Dietary Intake, Sarcopenic Obesity, and Other Treatment-Related Outcomes in Indian Children With Acute Lymphoblastic Leukemia (TATA)

Dietary Intake, Sarcopenic Obesity, and Other Treatment-Related Outcomes in Indian Children With Acute Lymphoblastic Leukemia: A Pilot Study

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Sarcopenic Obesity
• Intervention / Treatment: Other: Vegetarian Diet

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 115

Contacts and Locations

Study Locations

• India
  • Mumbai, India
    • Tata Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 15 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• Newly diagnosed with ALL
• Able to consume ≥ 80% of dietary requirements enterally
• Adequate performance status (Lansky score ≥70)
• Receiving standard treatment for ALL on or as per the Indian Childhood Collaborative Leukemia Group's protocol (ICiCLe).

Exclusion Criteria:

• Refusal of consent
• Relapsed ALL
• Down's syndrome; (Other congenital anomalies too)
• Therapy initiated elsewhere

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Vegetarian Diet; Includes children following a vegetarian diet.	Other: Vegetarian Diet; Dietary information will be collected utilizing a food record at four time points in therapy reflecting different intensities/drug exposures of treatment.
Non-Vegetarian Diet; Includes children following a non-vegetarian diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Sarcopenic Obesity	Incidence of sarcopenic obesity, measured by dual-energy x-ray absorptiometry (DEXA), among Indian children and adolescents with ALL.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association of a Vegetarian Diet and Sarcopenic Obesity	Association of a vegetarian compared to a non-vegetarian diet and sarcopenic obesity, measured by dual-energy x-ray absorptiometry (DEXA)	6 months

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: Tata Memorial Hospital
• Investigators: Principal Investigator: Elena J. Ladas, PhD, RD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2019
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: June 3, 2019
• First Submitted That Met QC Criteria: June 3, 2019
• First Posted (Actual): June 5, 2019

Study Record Updates

• Last Update Posted (Estimated): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Diet; Acute lymphoblastic leukemia; Dietary intake
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, Lymphoid; Leukemia; Hemic and Lymphatic Diseases; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Therapeutics; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Diet; Diet, Vegetarian
• Other Study ID Numbers: AAAR8814

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No