Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-03-10 @ 11:45 PM
Study NCT ID:
NCT03974893
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-13
First Post:
2019-06-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dietary Intake, Sarcopenic Obesity, and Other Treatment-Related Outcomes in Indian Children With Acute Lymphoblastic Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014676', 'term': 'Diet, Vegetarian'}], 'ancestors': [{'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-11', 'studyFirstSubmitDate': '2019-06-03', 'studyFirstSubmitQcDate': '2019-06-03', 'lastUpdatePostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Sarcopenic Obesity', 'timeFrame': '6 months', 'description': 'Incidence of sarcopenic obesity, measured by dual-energy x-ray absorptiometry (DEXA), among Indian children and adolescents with ALL.'}], 'secondaryOutcomes': [{'measure': 'Association of a Vegetarian Diet and Sarcopenic Obesity', 'timeFrame': '6 months', 'description': 'Association of a vegetarian compared to a non-vegetarian diet and sarcopenic obesity, measured by dual-energy x-ray absorptiometry (DEXA)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dietary intake', 'Diet', 'Acute lymphoblastic leukemia'], 'conditions': ['Sarcopenic Obesity']}, 'descriptionModule': {'briefSummary': "Sarcopenic obesity occurs when there is a loss of muscle and gain of fat in the body. With this study, the investigators will explore how nutritional status at the beginning of the treatment can cause changes in your child's body fat compared to muscle in the body. The investigators will also look at how these changes can impact a child's cancer treatment, survival from treatment, and if there is any deterioration in health and nutrition status. The primary objective of this study is to establish the incidence of sarcopenic obesity, measured by dual-energy x-ray absorptiometry (DEXA), among Indian children and adolescents with acute lymphoblastic leukemia (ALL).", 'detailedDescription': 'Survival of childhood ALL exceeds 80% in an increasing number of many low-middle income countries (LMIC). Recent studies have found that the effects of obesity on survival are observed within the first several years of diagnosis, thus impacting immediate health outcome. Of concern is the developing body of evidence that the effects of obesity may be underestimated and its effect on outcome may be even more pronounced when it is defined by body composition. An elevated body mass index (BMI) can be comprised of increased fat-free mass (FFM) or fat-mass (FM) or a combination of both. Evidence suggests that an increase of FM is a stronger predictor of risk of chronic disease rather than BMI. The evaluation of FM and FFM appears to have clinical implications in both adult and pediatric oncology, particularly in patients with Sarcopenic Obesity (SO) (increased FM and reduced FFM). Among children with ALL located in both high income countries (HIC) and LMIC, remediation of poor nutritional status during treatment removes its adverse effect on survival at the end of treatment. targeting dietary patterns may be a more effective approach when considering dietary interventions. One plausible way to examine the association of dietary patterns with the development of SO in pediatric ALL is to compare a vegetarian diet to a non-vegetarian diet and investigate how they are associated with its development. Children and adolescents with ALL at Tata Memorial Center (TMC) are well suited for this investigation because at least 30% of children follow a vegetarian diet, are easily identified, and the diets are not interchangeable. The benefit of the proposed model eliminates the need for dietary intervention prior to the study, which will examine how SO, accumulation of FM and the loss of FFM, develops among children and adolescents with ALL adhering to a vegetarian compared to non-vegetarian diet. Additionally, this study will examine the interaction of physical activity and diet while considering influential variables on the development of SO.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '5 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '100 eligible children aged 5 - 15 years old will be recruited at Tata Memorial Hospital in Mumbai, India. Any children with deteriorating health or not being able to perform diet and exercise routines are ineligible. Children getting therapy outside Tata are not eligible.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Newly diagnosed with ALL\n* Able to consume ≥ 80% of dietary requirements enterally\n* Adequate performance status (Lansky score ≥70)\n* Receiving standard treatment for ALL on or as per the Indian Childhood Collaborative Leukemia Group's protocol (ICiCLe).\n\nExclusion Criteria:\n\n* Refusal of consent\n* Relapsed ALL\n* Down's syndrome; (Other congenital anomalies too)\n* Therapy initiated elsewhere"}, 'identificationModule': {'nctId': 'NCT03974893', 'acronym': 'TATA', 'briefTitle': 'Dietary Intake, Sarcopenic Obesity, and Other Treatment-Related Outcomes in Indian Children With Acute Lymphoblastic Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Dietary Intake, Sarcopenic Obesity, and Other Treatment-Related Outcomes in Indian Children With Acute Lymphoblastic Leukemia: A Pilot Study', 'orgStudyIdInfo': {'id': 'AAAR8814'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Vegetarian Diet', 'description': 'Includes children following a vegetarian diet.', 'interventionNames': ['Other: Vegetarian Diet']}, {'label': 'Non-Vegetarian Diet', 'description': 'Includes children following a non-vegetarian diet.'}], 'interventions': [{'name': 'Vegetarian Diet', 'type': 'OTHER', 'description': 'Dietary information will be collected utilizing a food record at four time points in therapy reflecting different intensities/drug exposures of treatment.', 'armGroupLabels': ['Vegetarian Diet']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mumbai', 'country': 'India', 'facility': 'Tata Memorial Hospital', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}], 'overallOfficials': [{'name': 'Elena J. Ladas, PhD, RD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tata Memorial Hospital', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}