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

NCT03974893 | Active Not Recruiting

• 1 other identifier: AAAR8814
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Sarcopenic Obesity

Keywords

Dietary intake; Diet; Acute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Association of a Vegetarian Diet and Sarcopenic Obesity

  6 months

Study Arms (2)

Vegetarian Diet

Includes children following a vegetarian diet.

Other: Vegetarian Diet

Non-Vegetarian Diet

Includes children following a non-vegetarian diet.

Interventions

Vegetarian Diet OTHER

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

Vegetarian Diet

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Columbia University: lead
• Tata Memorial Hospital: collaborator

Study Sites (1)

Tata Memorial Hospital

Mumbai, India

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Diet, Vegetarian

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Elena J. Ladas, PhD, RD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 5, 2019
• Study Start: April 18, 2019
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)