Trimodal Prehabilitation in Pancreatic Cancer Patients Urdergoing Neoadjuvant Treatment

Pancreatic Neoplasms Clinical Trial

— PREPANC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05722223
• Other study ID #: PH-UMH02
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2022
• Est. completion date: August 20, 2024

Study information

• Verified date: April 2024
• Source: Puerta de Hierro University Hospital
• Contact: Ana Ruiz-Casado, MD
• Phone: 607890187
• Email: arcasado[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: August 20, 2024
• Est. primary completion date: April 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitario Puerta de Hierro Majadahonda	Majadahonda	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Puerta de Hierro University Hospital

Country where clinical trial is conducted

Spain, 

References & Publications (28)

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Circulating tumor DNA and mutational variations	circulant tumor DNA	before initiating chemotherapy
Primary	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	Changes in (estimated) cardiorespiratory fitness	Mile-time test	3-6 months (from 1st treatment to surgery)
Secondary	Changes in muscle strength	Handgrip by dynamometry	3-6 months (from 1st treatment to surgery)
Secondary	Changes in body mass index	BMI (Body Mass Index kg/sm)	3-6 months (from 1st treatment to surgery)
Secondary	Changes in body composition	waist, hip, calf circumferences	3-6 months (from 1st treatment to surgery)
Secondary	Changes in levels of physical activity at week	Accelerometry	3-6 months (from 1st treatment to surgery)
Secondary	Changes in quality of life	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.	3-6 months (from before1st treatment to surgery)
Secondary	Describe changes in fatigue levels	PERFORM (Multidimensional scale 12-60. The higher the less fatigue)	3-6 months (from before 1st treatment to surgery)
Secondary	Dose intensity in neoadjuvant treatment	percentage of intended doses that are administered in the due time	3-6 months (from 1st treatment to surgery)
Secondary	Describe post-surgical complications	Surgical wound and pancreatic fistula	three months
Secondary	Nutritional status	body mass index	3-6 months (from 1st treatment to surgery)
Secondary	Percentage of pathological complete responses	Percentage of patients with no viable cells in the surgical specimen	4-6 weeks after surgery
Secondary	Percentage of patients receiving adjuvant therapy	Patients that received at least two cycles after surgery	Three months after surgery
Secondary	Hindrances and facilitators of patients	Qualitative methods. semi-structured interviews and observation	During the prehabilitation program (3-6 months for each patient)
Secondary	Anxiety and depression	Hospital Anxiety and Depression Scale questionnaire. Values 8-21. The higher the worse	3-6 months (from 1st treatment to surgery)