Preoperative Prehabilitation for Sarcopenic Patients Prior to Pancreatic Surgery for Cancer

NCT ID: NCT04469504

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-17

Study Completion Date

2028-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sarcopenia Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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PREHAB

Group Type EXPERIMENTAL

Prehabilitation program

Intervention Type OTHER

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

control group

Group Type ACTIVE_COMPARATOR

Oral Impact

Intervention Type DIETARY_SUPPLEMENT

perioperative immunonutrition by ORAL IMPACT

Interventions

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Prehabilitation program

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

Intervention Type OTHER

Oral Impact

perioperative immunonutrition by ORAL IMPACT

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Groupement Interrégional de Recherche Clinique et d'Innovation

OTHER

Sponsor Role collaborator

Santelys Association

OTHER

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mehdi ELAMRANI, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hop Claude Huriez Chu Lille

Lille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Mehdi ELAMRANI, MD

Role: CONTACT

0320444465 ext. +33

Other Identifiers

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2019-A00632-55

Identifier Type: OTHER

Identifier Source: secondary_id

2017_06

Identifier Type: -

Identifier Source: org_study_id

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