search
Back to results

Preoperative Prehabilitation for Sarcopenic Patients Prior to Pancreatic Surgery for Cancer (PSOAS)

Primary Purpose

Sarcopenia, Pancreatic Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Prehabilitation program
Oral Impact
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sarcopenia focused on measuring morbimortality, Prehabilitaion, pancreatic surgery, cephalic duodenopancreatectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing pancreaticoduodenectomy for cancer
  • Sarcopenic status

Exclusion Criteria:

  • Age younger than 18 years
  • Medical contraindications including cardiovascular disease or clinically significant vascular disease
  • Physical inability to exercise
  • Emergent surgery

Sites / Locations

  • Hop Claude Huriez Chu LilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PREHAB

control group

Arm Description

Outcomes

Primary Outcome Measures

Post-operative severe pancreatic fistula (Grade B and C)
Pancreatic fistula as defined by the International Study Group of pancreatic Fistula (ISGPF)

Secondary Outcome Measures

Rate of Severe postoperative complications
Grade > IIIa (Clavien-Dindo classification)
Overall survival
Program acceptance measure by Modified ACCEPT© questionnaire
Rate of program completion
self questionnaire to measure opinion with respect of rehabilitation program
Satisfaction questionnaire by EVAN-G
EVAN-G general patient satisfaction questionnaire consisting of 26 items divided into 6 sub-sections scoring on a scale from 0 to 100. It is designed to report perioperative problems.
Satisfaction questionnaire by the questionnaire for satisfaction of hospitalized (QSH-45)
French self-administered instrument for measuring hospitalized patients' satisfaction based on the patient's point of view. QSH contained 45 items describing 9 dimensions, leading to 2 composite scores (staff and structure index)
Quality of life by EORTC-QLQc30 scale
The QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients. The questionnaire includes one global health status/QoL scale, five functional scales and three symptom scale. Each scale is scored from 0 to 100. A high score on a scale indicate a good outcome for the dimension of QoL.

Full Information

First Posted
July 9, 2020
Last Updated
February 7, 2023
Sponsor
University Hospital, Lille
Collaborators
Groupement Interrégional de Recherche Clinique et d'Innovation, Santelys Association
search

1. Study Identification

Unique Protocol Identification Number
NCT04469504
Brief Title
Preoperative Prehabilitation for Sarcopenic Patients Prior to Pancreatic Surgery for Cancer
Acronym
PSOAS
Official Title
Prehabilitaion Program for Sarcopenic Patients Prior to Pancreaticoduodenectomy for Periampullary Malignant Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2022 (Actual)
Primary Completion Date
May 2028 (Anticipated)
Study Completion Date
May 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Groupement Interrégional de Recherche Clinique et d'Innovation, Santelys Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Major digestive surgery is associated with a significant rate of postoperative complications. To improve postoperative outcome, efforts are focused on postoperative course leading to the concept of rehabilitation. However, the rehabilitation concept does not allow to improve muscular and functional reserves at the time of surgery. Sarcopenia is a condition characterized by loss of skeletal muscle mass and function. Also, the prevalence of sarcopenia in patients with cancer is high and has a prevalence of around 25% in patients with pancreatic cancer, with a considerable impact on postoperative and survival outcomes. The hypothesis is the preoperative management of sarcopenia by a rehabilitation program could improve patients' operative outcomes by reducing the rate of postoperative complications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Pancreatic Cancer
Keywords
morbimortality, Prehabilitaion, pancreatic surgery, cephalic duodenopancreatectomy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
158 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PREHAB
Arm Type
Experimental
Arm Title
control group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Prehabilitation program
Intervention Description
4-week trimodal prehabilitation program: Exercise, nutritional supplementation, and psychological support
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral Impact
Intervention Description
perioperative immunonutrition by ORAL IMPACT
Primary Outcome Measure Information:
Title
Post-operative severe pancreatic fistula (Grade B and C)
Description
Pancreatic fistula as defined by the International Study Group of pancreatic Fistula (ISGPF)
Time Frame
at 90 days
Secondary Outcome Measure Information:
Title
Rate of Severe postoperative complications
Description
Grade > IIIa (Clavien-Dindo classification)
Time Frame
at 90 days
Title
Overall survival
Time Frame
at 1 year and at 3 years
Title
Program acceptance measure by Modified ACCEPT© questionnaire
Time Frame
at 30 days
Title
Rate of program completion
Description
self questionnaire to measure opinion with respect of rehabilitation program
Time Frame
at 30 days
Title
Satisfaction questionnaire by EVAN-G
Description
EVAN-G general patient satisfaction questionnaire consisting of 26 items divided into 6 sub-sections scoring on a scale from 0 to 100. It is designed to report perioperative problems.
Time Frame
at 30 days
Title
Satisfaction questionnaire by the questionnaire for satisfaction of hospitalized (QSH-45)
Description
French self-administered instrument for measuring hospitalized patients' satisfaction based on the patient's point of view. QSH contained 45 items describing 9 dimensions, leading to 2 composite scores (staff and structure index)
Time Frame
at 30 days
Title
Quality of life by EORTC-QLQc30 scale
Description
The QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients. The questionnaire includes one global health status/QoL scale, five functional scales and three symptom scale. Each scale is scored from 0 to 100. A high score on a scale indicate a good outcome for the dimension of QoL.
Time Frame
at 1 month, 3 months, 6 months and at 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing pancreaticoduodenectomy for cancer Sarcopenic status Exclusion Criteria: Age younger than 18 years Medical contraindications including cardiovascular disease or clinically significant vascular disease Physical inability to exercise Emergent surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mehdi ELAMRANI, MD
Phone
0320444465
Ext
+33
Email
mehdi.elamrani@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehdi ELAMRANI, MD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hop Claude Huriez Chu Lille
City
Lille
Country
France
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Preoperative Prehabilitation for Sarcopenic Patients Prior to Pancreatic Surgery for Cancer

We'll reach out to this number within 24 hrs