PREPANC: Trimodal Prehabilitation in Pancreatic Cancer Patients Urdergoing Neoadjuvant Treatment

Sponsor

Puerta de Hierro University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05722223

Collaborator

(none)

Enrollment

Location

Arm

21.2

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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 (SDT, Deci and Ryan) 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).

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Neoplasms	Combination Product: Trimodal prehabilitation	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

All the participants will receive trimodal prehabilitation. Only one armAll the participants will receive trimodal prehabilitation. Only one arm

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Trimodal Prehabilitation in Pancreatic Cancer Patients Candidate to Neoadjuvant Treatment: A Pilot Study

Actual Study Start Date :

Mar 15, 2022

Anticipated Primary Completion Date :

Mar 15, 2023

Anticipated Study Completion Date :

Dec 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Training group Pancreatic patients will participate in the trimodal prehabilitation: nutrition, psychological and exercise support.	Combination Product: Trimodal prehabilitation Pancreatic cancer patients (not stage 4) will undergo trimodal prehabilitation: nutrition, psychological, and exercise support.

Arm

Intervention/Treatment

Experimental: Training group

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

Combination Product: Trimodal prehabilitation

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

Outcome Measures

Primary Outcome Measures

To explore the feasibility of a trimodal prehabilitation program in the hospital setting [1 year]
Adherence to 70% of supervised physical exercise sessions and to nutrition and psychologist sessions

Secondary Outcome Measures

Changes in (estimated) cardiorespiratory fitness [3-6 months (from 1st treatment to surgery)]
Mile-time test
Changes in muscle strength [3-6 months (from 1st treatment to surgery)]
Handgrip by dynamometry
Changes in body mass index [3-6 months (from 1st treatment to surgery)]
BMI (Body Mass Index kg/sm)
Changes in body composition [3-6 months (from 1st treatment to surgery)]
waist, hip, calf circumferences
Changes in levels of physical activity at week [3-6 months (from 1st treatment to surgery)]
Accelerometry
Changes in quality of life [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.
Describe changes in fatigue levels [3-6 months (from before 1st treatment to surgery)]
PERFORM (Multidimensional scale 12-60. The higher the less fatigue)
Dose intensity in neoadjuvant treatment [3-6 months (from 1st treatment to surgery)]
percentage of intended doses that are administered in the due time
Describe post-surgical complications [three months]
Surgical wound and pancreatic fistula
Nutritional status [3-6 months (from 1st treatment to surgery)]
body mass index
Percentage of pathological complete responses [4-6 weeks after surgery]
Percentage of patients with no viable cells in the surgical specimen
Percentage of patients receiving adjuvant therapy [Three months after surgery]
Patients that received at least two cycles after surgery
Hindrances and facilitators of patients [During the prehabilitation program (3-6 months for each patient)]
Qualitative methods. semi-structured interviews and observation
Anxiety and depression [3-6 months (from 1st treatment to surgery)]
HADS questionnaire. Values 8-21. The higher the worse

Other Outcome Measures

Circulating tumor DNA and mutational variations [before initiating chemotherapy]
circulant tumor DNA

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario Puerta de Hierro Majadahonda	Majadahonda	Madrid	Spain	28222

Sponsors and Collaborators

Puerta de Hierro University Hospital

Investigators

Principal Investigator: Ana Ruiz-Casado, MD, HU Puerta de Hierro Majadahonda

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Ana Ruiz-Casado, Medical oncologist, Puerta de Hierro University Hospital

ClinicalTrials.gov Identifier:

NCT05722223

Other Study ID Numbers:

PH-UMH02

First Posted:

Feb 10, 2023

Last Update Posted:

Feb 10, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ana Ruiz-Casado, Medical oncologist, Puerta de Hierro University Hospital

Additional relevant MeSH terms:

Pancreatic Neoplasms

Study Results

No Results Posted as of Feb 10, 2023