Preoperative Prehabilitation for Sarcopenic Patients Prior to Pancreatic Surgery for Cancer

Study Overview
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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.

Official Title
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Prehabilitaion Program for Sarcopenic Patients Prior to Pancreaticoduodenectomy for Periampullary Malignant Tumors

Conditions
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Sarcopenia, Pancreatic Cancer

Intervention / Treatment
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* Other: Prehabilitation program
* Dietary Supplement: Oral Impact


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PREHAB<br> | Other: Prehabilitation program<br>* 4-week trimodal prehabilitation program: Exercise, nutritional supplementation, and psychological support<br>|
| Active Comparator: control group<br> | Dietary Supplement: Oral Impact<br>* perioperative immunonutrition by ORAL IMPACT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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morbimortality, Prehabilitaion, pancreatic surgery, cephalic duodenopancreatectomy