Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
Study NCT ID:
NCT04469504
Status:
RECRUITING
Last Update Posted:
2023-02-08
First Post:
2020-07-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Preoperative Prehabilitation for Sarcopenic Patients Prior to Pancreatic Surgery for Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 158}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2028-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-07', 'studyFirstSubmitDate': '2020-07-09', 'studyFirstSubmitQcDate': '2020-07-09', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative severe pancreatic fistula (Grade B and C)', 'timeFrame': 'at 90 days', 'description': 'Pancreatic fistula as defined by the International Study Group of pancreatic Fistula (ISGPF)'}], 'secondaryOutcomes': [{'measure': 'Rate of Severe postoperative complications', 'timeFrame': 'at 90 days', 'description': 'Grade \\> IIIa (Clavien-Dindo classification)'}, {'measure': 'Overall survival', 'timeFrame': 'at 1 year and at 3 years'}, {'measure': 'Program acceptance measure by Modified ACCEPT© questionnaire', 'timeFrame': 'at 30 days'}, {'measure': 'Rate of program completion', 'timeFrame': 'at 30 days', 'description': 'self questionnaire to measure opinion with respect of rehabilitation program'}, {'measure': 'Satisfaction questionnaire by EVAN-G', 'timeFrame': 'at 30 days', 'description': '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.'}, {'measure': 'Satisfaction questionnaire by the questionnaire for satisfaction of hospitalized (QSH-45)', 'timeFrame': 'at 30 days', 'description': "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)"}, {'measure': 'Quality of life by EORTC-QLQc30 scale', 'timeFrame': 'at 1 month, 3 months, 6 months and at 1 year', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['morbimortality', 'Prehabilitaion', 'pancreatic surgery', 'cephalic duodenopancreatectomy'], 'conditions': ['Sarcopenia', 'Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': "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.\n\nThe hypothesis is the preoperative management of sarcopenia by a rehabilitation program could improve patients' operative outcomes by reducing the rate of postoperative complications."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing pancreaticoduodenectomy for cancer\n* Sarcopenic status\n\nExclusion Criteria:\n\n* Age younger than 18 years\n* Medical contraindications including cardiovascular disease or clinically significant vascular disease\n* Physical inability to exercise\n* Emergent surgery'}, 'identificationModule': {'nctId': 'NCT04469504', 'acronym': 'PSOAS', 'briefTitle': 'Preoperative Prehabilitation for Sarcopenic Patients Prior to Pancreatic Surgery for Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Prehabilitaion Program for Sarcopenic Patients Prior to Pancreaticoduodenectomy for Periampullary Malignant Tumors', 'orgStudyIdInfo': {'id': '2017_06'}, 'secondaryIdInfos': [{'id': '2019-A00632-55', 'type': 'OTHER', 'domain': 'ID-RCB number,ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PREHAB', 'interventionNames': ['Other: Prehabilitation program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'interventionNames': ['Dietary Supplement: Oral Impact']}], 'interventions': [{'name': 'Prehabilitation program', 'type': 'OTHER', 'description': '4-week trimodal prehabilitation program: Exercise, nutritional supplementation, and psychological support', 'armGroupLabels': ['PREHAB']}, {'name': 'Oral Impact', 'type': 'DIETARY_SUPPLEMENT', 'description': 'perioperative immunonutrition by ORAL IMPACT', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hop Claude Huriez Chu Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'centralContacts': [{'name': 'Mehdi ELAMRANI, MD', 'role': 'CONTACT', 'email': 'mehdi.elamrani@chru-lille.fr', 'phone': '0320444465', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Mehdi ELAMRANI, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'collaborators': [{'name': "Groupement Interrégional de Recherche Clinique et d'Innovation", 'class': 'OTHER'}, {'name': 'Santelys Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}