Ignite Creation Date:
2025-12-25 @ 2:33 AM
Ignite Modification Date:
2025-12-30 @ 4:31 PM
Study NCT ID:
NCT06788834
Status:
RECRUITING
Last Update Posted:
2025-08-07
First Post:
2025-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multimodal Prehabilitation in Cancer Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-05', 'studyFirstSubmitDate': '2025-01-17', 'studyFirstSubmitQcDate': '2025-01-22', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the impact of prehabilitation on severe postoperative complications among high-risk patients undergoing oncological surgery', 'timeFrame': '30 days after surgery', 'description': 'The proportion of patients experiencing severe postoperative complications within 30 days after surgery defined as grade 3a or greater according to the Clavien-Dindo classification'}], 'secondaryOutcomes': [{'measure': 'Time to Functional Recovery (TFR)', 'timeFrame': '30 days after surgery', 'description': 'Faster return to basal functional preoperative capacity in treatment group'}, {'measure': 'Lenght of hospital stay (LOS)', 'timeFrame': '30 days after surgery', 'description': 'Reduction of lenght of hospital stay in treatment group'}, {'measure': 'Days at home up to 30 days after surgery (DAH-30)', 'timeFrame': '30 days after surgery', 'description': 'The mean number of days at home in the first 30 days after surgery will be compared between groups'}, {'measure': 'Complication severity', 'timeFrame': '30 days after surgery', 'description': 'Assess complication severity as measured by the Comprehensive Complication Index (CCI)'}, {'measure': 'Proportion of patients returning to preoperative functional walking capacity', 'timeFrame': '30 days after surgery', 'description': 'Improvement in the return to basal functional preoperative capacity'}, {'measure': 'Self-reported activity status and generic health related quality of life', 'timeFrame': '30 days after surgery', 'description': 'Assess quality of life in the first 30 days at home after surgery using the EuroQol-5 Dimension (EQ-5D-5L) questionnaire, a validated tool for evaluating health-related quality of life. The outcome will be reported as the mean EQ-5D-5L index score and the mean EQ-VAS score measured at 30 days postoperatively.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prehabilitation', 'Functional recovery', 'Relaxation', 'Exercise', 'Diet', 'Nutrition', 'Functional walking', 'Hospital stay', 'Multimodal prehabilitation program', 'Standard treatment', 'Anesthesiology'], 'conditions': ['Cancer Surgery']}, 'referencesModule': {'references': [{'pmid': '29262307', 'type': 'BACKGROUND', 'citation': 'Colado JC, Pedrosa FM, Juesas A, Gargallo P, Carrasco JJ, Flandez J, Chupel MU, Teixeira AM, Naclerio F. Concurrent validation of the OMNI-Resistance Exercise Scale of perceived exertion with elastic bands in the elderly. Exp Gerontol. 2018 Mar;103:11-16. doi: 10.1016/j.exger.2017.12.009. Epub 2017 Dec 17.'}, {'pmid': '29452805', 'type': 'BACKGROUND', 'citation': 'Levett DZH, Jack S, Swart M, Carlisle J, Wilson J, Snowden C, Riley M, Danjoux G, Ward SA, Older P, Grocott MPW; Perioperative Exercise Testing and Training Society (POETTS). Perioperative cardiopulmonary exercise testing (CPET): consensus clinical guidelines on indications, organization, conduct, and physiological interpretation. Br J Anaesth. 2018 Mar;120(3):484-500. doi: 10.1016/j.bja.2017.10.020. Epub 2017 Nov 24.'}, {'pmid': '35588252', 'type': 'BACKGROUND', 'citation': 'Molenaar CJ, van Rooijen SJ, Fokkenrood HJ, Roumen RM, Janssen L, Slooter GD. Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery. Cochrane Database Syst Rev. 2022 May 19;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub2.'}, {'pmid': '23756434', 'type': 'BACKGROUND', 'citation': 'Silver JK, Baima J. Cancer prehabilitation: an opportunity to decrease treatment-related morbidity, increase cancer treatment options, and improve physical and psychological health outcomes. Am J Phys Med Rehabil. 2013 Aug;92(8):715-27. doi: 10.1097/PHM.0b013e31829b4afe.'}, {'pmid': '23909073', 'type': 'BACKGROUND', 'citation': 'Lemanne D, Cassileth B, Gubili J. The role of physical activity in cancer prevention, treatment, recovery, and survivorship. Oncology (Williston Park). 2013 Jun;27(6):580-5.'}, {'pmid': '25501695', 'type': 'BACKGROUND', 'citation': 'Carli F. Physiologic considerations of Enhanced Recovery After Surgery (ERAS) programs: implications of the stress response. Can J Anaesth. 2015 Feb;62(2):110-9. doi: 10.1007/s12630-014-0264-0. Epub 2014 Dec 12.'}]}, 'descriptionModule': {'briefSummary': 'The PROPOSE RCT is a two-arm randomized controlled trial that will be conducted to test the efficacy of a personalized, multidisciplinary pre-operative prehabilitation program (preventive prehabilitation) to reduce serious complications and facilitate recovery after surgery in high-risk patients.\n\nThe multimodal prehabilitation program is a preoperative intervention that includes exercise training, nutritional therapy and anxiety reduction techniques, with the aim of preventing or mitigating the functional decline brought about by surgery. 400 patients scheduled for elective major abdominal (including urological), thoracic (including breast) or gynecological cancer surgery will be enrolled. They will be randomized (1:1 ratio) and assigned either to the intervention group (Prehabilitation) or to the control group, which will only be treated according to the usual standard of care within the Enhanced Recovery After Surgery (ERAS) pathways.', 'detailedDescription': "The standard treatment for most solid cancer includes surgery and concurrent medical therapies, both of which have been shown to significantly improve prognosis. However, cancer treatments impose impactful physiological stress and have detrimental effects on acute and long-term health outcomes.\n\nPhysical, nutritional, and mental status can influence surgical outcomes, functional recovery and quality of life throughout the course of the disease.\n\nThe importance of postoperative rehabilitation on physical performance and recovery is well-recognized. However, the preoperative period provides a unique opportunity to address comorbidities and modifiable risk factors. In addition, the metabolic stress induced by neoadjuvant therapy has been documented to frequently result in muscle atrophy and diminished functional capacity. The recognition that selected risk factors of poor postoperative outcome can be modified has prompted clinicians to identify proactive interventions to facilitate the recovery process. In this context, prehabilitation, aimed at enhancing the patients' functional capacity to enable them to withstand the physiological stress of surgery, has emerged as a promising approach. Although the term prehabilitation is not novel, the concept of optimizing patients before acute stressor or treatment has gained attention over the last decade. Nonetheless, quantifiable evidence of its effectiveness has yet to be fully demonstrated.\n\nThis study is a multicenter randomized controlled trial to assess the efficacy of personalized procedure-specific prehabilitation programs on patient-centered surgical outcomes. A total of 400 patients will be recruited by systematic screening of patients scheduled for elective surgical procedures. All patients undergoing elective major abdominal (including urological), thoracic (including breast) or gynecological cancer surgery undergoing major cancer surgery will be screened for eligibility and those who meet the inclusion/exclusion criteria will be approached for consent. Research personnel will use a web-based randomization system to assign patients (1:1 ratio) to either the prehabilitation or control arm. Study personnel will also collect data on recruitment rates, with reasons for non-enrolment.\n\nEligible patients will be randomly assigned to 1 of 2 treatments:\n\n1. multimodal prehabilitation program for at least three weeks started as soon as possible before surgery;\n2. standard care.\n\nThe multimodal prehabilitation program will be individualized by carefully integrating and adapting various components to meet individual needs. The program will last at least three weeks (plus maintenance in case of delayed surgery), and will incorporate exercise training, nutritional therapy, and anxiety reduction techniques. After enrollment, patients will receive initial contact from trained personnel through telemedicine. To ensure personalized care, a comprehensive assessment will be conducted to identify specific physical, nutritional, or psychological challenges. Based on this assessment, a customized intervention plan will be prescribed to achieve tailored exercise training, optimized nutrition, and effective distress-coping strategies. All patients will be reassessed the day before surgery and 30 days after surgery. Based on the data obtained during the multimodal assessment, different domains and levels of care will be prescribed, focusing on exercise training, nutrition optimization, or distress-coping techniques-or a combination of these"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient (age \\> 18 years);\n* Scheduled for elective major abdominal (including urological), thoracic (including breast) or gynecological cancer surgery;\n* Signed informed consent.\n\nExclusion Criteria:\n\nA) Co-morbid medical, physical, and mental conditions interfering with the ability to complete study procedures, such as:\n\n* Acute or unstable cardio-respiratory conditions (e.g., unstable angina or symptomatic severe aortic stenosis);\n* Severe/end-stage organ diseases (e.g., cardiac failure NYHA functional classes III-IV, COPD FEV1 \\<50% pred, end-stage kidney or liver disease);\n* American Society of Anesthesiologists (ASA) physical status classes 4-5;\n* Disabling orthopedic and neuromuscular disease;\n* Psychosis, dementia;\n* Symptomatic anemia with a hemoglobin value \\< 7 gr/dl.\n\nB) Patients with both optimal functional capacity (a Duke activity status index \\[DASI\\] score \\> 45) and optimal nutritional status (NRS-nutrition screening tool-score \\< 2).'