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Trial Title:
Trimodal Prehabilitation in Pancreatic Cancer Patients Urdergoing Neoadjuvant Treatment
NCT ID:
NCT05722223
Condition:
Pancreatic Neoplasms
Conditions: Official terms:
Pancreatic Neoplasms
Conditions: Keywords:
exercise
pancreatic
cancer
trimodal
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
All the participants will receive trimodal prehabilitation. Only one arm
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Combination Product
Intervention name:
Trimodal prehabilitation
Description:
Pancreatic cancer patients (not stage 4) will undergo trimodal prehabilitation:
nutrition, psychological, and exercise support.
Arm group label:
Training group
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
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital Universitario Puerta de Hierro Majadahonda
Address:
City:
Majadahonda
Zip:
28222
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Maria Romero Elias, PhD
Email:
remaria17@gmail.com
Contact backup:
Last name:
Ana Ruiz Casado, MD PhD
Email:
arcasado@salud.madrid.org
Start date:
March 15, 2022
Completion date:
August 20, 2024
Lead sponsor:
Agency:
Puerta de Hierro University Hospital
Agency class:
Other
Source:
Puerta de Hierro University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05722223
