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

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ClinicalTrials.gov Identifier: NCT04469504
Recruitment Status : Recruiting
First Posted : July 14, 2020
Last Update Posted : February 8, 2023
Sponsor:
Collaborators:
Groupement Interrégional de Recherche Clinique et d'Innovation
Santelys Association
Information provided by (Responsible Party):
University Hospital, Lille

Study Description
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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.


Condition or disease Intervention/treatment Phase
Sarcopenia Pancreatic Cancer Other: Prehabilitation program Dietary Supplement: Oral Impact Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Prehabilitaion Program for Sarcopenic Patients Prior to Pancreaticoduodenectomy for Periampullary Malignant Tumors
Actual Study Start Date : May 17, 2022
Estimated Primary Completion Date : May 2028
Estimated Study Completion Date : May 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


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


Secondary Outcome Measures :
  1. Rate of Severe postoperative complications [ Time Frame: at 90 days ]
    Grade > IIIa (Clavien-Dindo classification)

  2. Overall survival [ Time Frame: at 1 year and at 3 years ]
  3. Program acceptance measure by Modified ACCEPT© questionnaire [ Time Frame: at 30 days ]
  4. Rate of program completion [ Time Frame: at 30 days ]
    self questionnaire to measure opinion with respect of rehabilitation program

  5. Satisfaction questionnaire by EVAN-G [ Time Frame: 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.

  6. Satisfaction questionnaire by the questionnaire for satisfaction of hospitalized (QSH-45) [ Time Frame: 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)

  7. Quality of life by EORTC-QLQc30 scale [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04469504


Contacts
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Contact: Mehdi ELAMRANI, MD 0320444465 ext +33 mehdi.elamrani@chru-lille.fr

Locations
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France
Hop Claude Huriez Chu Lille Recruiting
Lille, France
Sponsors and Collaborators
University Hospital, Lille
Groupement Interrégional de Recherche Clinique et d'Innovation
Santelys Association
Investigators
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Principal Investigator: Mehdi ELAMRANI, MD University Hospital, Lille
More Information
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT04469504    
Other Study ID Numbers: 2017_06
2019-A00632-55 ( Other Identifier: ID-RCB number,ANSM )
First Posted: July 14, 2020    Key Record Dates
Last Update Posted: February 8, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
morbimortality
Prehabilitaion
pancreatic surgery
cephalic duodenopancreatectomy
Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
 Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical