Trimodal Prehabilitation in Pancreatic Cancer Patients Urdergoing Neoadjuvant Treatment

NCT ID: NCT05722223

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-15
• Study Completion Date: 2025-05-09

Brief 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. 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).

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

Conditions

Pancreatic Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Training group

Pancreatic patients will participate in the trimodal prehabilitation: nutrition, psychological and exercise support.

Group Type: EXPERIMENTAL

Trimodal prehabilitation

Intervention Type: COMBINATION_PRODUCT

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

Interventions

Trimodal prehabilitation

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

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Puerta de Hierro University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ana Ruiz-Casado

Medical oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ana Ruiz-Casado, MD

Role: PRINCIPAL_INVESTIGATOR

HU Puerta de Hierro Majadahonda

Locations

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, Spain

Countries

Spain

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Other Identifiers

PH-UMH02

Identifier Type: -

Identifier Source: org_study_id