Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT04957693
Status:
UNKNOWN
Last Update Posted:
2023-04-21
First Post:
2021-07-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Vegan Diet and Lifestyle Changes on Indolent Lymphoma During Controlled Waiting Period
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000067269', 'term': 'Diet, Vegan'}], 'ancestors': [{'id': 'D014676', 'term': 'Diet, Vegetarian'}, {'id': 'D000095500', 'term': 'Diet, Plant-Based'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-20', 'studyFirstSubmitDate': '2021-07-05', 'studyFirstSubmitQcDate': '2021-07-05', 'lastUpdatePostDateStruct': {'date': '2023-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Response Rate', 'timeFrame': 'up to 36 months', 'description': 'Overall Response Rate (ORR) defined as the proportion of patients who achieve complete response (CR) and partial response (PR) determined by PET-CT imaging according to the 2014 Lugano criteria assessing FDG-PET/CT in lymphoma'}, {'measure': 'Partial remission or complete remission', 'timeFrame': 'up to 36 months', 'description': 'Response will be assessed by the revised Lugano classification'}], 'secondaryOutcomes': [{'measure': 'Disease Free Survival', 'timeFrame': 'up to 36 months', 'description': 'Disease-free survival defined as the time from the date of the first occurrence of a documented CR to the date of disease progression/ relapse, or death from any cause.'}, {'measure': 'Progression Free Survival', 'timeFrame': 'up to 36 months', 'description': 'The time from the start of treatment to the date of the first documented disease progression or death due to any cause. Based on blood tests, physical exams and Positron Emission Tomography Computed Tomography (PET -CT) Lugano classification'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Indolent Lymphoma']}, 'descriptionModule': {'briefSummary': 'The aim of the present trial is to evaluate the effect of lifestyle changes on the natural history of indolent lymphomas, during the period of watchful waiting. The intervention program is comprised of specifically designed vegan nutrition, physical activity, mostly aerobic, and stress reduction by relaxation and meditation. Outcome results will be followed and analyzed for 3 years, taking into consideration the following parameters - disease burden, specific disease-related symptoms, relevant blood tests, body weight, indicators of well-being. Changes in these parameters will be correlated with the level of compliance and adherence to the intervention program. The results of the trial group of patients will be further compared to the natural history of the disease in a comparable group of patients during their waiting period who were not subject to the above intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Patient sex - male and female\n* Diagnosis with indolent lymphoma in low-grade lymphoma (follicular lymphoma (FL), marginal zone lymphoma MZL), as assessed by Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria\n* Lack of need and non treatable patients at the time of diagnosis\n* Existence of detailed medical information about physical activity and dietary habits\n* Patients who have signed an informed consent form to participate in the study.\n\nExclusion Criteria:\n\n* Need for therapeutic intervention\n* Administration of chemotherapy and / or monoclonal antibodies or immunomodulatory preparation\n* Chronic inflammatory or infectious disease\n* Another malignant disease\n* Pregnant women, special populations - children and incapacitated of judgment"}, 'identificationModule': {'nctId': 'NCT04957693', 'briefTitle': 'Effect of Vegan Diet and Lifestyle Changes on Indolent Lymphoma During Controlled Waiting Period', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tel-Aviv Sourasky Medical Center'}, 'officialTitle': 'Effect of Vegan Diet and Lifestyle Changes on the Course and Progression of Indolent Lymphoma During Controlled Waiting Period', 'orgStudyIdInfo': {'id': '0264-18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'treatment arm', 'description': 'vegan diet and lifestyle change', 'interventionNames': ['Behavioral: vegan diet and lifestyle changes']}], 'interventions': [{'name': 'vegan diet and lifestyle changes', 'type': 'BEHAVIORAL', 'description': 'vegan diet and lifestyle changes', 'armGroupLabels': ['treatment arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Aviv', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': "Irit Avivi, Prof'", 'role': 'CONTACT', 'email': 'iritavi@tlvmc.gov.il', 'phone': '03-6943782'}, {'name': 'Ella Krayzler', 'role': 'CONTACT', 'email': 'ellakr@tlvmc.gov.il', 'phone': '03-6947395'}], 'facility': 'Tel-Aviv Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'centralContacts': [{'name': "Irit Avivi, Prof'", 'role': 'CONTACT', 'email': 'iritavi@tlvmc.gov.il', 'phone': '03-6943782'}, {'name': 'Ella Krayzler', 'role': 'CONTACT', 'email': 'ellakr@tlvmc.gov.il', 'phone': '03-6947395'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'KaMaH - The Center for Health-Promoting Therapies', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}