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Clinical Trials in India / NCT03974893
Active, not recruiting Observational

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

NCT03974893 · tracked via the Priya Life Science India tracker
Sponsor
Columbia University
Phase
Observational
Started
2019-04-18
Last updated
2026-01-08

Condition(s) studied

Sarcopenic Obesity

Investigational drug(s) / intervention(s)

Vegetarian Diet

Vegetarian Diet: Dietary information will be collected utilizing a food record at four time points in therapy reflecting different intensities/drug exposures of treatment.

Study summary

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).

Eligibility

Sex
ALL
Min age
5 Years
Max age
15 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Tata Memorial Hospital Mumbai India

More Columbia University trials in India

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03974893 on ClinicalTrials.gov ↗ ← All trials in India