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Completed

NCT Number: NCT05722223

Trimodal Prehabilitation in Pancreatic Cancer Patients Urdergoing Neoadjuvant Treatment

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, 28222, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TRIMODAL PREHABILITATION

Combination Product

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Changes in (estimated) cardiorespiratory fitness

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

    Mile-time test

  2. Changes in muscle strength

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

    Handgrip by dynamometry

  3. Changes in body mass index

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

    BMI (Body Mass Index kg/sm)

  4. Changes in body composition

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

    waist, hip, calf circumferences

  5. Changes in levels of physical activity at week

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

    Accelerometry

  6. 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.

  7. 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)

  8. 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

  9. Describe post-surgical complications

    Time frame: three months

    Surgical wound and pancreatic fistula

  10. Nutritional status

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

    body mass index

  11. Percentage of pathological complete responses

    Time frame: 4-6 weeks after surgery

    Percentage of patients with no viable cells in the surgical specimen

  12. Percentage of patients receiving adjuvant therapy

    Time frame: Three months after surgery

    Patients that received at least two cycles after surgery

  13. Hindrances and facilitators of patients

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

    Qualitative methods. semi-structured interviews and observation

  14. 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

Other outcomes

  1. Circulating tumor DNA and mutational variations

    Time frame: before initiating chemotherapy

    circulant tumor DNA

Sponsors and collaborators

Lead sponsor

Puerta de Hierro University Hospital

Other

Registry information

Official study title

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

Acronym: PREPANC

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Feb 10, 2023
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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