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

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ClinicalTrials.gov Identifier: NCT03974893
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : June 6, 2019
Sponsor:
Collaborator:
Tata Memorial Hospital
Information provided by (Responsible Party):
Elena Ladas, Columbia University

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).

Condition or disease Intervention/treatment
Sarcopenic Obesity 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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dietary Intake, Sarcopenic Obesity, and Other Treatment-Related Outcomes in Indian Children With Acute Lymphoblastic Leukemia: A Pilot Study
Actual Study Start Date : April 18, 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : December 2021


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.



Primary Outcome Measures :
  1. Incidence of Sarcopenic Obesity [ Time Frame: 6 months ]
    Incidence of sarcopenic obesity, measured by dual-energy x-ray absorptiometry (DEXA), among Indian children and adolescents with ALL.


Secondary Outcome Measures :
  1. Association of a Vegetarian Diet and Sarcopenic Obesity [ Time Frame: 6 months ]
    Association of a vegetarian compared to a non-vegetarian diet and sarcopenic obesity, measured by dual-energy x-ray absorptiometry (DEXA)



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Ages Eligible for Study:   5 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Fifty (50) 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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974893


Contacts
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Contact: Aryal Suvekshya 646-317-2070 sa3234@cumc.columbia.edu

Locations
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India
Tata Memorial Hospital Recruiting
Mumbai, India
Contact: Maya Prasad, MD       maya.prasad@gmail.com   
Contact: Riya Ghosh       riyaghosh028@gmail.com   
Principal Investigator: Maya Prasad, MD         
Sponsors and Collaborators
Columbia University
Tata Memorial Hospital
Investigators
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Principal Investigator: Elena J. Ladas, PhD, RD Columbia University

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Responsible Party: Elena Ladas, Associate Professor of Nutrition, Columbia University
ClinicalTrials.gov Identifier: NCT03974893     History of Changes
Other Study ID Numbers: AAAR8814
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Elena Ladas, Columbia University:
Dietary intake
Diet
Acute lymphoblastic leukemia

Additional relevant MeSH terms:
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Leukemia
Obesity
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases