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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 9, 2020
First Posted Date  ICMJE July 14, 2020
Last Update Posted Date February 8, 2023
Actual Study Start Date  ICMJE May 17, 2022
Estimated Primary Completion Date May 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2020)		 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2020)
  • Rate of Severe postoperative complications [ Time Frame: at 90 days ]
    Grade > IIIa (Clavien-Dindo classification)
  • Overall survival [ Time Frame: at 1 year and at 3 years ]
  • Program acceptance measure by Modified ACCEPT© questionnaire [ Time Frame: at 30 days ]
  • Rate of program completion [ Time Frame: at 30 days ]
    self questionnaire to measure opinion with respect of rehabilitation program
  • 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.
  • 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)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preoperative Prehabilitation for Sarcopenic Patients Prior to Pancreatic Surgery for Cancer
Official Title  ICMJE Prehabilitaion Program for Sarcopenic Patients Prior to Pancreaticoduodenectomy for Periampullary Malignant Tumors
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE
  • Sarcopenia
  • Pancreatic Cancer
Intervention  ICMJE
  • Other: Prehabilitation program
    4-week trimodal prehabilitation program: Exercise, nutritional supplementation, and psychological support
  • Dietary Supplement: Oral Impact
    perioperative immunonutrition by ORAL IMPACT
Study Arms  ICMJE
  • Experimental: PREHAB
    Intervention: Other: Prehabilitation program
  • Active Comparator: control group
    Intervention: Dietary Supplement: Oral Impact
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 9, 2020)		 158
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2028
Estimated Primary Completion Date May 2028   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mehdi ELAMRANI, MD 0320444465 ext +33 mehdi.elamrani@chru-lille.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04469504
Other Study ID Numbers  ICMJE 2017_06
2019-A00632-55 ( Other Identifier: ID-RCB number,ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University Hospital, Lille
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospital, Lille
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Groupement Interrégional de Recherche Clinique et d'Innovation
  • Santelys Association
Investigators  ICMJE
Principal Investigator: Mehdi ELAMRANI, MD University Hospital, Lille
PRS Account University Hospital, Lille
Verification Date February 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP