Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 11:25 PM
Study NCT ID:
NCT05023993
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-07
First Post:
2021-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Exercise and Nicotinamide Riboside Muscle Health and Insulin Resistance in Survivors of Childhood Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D011236', 'term': 'Prediabetic State'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C018613', 'term': 'nicotinamide-beta-riboside'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-09-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-06', 'studyFirstSubmitDate': '2021-08-04', 'studyFirstSubmitQcDate': '2021-08-20', 'lastUpdatePostDateStruct': {'date': '2025-11-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of a nutrition and exercise program in childhood cancer survivors (CCS)', 'timeFrame': 'Up to 6 weeks', 'description': 'The current protocol will be considered feasible if:\n\n1. \\>= 50% of eligible patients that are approached for participation enroll onto the study,\n2. \\>= 70% of enrolled participants successfully complete all study assessments (i.e. physical function tests, blood draw, imaging, and questionnaires at baseline and 6 weeks, and\n3. Enrolled participants demonstrate \\>= 70% compliance with prescribed exercise and nicotinamide riboside.\n\nFeasibility measures 2 and 3 will be assessed for the entire group of 20 subjects as a whole.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hematopoietic and Lymphoid Cell Neoplasm', 'Malignant Solid Neoplasm', 'Prediabetes']}, 'descriptionModule': {'briefSummary': 'This trial studies the effect of exercise and nicotinamide riboside on muscle health and insulin resistance in adult survivors of childhood cancer with prediabetes (elevated blood sugar level that is not high enough to be considered diabetes). Nicotinamide riboside is a dietary supplement which is similar to vitamin B3. Information collected in this study may help the future development of regimens to improve metabolic outcomes such as muscle health and insulin resistance (when the body is not normally responding to insulin) in childhood cancer survivors.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. Evaluate the feasibility of conducting a home exercise and nutrition intervention in childhood cancer survivors (CCS) with a history of prediabetes.\n\nEXPLORATORY OBJECTIVES:\n\nI. Describe the association between patient demographics and treatment exposures and subsequent hyperglycemia and skeletal muscle health in childhood cancer survivors.\n\nII. Describe the effect of exercise with or without nicotinamide riboside (NR) on hyperglycemia and skeletal muscle health in CCS with a history of prediabetes.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM I: Patients complete 18 home exercise sessions over 30 minutes each, 3 days per weeks for 6 weeks.\n\nARM II: Patients complete home exercise as in Arm I. Patients also receive nicotinamide riboside orally (PO) daily for 6 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of childhood cancer\n* History of prediabetes (HbA1c 5.7-6.4%)\n* In remission at time of enrollment\n* Time between completion of cancer-directed therapy and study entry: \\>= 6 months\n* At least 18 years of age at time of enrollment\n* Able to access online exercise program at home\n* Ability to tolerate the prescribed resistance exercise program\n* English-speaking\n* Able to understand and sign the study specific informed consent form (ICF)\n\nExclusion Criteria:\n\n* Taking a nicotinamide adenine dinucleotide (NAD)+ precursor in the two weeks prior to enrollment\n* Currently taking medication for hyperglycemia or diabetes\n* Females who are pregnant or planning to become pregnant\n* Currently recovering from an injury\n* Contraindication to magnetic resonance imaging (MRI)\n* Pacemaker'}, 'identificationModule': {'nctId': 'NCT05023993', 'briefTitle': 'The Effect of Exercise and Nicotinamide Riboside Muscle Health and Insulin Resistance in Survivors of Childhood Cancer', 'organization': {'class': 'OTHER', 'fullName': 'City of Hope Medical Center'}, 'officialTitle': 'The Effect of Exercise and Nicotinamide Riboside on Muscle Health and Insulin Resistance in Adult Survivors of Childhood Cancer With Prediabetes: A Pilot Feasibility Study', 'orgStudyIdInfo': {'id': '20676'}, 'secondaryIdInfos': [{'id': 'NCI-2021-02807', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '20676', 'type': 'OTHER', 'domain': 'City of Hope Medical Center'}, {'id': 'P30CA033572', 'link': 'https://reporter.nih.gov/quickSearch/P30CA033572', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm I (home exercise)', 'description': 'Patients complete 18 home exercise sessions over 30 minutes each, 3 days per weeks for 6 weeks.', 'interventionNames': ['Other: Exercise Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II (home exercise, nicotinamide riboside)', 'description': 'Patients complete home exercise as in Arm I. Patients also receive nicotinamide riboside PO daily for 6 weeks.', 'interventionNames': ['Other: Exercise Intervention', 'Dietary Supplement: Nicotinamide Riboside']}], 'interventions': [{'name': 'Exercise Intervention', 'type': 'OTHER', 'description': 'Complete home exercise', 'armGroupLabels': ['Arm I (home exercise)', 'Arm II (home exercise, nicotinamide riboside)']}, {'name': 'Nicotinamide Riboside', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Niagen', 'NR'], 'description': 'Given PO', 'armGroupLabels': ['Arm II (home exercise, nicotinamide riboside)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}], 'overallOfficials': [{'name': 'Rusha Bhandari', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'City of Hope Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'City of Hope Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}