Trimodal Prehabilitation in Pancreatic Cancer Patients Urdergoing Neoadjuvant Treatment (PREPANC)

May 29, 2025 updated by: Ana Ruiz-Casado, Puerta de Hierro University Hospital

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.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro Majadahonda

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Training group
Pancreatic patients will participate in the trimodal prehabilitation: nutrition, psychological and exercise support.
Combination product: Trimodal prehabilitation
Pancreatic cancer patients (not stage 4) will undergo trimodal prehabilitation: nutrition, psychological, and exercise support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To explore the feasibility of a trimodal prehabilitation program in the hospital setting
Time Frame: 1 year
Adherence to 70% of supervised physical exercise sessions and to nutrition and psychologist sessions
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in (estimated) cardiorespiratory fitness
Time Frame: 3-6 months (from 1st treatment to surgery)
Mile-time test
3-6 months (from 1st treatment to surgery)
Changes in muscle strength
Time Frame: 3-6 months (from 1st treatment to surgery)
Handgrip by dynamometry
3-6 months (from 1st treatment to surgery)
Changes in body mass index
Time Frame: 3-6 months (from 1st treatment to surgery)
BMI (Body Mass Index kg/sm)
3-6 months (from 1st treatment to surgery)
Changes in body composition
Time Frame: 3-6 months (from 1st treatment to surgery)
waist, hip, calf circumferences
3-6 months (from 1st treatment to surgery)
Changes in levels of physical activity at week
Time Frame: 3-6 months (from 1st treatment to surgery)
Accelerometry
3-6 months (from 1st treatment to surgery)
Changes in quality of life
Time Frame: 3-6 months (from before1st treatment to surgery)
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.
3-6 months (from before1st treatment to surgery)
Describe changes in fatigue levels
Time Frame: 3-6 months (from before 1st treatment to surgery)
PERFORM (Multidimensional scale 12-60. The higher the less fatigue)
3-6 months (from before 1st treatment to surgery)
Dose intensity in neoadjuvant treatment
Time Frame: 3-6 months (from 1st treatment to surgery)
percentage of intended doses that are administered in the due time
3-6 months (from 1st treatment to surgery)
Describe post-surgical complications
Time Frame: three months
Surgical wound and pancreatic fistula
three months
Nutritional status
Time Frame: 3-6 months (from 1st treatment to surgery)
body mass index
3-6 months (from 1st treatment to surgery)
Percentage of pathological complete responses
Time Frame: 4-6 weeks after surgery
Percentage of patients with no viable cells in the surgical specimen
4-6 weeks after surgery
Percentage of patients receiving adjuvant therapy
Time Frame: Three months after surgery
Patients that received at least two cycles after surgery
Three months after surgery
Hindrances and facilitators of patients
Time Frame: During the prehabilitation program (3-6 months for each patient)
Qualitative methods. semi-structured interviews and observation
During the prehabilitation program (3-6 months for each patient)
Anxiety and depression
Time Frame: 3-6 months (from 1st treatment to surgery)
Hospital Anxiety and Depression Scale questionnaire. Values 8-21. The higher the worse
3-6 months (from 1st treatment to surgery)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Circulating tumor DNA and mutational variations
Time Frame: before initiating chemotherapy
circulant tumor DNA
before initiating chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Puerta de Hierro University Hospital

Investigators

  • Principal Investigator: Ana Ruiz-Casado, MD, HU Puerta de Hierro Majadahonda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2022

Primary Completion (Actual)

December 2, 2024

Study Completion (Actual)

May 9, 2025

Study Registration Dates

First Submitted

March 14, 2022

First Submitted That Met QC Criteria

January 31, 2023

First Posted (Actual)

February 10, 2023

Study Record Updates

Last Update Posted (Actual)

June 4, 2025

Last Update Submitted That Met QC Criteria

May 29, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PH-UMH02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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