Preoperative Prehabilitation for Sarcopenic Patients Prior to Pancreatic Surgery for Cancer

Not Applicable

Recruiting

• Conditions: Sarcopenia; Pancreatic Cancer
• Interventions: Other: Prehabilitation program; Dietary Supplement: Oral Impact

• Registration Number: NCT04469504
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-09
• Study First Submitted QC: 2020-07-09
• Study First Posted: 2020-07-14
• Study Start: 2022-05-17
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-08
• Primary Completion: 2028-05
• Study Completion: 2028-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 158

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PREHAB	Prehabilitation program	-
control group	Oral Impact	-

Primary Outcome Measures

Name	Time	Method
Post-operative severe pancreatic fistula (Grade B and C)	at 90 days	Pancreatic fistula as defined by the International Study Group of pancreatic Fistula (ISGPF)

Secondary Outcome Measures

Name	Time	Method
Rate of Severe postoperative complications	at 90 days	Grade \> IIIa (Clavien-Dindo classification)
Overall survival	at 1 year and at 3 years
Program acceptance measure by Modified ACCEPT© questionnaire	at 30 days
Rate of program completion	at 30 days	self questionnaire to measure opinion with respect of rehabilitation program
Satisfaction questionnaire by EVAN-G	at 30 days	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)	at 30 days	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	at 1 month, 3 months, 6 months and at 1 year	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.

Trial Locations

Locations (1)

Hop Claude Huriez Chu Lille; 🇫🇷 Lille, France