Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:25 AM
Study NCT ID:
NCT07470268
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-18
First Post:
2026-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Hypertrophy-oriented Resistance Training on Muscle Mass and Quality of Life in Patients With Unresectable Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2026-03-03', 'studyFirstSubmitQcDate': '2026-03-09', 'lastUpdatePostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body Composition', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'The main objective of this study is to evaluate the effect on body composition (primarily lean mass) through 12 weeks of hypertrophy training in patients with advanced, non-operable pancreatic cancer undergoing treatment'}], 'secondaryOutcomes': [{'measure': 'VO2peak', 'timeFrame': 'Through study completion, an average of 1 year', 'description': '• To analyze whether 12 weeks of hypertrophy training in patients with advanced, unresectable pancreatic cancer receiving chemotherapy and/or immunotherapy has an impact on cardiorespiratory capacity.'}, {'measure': 'Patient-reported outcome measures', 'timeFrame': 'Through study completion, an average of 1 year', 'description': '• To identify whether 12 weeks of hypertrophy training in patients with advanced, unresectable pancreatic cancer receiving chemotherapy and/or immunotherapy impacts on quality of life. To assess quality of life, the European Organisation for Research and Treatment of Cancer quality of life Questionnaire C30 (EORTC QLQ-C30), version 3.0 will be used. The questionnaire consists of 30 questions grouped into several scales, with higher scores (0-100) indicating better functioning or higher symptom burden.'}, {'measure': 'Anxiety and Depression', 'timeFrame': 'Through study completion, an average of 1 year', 'description': '• To determine whether 12 weeks of hypertrophy training in patients with advanced, unresectable pancreatic cancer receiving chemotherapy and/or immunotherapy has an impact on anxiety and depression. It will be assesed through the validated questionnaire for assessing anxiety and depression in cancer patients, the Hospital Anxiety and Depression Scale (HADS). It is a 14-item, self-report screening tool used to identify and monitor emotional distress (anxiety and depression) in patients with physical health conditions. It consists of two subscales (7 questions each for anxiety and depression) and is commonly used in hospital settings.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['physical activity', 'physical function', 'body composition', 'lean mass', 'chemotherapy'], 'conditions': ['Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'To determine the efficacy of a 12-week supervised, hypertrophy-oriented strength training program in preserving skeletal muscle mass, physical function, and quality of life in patients with unresectable pancreatic cancer compared to standard care.', 'detailedDescription': 'Two-arm randomized controlled trial will recruit patients with unresectable pancreatic cancer undergoing chemotherapy. Participants will be randomized (1:1) to an Intervention Group (resistance training twice weekly) or a Control Group (standard care). The primary outcome is the change in total lean body mass (assessed by DXA) at week 12. Secondary outcomes include maximal strength, peak power, cardiorespiratory capacity, and patient-reported measures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of locally advanced or metastatic unresectable pancreatic cancer\n* Undergoing chemotherapy or immunotherapy treatment\n* Age ≥ 18 years\n* ECOG score ≤ 2\n\nExclusion Criteria:\n\n* Any relative or absolute contraindication that prevents the performance of training or physical tests.\n* Diagnosis of other types of primary cancer\n* Inability to understand Spanish for proper comprehension of the informed consent and questionnaires'}, 'identificationModule': {'nctId': 'NCT07470268', 'acronym': 'HY-PANC', 'briefTitle': 'Impact of Hypertrophy-oriented Resistance Training on Muscle Mass and Quality of Life in Patients With Unresectable Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Europea de Madrid'}, 'officialTitle': 'Impact of Hypertrophy-oriented Resistance Training on Muscle Mass and Quality of Life in Patients With Unresectable Pancreatic Cancer (HY-PANC): Study Protocol for a Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': '2026-544'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': '12 weeks of hypertrophy training in patients with advanced, unresectable PC receiving chemotherapy and/or immunotherapy', 'interventionNames': ['Other: supervised, hypertrophy-oriented strength training program']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Participants in the control group will receive standard oncological treatment. No restrictions on physical activity will be imposed. Furthermore, they will be offered the opportunity to follow the exercise program used in the intervention group if the expected benefits proposed in the study hypothesis are confirmed.'}], 'interventions': [{'name': 'supervised, hypertrophy-oriented strength training program', 'type': 'OTHER', 'description': '12-week supervised, hypertrophy-oriented strength training program in preserving skeletal muscle mass', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28670', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'contacts': [{'name': 'Pablo B Arias, Msc', 'role': 'CONTACT', 'email': 'pablo.braceras@universidadeuropea.es', 'phone': '+34 636620771'}], 'facility': 'Universidad Europea de Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.', 'ipdSharing': 'YES', 'description': 'Data will be available, including de-identified individual participant data, data dictionaries, and study protocols.', 'accessCriteria': 'Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact investigacion@universidadeuropea.es'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Europea de Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Lidia Brea Alejo', 'investigatorAffiliation': 'Universidad Europea de Madrid'}}}}