Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-27 @ 3:03 AM
Study NCT ID:
NCT06645093
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-08-12
First Post:
2024-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Intermittent Fasting During Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005215', 'term': 'Fasting'}, {'id': 'D000093763', 'term': 'Intermittent Fasting'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C407088', 'term': 'Angptl4 protein, mouse'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Safety and feasibility study,-pilot study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2024-10-14', 'studyFirstSubmitQcDate': '2024-10-15', 'lastUpdatePostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mechanistic aspects of fasting', 'timeFrame': '1 year', 'description': 'To better understand nutrition and metabolism related to fasting and cancer, we want to examine various biomarkers related to glucose, amino acid and fat metabolism, and inflammation, such as e.g. glucose, insulin, amino acids, triglycerides, C-reactive protein (CRP).'}, {'measure': 'Fasting and microbiota', 'timeFrame': '1 year', 'description': 'We will analyze the gut microbiota to explore the effect of fasting on the gut microbiota. We will collect feces samples at start and end of treatment to characterize the microbiota using high throughput sequencing.'}], 'primaryOutcomes': [{'measure': 'Safety, measured as 1) number of adverse events', 'timeFrame': '1 year', 'description': 'To test whether fasting is safe. 1) Explored by investigating adverse events from intermittent water-only fasting'}, {'measure': 'Safety, measured as 2) changes in body weight', 'timeFrame': '1 year', 'description': 'To test whether fasting is safe. 2) by investigating changes in body weight throughout the treatment comparing the intervention and control groups.'}, {'measure': 'Feasibility,- measured by 1) recruitment (attrition rate)', 'timeFrame': '1 year', 'description': 'Whether fasting is feasible. Explored in order to determine whether a larger trial can be successfully conducted in a similar setting with lymphoma patients fasting during cancer treatment.'}, {'measure': 'Feasibility,- measured as 2) compliance', 'timeFrame': '1 year', 'description': 'Whether fasting is feasible. Explored in order to determine whether a larger trial can be successfully conducted in a similar setting with lymphoma patients fasting during cancer treatment.'}, {'measure': 'Acceptability,- patient burden, acceptance and experience', 'timeFrame': '1 year', 'description': 'Whether fasting is acceptable. Explored from a perspective of the participant, as the degree to which patients find the trial, its procedures, and its interventions agreeable, suitable, and satisfactory during chemotherapy treatment'}], 'secondaryOutcomes': [{'measure': 'Adverse events from chemotherapy', 'timeFrame': '1 year', 'description': 'Adverse events including number of infections, graded according to Common Terminology Criteria for Adverse Events'}, {'measure': 'Toxicity, including hematological toxicity and standard organ toxicity', 'timeFrame': '1 year', 'description': 'Evaluation of toxicity, including hematological toxicity and other relevant organ toxicities with blood test and using computer tomography (CT) or fluoro-deoxy-glucose positron emission tomography computer tomography (FDG-PET-CT)'}, {'measure': 'Health-Related Quality of Life', 'timeFrame': '1 year', 'description': 'By using EORTC QLQ-C30 questionnaire'}, {'measure': 'Nutritional impact symptoms', 'timeFrame': '1 year', 'description': 'The linguistic and content validation of the translated and culturally adapted Patient Generated Subjective Global Assessment (PG-SGA) will be utilized for gathering data on nutritional impact symptoms'}, {'measure': 'Dietary intake', 'timeFrame': '1 year', 'description': 'Dietary intake 24 hours before and 24 hours after chemotherapy and the usual intake between chemotherapy cycles using food diary.'}, {'measure': 'Weight loss, body mass index (BMI) and body compositon', 'timeFrame': '1 year', 'description': 'Bioelectrical impedance (BIA) will be used to collect data to explore changes in body weight, BMI and body composition.'}, {'measure': 'Unplanned readmissions and hospitalization', 'timeFrame': '1 year', 'description': 'In terms of numbers of readmissions, unplanned out- or inpatient visits, and days in the hospital'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chemotherapeutic Toxicity', 'Chemotherapy', 'Adverse Effect', 'Short-term fasting', 'Feasibility studies', 'Fasting'], 'conditions': ['Lymphoma', 'Cancer', 'Fasting']}, 'descriptionModule': {'briefSummary': 'The goal of this randomized controlled parallel group trial is to examine if fasting before and after chemotherapy is safe, feasible and acceptable. The study population will include patients with either Hodgkin lymphoma or Diffuse Large B Cell Lymphoma.\n\nThe main questions aimed to answer are:\n\nWhether fasting during chemotherapy is safe for patients, whether it is feasible to implement in a clinical setting, and whether patients find it acceptable.\n\nWe also want to examine a number of patient-reported outcome measures regarding health status and quality of life, such as dietary intake and adverse events from chemotherapy.\n\nResearchers will compare fasting to standard treatment.\n\nParticipants will:\n\n* Fast 24 hours before and 24 hours after chemotherapy in addition to standard treatment or receive only standard treatment\n* Keep a diary of their dietary intake 24 hours before and 24 hours after chemotherapy\n* Keep a diary of their dietary intake for three consecutive days between chemotherapy cycles\n* Answer questionnaires/questions in relation to side effects from fasting, side effects/adverse events of chemotherapy, quality of life\n* Take bioimpedance analysis (including body mass index and body composition)\n* Take blood- and feces samples'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with diffuse large B-cell lymphoma planned to receive R-CHOP (rituximab, vincristine, doxorubicin, cyclophosphamide, and prednisolone) and Hodgkin lymphoma receiving ABVD (doxorubicin, bleomycin, vinblastine and dacarbazine)\n* Age ≥ 18 years\n* ECOG status 0-2\n* Normal weight and overweight (BMI ≥ 18,5 kg/m\\^2)\n\nExclusion Criteria:\n\n* Receiving concurrent radiation therapy and/or treatment\n* Other concomitant disease that may make intermittent fasting complicated such as diabetes mellitus\n* ECOG status: \\> 3\n* BMI \\< 18,5 kg/m2\n* Age \\> 80 years'}, 'identificationModule': {'nctId': 'NCT06645093', 'acronym': 'Fastestudien', 'briefTitle': 'Feasibility of Intermittent Fasting During Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Oslo'}, 'officialTitle': 'Intermittent Fasting During Curatively Intended Chemotherapy for Malignant Lymphoma - a Randomized Feasibility Trial', 'orgStudyIdInfo': {'id': 'FasteStudien'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fasting group', 'description': 'This group will fast 24 hours before and 24 hours after chemotherapy for all treatment cycles (4-6 cycles).', 'interventionNames': ['Other: Fasting']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'This group will receive standard treatment, which include no fasting.'}], 'interventions': [{'name': 'Fasting', 'type': 'OTHER', 'description': 'Fasting implies 0 kilojoule. Water ad libitum is permitted.', 'armGroupLabels': ['Fasting group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0372', 'city': 'Oslo', 'state': 'Oslo County', 'country': 'Norway', 'facility': 'Department of Nutrition, University of Oslo', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Sonja Brunvoll, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Nutrition, University of Oslo'}, {'name': 'Inger Ottestad, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Nutrition, University of Oslo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oslo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oslo University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postdoctoral researcher Sonja H. Brunvoll, PhD (co-PI together with Inger Ottestad, PhD)', 'investigatorFullName': 'Sonja H. Brunvoll, PhD', 'investigatorAffiliation': 'University of Oslo'}}}}