale questionnaire. Values 8-21. The higher the worse

    Measured: 3-6 months (from 1st treatment to surgery)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2023
  2. Study start15 Mar 2022
  3. Primary completion2 Dec 2024
  4. Study completion9 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
All the participants will receive trimodal prehabilitation. Only one arm
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05722223
Sponsor's protocol ID
PH-UMH02
Acronym
PREPANC
Status last verified
May 2025
First submitted
14 Mar 2022
Last updated
4 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Alejo 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.

    PubMed 30880749
  • Ausania 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.

    PubMed 31232076
  • Barberan-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.

    PubMed 28489682
  • Bolshinsky 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.

    PubMed 29219922
  • Bundred 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.

    PubMed 32826168
  • Carli 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.

    PubMed 27913000
  • Chandrabalan VV, McMillan DC, Carter R, Kinsella J, McKay CJ, Carter CR, Dickson EJ. Pre-operative cardiopulmonary exercise testing predicts adverse post-operative events and non-progression to adjuvant therapy after major pancreatic surgery. HPB (Oxford). 2013 Nov;15(11):899-907. doi: 10.1111/hpb.12060. Epub 2013 Feb 20.

    PubMed 23458160
  • Djarv T, Metcalfe C, Avery KN, Lagergren P, Blazeby JM. Prognostic value of changes in health-related quality of life scores during curative treatment for esophagogastric cancer. J Clin Oncol. 2010 Apr 1;28(10):1666-70. doi: 10.1200/JCO.2009.23.5143. Epub 2010 Mar 1.

    PubMed 20194863
  • Florez Bedoya CA, Cardoso ACF, Parker N, Ngo-Huang A, Petzel MQ, Kim MP, Fogelman D, Romero SG, Wang H, Park M, Katz MHG, Schadler KL. Exercise during preoperative therapy increases tumor vascularity in pancreatic tumor patients. Sci Rep. 2019 Sep 27;9(1):13966. doi: 10.1038/s41598-019-49582-3.

    PubMed 31562341
  • González-Cutre D, Sicilia A, Sierra AC et al. Understanding the need for novelty from the perspective of self-determination theory. Personality and Individual Differences 2016; 102:159-169

  • Gruber ES, Jomrich G, Kaider A, Gnant M, Sahora K, Schindl M. The Prognostic Index Independently Predicts Survival in Patients with Pancreatic Ductal Adenocarcinoma Undergoing Resection. Ann Surg Oncol. 2020 Jun;27(6):2017-2024. doi: 10.1245/s10434-019-08161-6. Epub 2020 Jan 3.

    PubMed 31900809
  • Jie B, Jiang ZM, Nolan MT, Zhu SN, Yu K, Kondrup J. Impact of preoperative nutritional support on clinical outcome in abdominal surgical patients at nutritional risk. Nutrition. 2012 Oct;28(10):1022-7. doi: 10.1016/j.nut.2012.01.017. Epub 2012 Jun 5.

    PubMed 22673593
  • Jones LW, Peddle CJ, Eves ND, Haykowsky MJ, Courneya KS, Mackey JR, Joy AA, Kumar V, Winton TW, Reiman T. Effects of presurgical exercise training on cardiorespiratory fitness among patients undergoing thoracic surgery for malignant lung lesions. Cancer. 2007 Aug 1;110(3):590-8. doi: 10.1002/cncr.22830.

    PubMed 17582629
  • Jones LW, Eves ND, Haykowsky M, Joy AA, Douglas PS. Cardiorespiratory exercise testing in clinical oncology research: systematic review and practice recommendations. Lancet Oncol. 2008 Aug;9(8):757-65. doi: 10.1016/S1470-2045(08)70195-5.

    PubMed 18672211
  • Kodama S, Saito K, Tanaka S, Maki M, Yachi Y, Asumi M, Sugawara A, Totsuka K, Shimano H, Ohashi Y, Yamada N, Sone H. Cardiorespiratory fitness as a quantitative predictor of all-cause mortality and cardiovascular events in healthy men and women: a meta-analysis. JAMA. 2009 May 20;301(19):2024-35. doi: 10.1001/jama.2009.681.

    PubMed 19454641

Questions about this trial

What is this clinical trial studying?

A study testing Trimodal prehabilitation in people with Pancreatic Neoplasms, run by Puerta de Hierro University Hospital at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To explore the feasibility of a trimodal prehabilitation program in the hospital setting (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05722223, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.

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