Preoperative Prehabilitation For Sarcopenic Patients Prior To Pancreatic Surgery For Cancer

Study Overview

Preoperative Prehabilitation for Sarcopenic Patients Prior to Pancreatic Surgery for Cancer

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.

N/A

Sarcopenia
Pancreatic Cancer

OTHER: Prehabilitation program
DIETARY_SUPPLEMENT: Oral Impact

2017_06
2019-A00632-55 (OTHER Identifier) (OTHER: ID-RCB number,ANSM)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-07-09	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-02-07
First Submitted that Met QC Criteria 2020-07-09	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-02-08
First Posted (ACTUAL) 2020-07-14	Results First Posted N/A	Last Verified 2023-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Other

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Double

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: PREHAB	OTHER: Prehabilitation program 4-week trimodal prehabilitation program: Exercise, nutritional supplementation, and psychological support
ACTIVE_COMPARATOR: control group	DIETARY_SUPPLEMENT: Oral Impact perioperative immunonutrition by ORAL IMPACT

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: PREHAB

OTHER: Prehabilitation program

4-week trimodal prehabilitation program: Exercise, nutritional supplementation, and psychological support

ACTIVE_COMPARATOR: control group

DIETARY_SUPPLEMENT: Oral Impact

perioperative immunonutrition by ORAL IMPACT

Primary Outcome Measures	Measure Description	Time Frame
Post-operative severe pancreatic fistula (Grade B and C)	Pancreatic fistula as defined by the International Study Group of pancreatic Fistula (ISGPF)	at 90 days

Secondary Outcome Measures	Measure Description	Time Frame
Rate of Severe postoperative complications	Grade > IIIa (Clavien-Dindo classification)	at 90 days
Overall survival		at 1 year and at 3 years
Program acceptance measure by Modified ACCEPT© questionnaire		at 30 days
Rate of program completion	self questionnaire to measure opinion with respect of rehabilitation program	at 30 days
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.	at 30 days
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)	at 30 days
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.	at 1 month, 3 months, 6 months and at 1 year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Mehdi ELAMRANI, MD

Phone Number: 0320444465

Email: mehdi.elamrani@chru-lille.fr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Patients undergoing pancreaticoduodenectomy for cancer
Sarcopenic status

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Groupement Interrégional de Recherche Clinique et d'Innovation
Santelys Association

Investigators

PRINCIPAL_INVESTIGATOR: Mehdi ELAMRANI, MD, University Hospital, Lille

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record