Clinical trial NCT05722223: Trimodal Prehabilitation in Pancreatic Cancer Patients Urdergoing Neoadjuvant Treatment
Official title: Trimodal Prehabilitation in Pancreatic Cancer Patients Candidate to Neoadjuvant Treatment: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Neoplasms
Keywords: exercise
pancreatic
cancer
trimodal
Lead sponsor: Puerta de Hierro University Hospital
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All the participants will receive trimodal prehabilitation. Only one arm
Primary purpose: SUPPORTIVE_CARE

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

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

Primary outcomes:
measure: To explore the feasibility of a trimodal prehabilitation program in the hospital setting
timeFrame: 1 year
Secondary outcomes:
measure: Changes in (estimated) cardiorespiratory fitness
timeFrame: 3-6 months (from 1st treatment to surgery)
measure: Changes in muscle strength
timeFrame: 3-6 months (from 1st treatment to surgery)
measure: Changes in body mass index
timeFrame: 3-6 months (from 1st treatment to surgery)
measure: Changes in body composition
timeFrame: 3-6 months (from 1st treatment to surgery)
measure: Changes in levels of physical activity at week
timeFrame: 3-6 months (from 1st treatment to surgery)
measure: Changes in quality of life
timeFrame: 3-6 months (from before1st treatment to surgery)
measure: Describe changes in fatigue levels
timeFrame: 3-6 months (from before 1st treatment to surgery)
measure: Dose intensity in neoadjuvant treatment
timeFrame: 3-6 months (from 1st treatment to surgery)
measure: Describe post-surgical complications
timeFrame: three months
measure: Nutritional status
timeFrame: 3-6 months (from 1st treatment to surgery)
measure: Percentage of pathological complete responses
timeFrame: 4-6 weeks after surgery
measure: Percentage of patients receiving adjuvant therapy
timeFrame: Three months after surgery
measure: Hindrances and facilitators of patients
timeFrame: During the prehabilitation program (3-6 months for each patient)
measure: Anxiety and depression
timeFrame: 3-6 months (from 1st treatment to surgery)
Other outcomes:
measure: Circulating tumor DNA and mutational variations
timeFrame: before initiating chemotherapy
Locations:
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid
Study officials:
affiliation: HU Puerta de Hierro Majadahonda
name: Ana Ruiz-Casado, MD
role: PRINCIPAL_INVESTIGATOR
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