Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222, Spain
NCT Number: NCT05722223
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).
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Majadahonda, Madrid, 28222, Spain
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pancreatic cancer patients (not stage 4) will undergo trimodal prehabilitation: nutrition, psychological, and exercise support.
Time frame: 1 year
Adherence to 70% of supervised physical exercise sessions and to nutrition and psychologist sessions
Time frame: 3-6 months (from 1st treatment to surgery)
Mile-time test
Time frame: 3-6 months (from 1st treatment to surgery)
Handgrip by dynamometry
Time frame: 3-6 months (from 1st treatment to surgery)
BMI (Body Mass Index kg/sm)
Time frame: 3-6 months (from 1st treatment to surgery)
waist, hip, calf circumferences
Time frame: 3-6 months (from 1st treatment to surgery)
Accelerometry
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.
Time frame: 3-6 months (from before 1st treatment to surgery)
PERFORM (Multidimensional scale 12-60. The higher the less fatigue)
Time frame: 3-6 months (from 1st treatment to surgery)
percentage of intended doses that are administered in the due time
Time frame: three months
Surgical wound and pancreatic fistula
Time frame: 3-6 months (from 1st treatment to surgery)
body mass index
Time frame: 4-6 weeks after surgery
Percentage of patients with no viable cells in the surgical specimen
Time frame: Three months after surgery
Patients that received at least two cycles after surgery
Time frame: During the prehabilitation program (3-6 months for each patient)
Qualitative methods. semi-structured interviews and observation
Time frame: 3-6 months (from 1st treatment to surgery)
Hospital Anxiety and Depression Scale questionnaire. Values 8-21. The higher the worse
Time frame: before initiating chemotherapy
circulant tumor DNA
Puerta de Hierro University Hospital
Other
Trimodal Prehabilitation in Pancreatic Cancer Patients Candidate to Neoadjuvant Treatment: A Pilot Study
Acronym: PREPANC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)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.
Published trials that share one or more normalized conditions with this study.
NCT03535727
Adenocarcinoma, Carcinoma
Baltimore, Maryland, United States
View Trial DetailsNCT05546970
Digestive System Diseases, Digestive System Neoplasms
Strasbourg, France
View Trial DetailsNCT01964430
Adenocarcinoma, Antimetabolites, Antineoplastic
Scottsdale, Arizona, United States
View Trial DetailsNCT02810418
Digestive System Diseases, Digestive System Neoplasms
Bethesda, Maryland, United States
View Trial Details