Trimodal Prehabilitation in Pancreatic Cancer Patients Urdergoing Neoadjuvant Treatment

NCT05722223 | Completed

• 1 other identifier: PH-UMH02
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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).

Conditions

Pancreatic Neoplasms

Keywords

exercise; pancreatic; cancer; trimodal

Outcome Measures

Primary Outcomes (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

  1 year

Secondary Outcomes (14)

• Changes in (estimated) cardiorespiratory fitness

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

• Changes in muscle strength

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

• Changes in body mass index

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

• Changes in body composition

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

• Changes in levels of physical activity at week

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

Other Outcomes (1)

• Circulating tumor DNA and mutational variations

  before initiating chemotherapy

Study Arms (1)

Training group

EXPERIMENTAL

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

Combination Product: Trimodal prehabilitation

Interventions

Trimodal prehabilitation COMBINATION_PRODUCT

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

Training group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Metastasic cancer

Sponsors & Collaborators

• Puerta de Hierro University Hospital: lead

Study Sites (1)

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, 28222, Spain

Location

Related Publications (28)

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MeSH Terms

Conditions

Pancreatic Neoplasms; Motor Activity; Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Behavior

Study Officials

• Ana Ruiz-Casado, MD

  HU Puerta de Hierro Majadahonda

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical oncologist

Model Details: All the participants will receive trimodal prehabilitation. Only one arm

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: February 10, 2023
• Study Start: March 15, 2022
• Primary Completion: December 2, 2024
• Study Completion: May 9, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-05

Locations

ES (1)