SarcopeniaPSOASNCT04469504
Preoperative Prehabilitation for Sarcopenic Patients Prior to Pancreatic Surgery for Cancer
A study testing Prehabilitation program and Oral Impact in people with Sarcopenia and Pancreatic Cancer, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcopenia, Pancreatic Cancer
- What is being tested?
- Prehabilitation program and Oral Impact
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 17 May 2022to 17 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing pancreaticoduodenectomy for cancer
- Sarcopenic status
Who cannot join
- Age younger than 18 years
- Medical contraindications including cardiovascular disease or clinically significant vascular disease
- Physical inability to exercise
- Emergent surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prehabilitaion Program for Sarcopenic Patients Prior to Pancreaticoduodenectomy for Periampullary Malignant Tumors
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.
- Conditions
- Sarcopenia, Pancreatic Cancer
- Being tested
- Prehabilitation program, Oral Impact
- Keywords
- morbimortality, Prehabilitaion, pancreatic surgery, cephalic duodenopancreatectomy
- Medical subject headings
- Sarcopenia, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilitation programOther
4-week trimodal prehabilitation program: Exercise, nutritional supplementation, and psychological support
Oral ImpactDietary supplement
perioperative immunonutrition by ORAL IMPACT
| Study group | Role | What they receive |
|---|---|---|
| PREHAB | Experimental | Not described Receives: Other: Prehabilitation program |
| control group | Active comparator | Not described Receives: Dietary Supplement: Oral Impact |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative severe pancreatic fistula (Grade B and C)
Pancreatic fistula as defined by the International Study Group of pancreatic Fistula (ISGPF)
Measured: at 90 days
Secondary outcomes (7)
Rate of Severe postoperative complications
Grade > IIIa (Clavien-Dindo classification)
Measured: at 90 days
Overall survival
Measured: at 1 year and at 3 years
Program acceptance measure by Modified ACCEPT© questionnaire
Measured: at 30 days
Rate of program completion
self questionnaire to measure opinion with respect of rehabilitation program
Measured: 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.
Measured: 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)
Measured: 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.
Measured: at 1 month, 3 months, 6 months and at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start17 May 2022
- Primary completion2 Apr 2025
- Study completion17 Jun 2025
Why it stopped: The study was terminated prematurely due to patient inclusion difficulties.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Groupement Interrégional de Recherche Clinique et d'Innovation, Santelys Association
- Responsible party
- Sponsor
- Investigators
- Mehdi ELAMRANI, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04469504
- Sponsor's protocol ID
- 2017_06
- Other IDs
- 2019-A00632-55
- Acronym
- PSOAS
- Status last verified
- May 2026
- First submitted
- 9 Jul 2020
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehabilitaion Program for Sarcopenic Patients Prior to Pancreaticoduodenectomy for Periampullary Malignant Tumors
- ClinicalTrials.gov ID
- NCT04469504
- Acronym / sponsor ID
- PSOAS / 2017_06
- Conditions
- Sarcopenia, Pancreatic Cancer
- Keywords
- morbimortality, Prehabilitaion, pancreatic surgery, cephalic duodenopancreatectomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated prematurely due to patient inclusion difficulties.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Groupement Interrégional de Recherche Clinique et d'Innovation, Santelys Association
- Study start
- 17 May 2022 (actual)
- Primary completion
- 2 Apr 2025 (actual)
- Study completion
- 17 Jun 2025 (actual)
- First posted
- 14 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PREHAB | Experimental | Other: Prehabilitation program |
| control group | Active comparator | Dietary Supplement: Oral Impact |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing pancreaticoduodenectomy for cancer
- Sarcopenic status
Key exclusion criteria (4 listed)
- Age younger than 18 years
- Medical contraindications including cardiovascular disease or clinically significant vascular disease
- Physical inability to exercise
- Emergent surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prehabilitation program4-week trimodal prehabilitation program: Exercise, nutritional supplementation, and psychological support | Other | PREHAB |
| Oral Impactperioperative immunonutrition by ORAL IMPACT | Dietary supplement | control group |
Primary outcome
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)
7 secondary outcomes
Rate of Severe postoperative complications
Time frame: at 90 days
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
Satisfaction questionnaire by EVAN-G
Time frame: at 30 days
Satisfaction questionnaire by the questionnaire for satisfaction of hospitalized (QSH-45)
Time frame: at 30 days
Quality of life by EORTC-QLQc30 scale
Time frame: at 1 month, 3 months, 6 months and at 1 year
Results and safety
The study was stopped early (reason given: The study was terminated prematurely due to patient inclusion difficulties.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
Related trials for Sarcopenia
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
MF-300 for Treatment of Age-Related Sarcopenia
Sarcopenia in Elderly
Not yet recruitingObservational study
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
Hypothyroidism, Psychometrics
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehdi ELAMRANI, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation program and Oral Impact in people with Sarcopenia and Pancreatic Cancer, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was terminated prematurely due to patient inclusion difficulties.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative severe pancreatic fistula (Grade B and C) (time frame: at 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.