}, 'identificationModule': {'nctId': 'NCT06788834', 'acronym': 'PROPOSE-RCT', 'briefTitle': 'Multimodal Prehabilitation in Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Università Vita-Salute San Raffaele'}, 'officialTitle': 'Multimodal Prehabilitation in Cancer Surgery PROPOSE Trial (PRehabilitation in Oncological Patients undergOing SurgEry): A Randomized Trial', 'orgStudyIdInfo': {'id': 'PNRR-MCNT2-2023-12378183'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prehabilitation', 'description': 'The prehabilitation arm group will receive preoperative intervention which includes exercise training, nutritional therapy and anxiety reducing techniques, aimed at preventing or attenuating surgery-driven functional decline. This will be on top of Standard care treatment with application of ERAS pathways (Enhanced Recovery After Surgery).', 'interventionNames': ['Behavioral: Multimodal prehabilitation Program']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Standard care treatment with application of ERAS pathways (Enhanced Recovery After Surgery)'}], 'interventions': [{'name': 'Multimodal prehabilitation Program', 'type': 'BEHAVIORAL', 'description': 'A tailored intervention will be prescribed if specific physical, nutritional or psychological impairments will be identified during the assessment phase.\n\nBased on the data obtained during the multimodal assessment, different domains and levels of care will be prescribed, focusing on exercise training, and/or nutrition optimization, and/or distress-coping techniques. Different combinations of three domains will be utilized to maximize their synergistic anabolic effects. The duration of the program will be set at a minimum of three weeks.', 'armGroupLabels': ['Prehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '88100', 'city': 'Catanzaro', 'state': 'Italy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Eugenio Garofalo, Professor', 'role': 'CONTACT', 'email': 'eugenio.garofalo@gmail.com', 'phone': '+393498125841'}], 'facility': 'Policlinico Universitario AOU Renato Dulbecco di Catanzaro', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}, {'zip': '50134', 'city': 'Florence', 'state': 'Italy', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gabriele Baldini, Professor', 'role': 'CONTACT', 'email': 'gabriele.baldini@unifi.it', 'phone': '+393333196036'}], 'facility': 'AOU Careggi', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '16128', 'city': 'Genova', 'state': 'Italy', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Claudia Brusasco, Doctor', 'role': 'CONTACT', 'email': 'claudia.brusasco@gmail.com', 'phone': '+393291185009'}], 'facility': 'Ospedale Galliera di Genova', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'zip': '20162', 'city': 'Milan', 'state': 'Italy', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Monica Gualtierotti, Doctor', 'role': 'CONTACT', 'email': 'monica.gualtierotti@ospedaleniguarda.it', 'phone': '+390264447918'}], 'facility': 'ASSTN GOM Niguarda', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20900', 'city': 'Monza', 'state': 'Italy', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luca C Nespoli, Professor', 'role': 'CONTACT', 'email': 'luca.nespoli@unimib.it', 'phone': '+393201797391'}], 'facility': 'IRCCS Ospedale San Gerardo dei Tintori', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'zip': '80129', 'city': 'Napoli', 'state': 'Italy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Pasquale Sansone, Professor', 'role': 'CONTACT', 'email': 'pasquale.sansone@unicampania.it', 'phone': '+393384969395'}], 'facility': 'Ospedale Vanvitelli di Napoli', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '35128', 'city': 'Padua', 'state': 'Italy', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Nicola Passuello, Doctor', 'role': 'CONTACT', 'email': 'nicola.passuello@aopd.veneto.it', 'phone': '+393482245159'}], 'facility': 'AOPD Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '33100', 'city': 'Udine', 'state': 'Italy', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Tiziana Bove, Professor', 'role': 'CONTACT', 'email': 'tiziana.bove@asufc.sanita.fvg.it', 'phone': '+393474785763'}], 'facility': 'Azienda sanitaria universitaria Friuli Centrale (ASU FC)', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}, {'zip': '20132', 'city': 'Milan', 'state': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Marina Pieri, MD', 'role': 'CONTACT', 'email': 'pieri.marina@hsr.it', 'phone': '0226438173', 'phoneExt': '+39'}, {'name': 'Marina Pieri, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS Ospedale San Raffaele', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Marina LG Pieri, Medical Doctor', 'role': 'CONTACT', 'email': 'pieri.marina@hsr.it', 'phone': '+393334625052'}], 'overallOfficials': [{'name': 'Marina Pieri, Medical Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Ospedale San Raffaele'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Università Vita-Salute San Raffaele', 'class': 'OTHER'}, 'collaborators': [{'name': 'Prof. Pasquale Sansone', 'class': 'UNKNOWN'}, {'name': 'Prof. Eugenio Garofalo', 'class': 'UNKNOWN'}, {'name': 'Prof. Tiziana Bove', 'class': 'UNKNOWN'}, {'name': 'Dr. Claudia Brusasco', 'class': 'UNKNOWN'}, {'name': 'Prof. Gabriele Baldini', 'class': 'UNKNOWN'}, {'name': 'Dr. Nicola Passuello', 'class': 'UNKNOWN'}, {'name': 'Dr. Monica Gualtierotti', 'class': 'UNKNOWN'}, {'name': 'Prof. Luca Carlo Nespoli', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Marina Pieri', 'investigatorAffiliation': 'Università Vita-Salute San Raffaele'}}}}