Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-02-11 @ 7:41 PM
Study NCT ID:
NCT05420259
Status:
RECRUITING
Last Update Posted:
2024-03-19
First Post:
2022-06-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combined Exercise and Nutritional Intervention in GI Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D002100', 'term': 'Cachexia'}, {'id': 'D044342', 'term': 'Malnutrition'}], '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': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013851', 'term': 'Thinness'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-06-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-18', 'studyFirstSubmitDate': '2022-06-13', 'studyFirstSubmitQcDate': '2022-06-13', 'lastUpdatePostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change in interleukin 6 (IL6)', 'timeFrame': '8 weeks', 'description': 'IL6 circulating levels will be determined before and after combined exercise and dietary intervention (CEDI)'}], 'secondaryOutcomes': [{'measure': 'Change in Immune cell infiltration profile on tumor specimen', 'timeFrame': '8 weeks', 'description': 'Peri-tumoral cell distribution (NK cells, T cells) will be determined before and after combined exercise and dietary intervention (CEDI)'}, {'measure': 'Change in skeletal muscle', 'timeFrame': '8 weeks', 'description': 'Skeletal muscle using CT scan body composition analysis will be assessed before and after combined exercise and dietary intervention (CEDI)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Body composition', 'Wasting', 'Malnutrition'], 'conditions': ['Pancreatic Cancer', 'Gastric Cancer', 'Diet', 'Exercise']}, 'descriptionModule': {'briefSummary': "Although some studies have focused on the role of exercise on inflammation and cytokine expression in cancer patients undergoing treatment and survivors, to our knowledge none have investigated the effect of exercise during neoadjuvant treatment as a complementary therapy to 1) modulate inflammation which may have a positive influence on chemotherapy response and 2) preserve or improve skeletal muscle, thus preventing cancer cachexia. Furthermore, we believe that the neoadjuvant treatment period could be a window of opportunity to optimize patient's nutritional status before surgery, which until now has been under used.\n\nBearing in mind that nutritional interventions may also influence IL-6, our hypothesis is that a Combined Exercise and Dietary Intervention (CEDI) may induce positive alterations in cytokine profile and increase NK cell infiltration of the tumor in gastric and pancreatic cancer patients submitted to neo-adjuvant therapy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* gastric or pancreatic cancer stage II/III, eligible for neoadjuvant chemotherapy,\n* age higher than 40 years and lower than 80 years,\n* ECOG (Eastern Cooperative Oncology Group) functional status: 0-2,\n* sedentary/low physical activity level.\n\nExclusion Criteria:\n\n* life expectancy less than 12 months at inclusion,\n* chemotherapy regimen other than 5-Fluorouracil, Folinic acid, Oxaliplatin, Docetaxel (FLOT) for gastric and 5-Fluorouracil, Irinotecan and Oxaliplatin (FOLFIRINOX) or gemcitabine for pancreatic cancer,\n* metastatic disease,\n* chronic anti-inflammatory medication use,\n* known inflammatory condition (rheumatoid arthritis, ankylosing spondylitis or chronic active hepatitis)\n* cardiovascular, respiratory or musculoskeletal or joint problems that preclude moderate physical activity.'}, 'identificationModule': {'nctId': 'NCT05420259', 'briefTitle': 'Combined Exercise and Nutritional Intervention in GI Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Beatriz Ângelo'}, 'officialTitle': 'Influence of a Combined Dietary and Exercise Intervention on Cytokine Profile and NK Cell Activation in Cancer Patients Undergoing Neoadjuvant Treatment.', 'orgStudyIdInfo': {'id': '213/18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Combined Exercise and Dietary Intervention', 'description': "Intervention aimed at conveying a supervised combined moderate aerobic and resistance training, once a week with a duration of 40-60 minutes plus daily home exercise, personalized according to patients' age and functional status. Dietary intervention aimed at a one-on-one nutritional counseling. In the first visit a dietary plan is designed and one daily oral nutritional supplement (Fortimel Compact®, Nutricia) is given to meet the European Society of Parenteral and Enteral Nutrition (ESPEN) recommended intake.", 'interventionNames': ['Behavioral: Combined Exercise and Dietary Intervention (CEDI)']}, {'type': 'OTHER', 'label': 'Control', 'description': 'Standard Care', 'interventionNames': ['Behavioral: Standard Care']}], 'interventions': [{'name': 'Combined Exercise and Dietary Intervention (CEDI)', 'type': 'BEHAVIORAL', 'description': "The exercise program will be planned by an exercise physiologist and implemented by physiotherapists prior to rehabilitation physician assessment. In the first session patients will be evaluated by physiotherapist in order to allow personalization of exercise according to patient's age and functional capacity. In regard to diet, written materials will be given to patients and caregivers, namely a dietary plan, standard menus, recipes, and standard portions information.", 'armGroupLabels': ['Combined Exercise and Dietary Intervention']}, {'name': 'Standard Care', 'type': 'BEHAVIORAL', 'description': 'Standard Care', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2674-514', 'city': 'Loures', 'state': 'Lisbon District', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Velho', 'role': 'CONTACT', 'email': 'soniavelho0@gmail.com', 'phone': '+351914644141'}, {'name': 'Sónia Velho', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Beatriz Ângelo', 'geoPoint': {'lat': 38.83091, 'lon': -9.16845}}, {'city': 'Lisbon', 'status': 'NOT_YET_RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Sónia Velho', 'role': 'CONTACT'}], 'facility': 'Hospital da Luz', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}], 'centralContacts': [{'name': 'Sónia Velho', 'role': 'CONTACT', 'email': 'soniavelho0@gmail.com', 'phone': '+351914644141'}, {'name': 'Marilia Cravo', 'role': 'CONTACT', 'email': 'marilia.cravo@sapo.pt', 'phone': '919439192'}], 'overallOfficials': [{'name': 'Marilia Cravo', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital da Luz'}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Beatriz Ângelo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Nutricionist', 'investigatorFullName': 'Sónia Velho', 'investigatorAffiliation': 'Hospital Beatriz Ângelo'}}}}