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Low GI Diet in Children and Adolescents With ALL

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ClinicalTrials.gov Identifier: NCT03157323
Recruitment Status : Unknown
Verified June 2019 by Elena Ladas, Columbia University.
Recruitment status was:  Recruiting
First Posted : May 17, 2017
Last Update Posted : June 12, 2019
Sponsor:
Collaborators:
American Cancer Society, Inc.
Gabrielle's Angel Foundation
Information provided by (Responsible Party):
Elena Ladas, Columbia University

Brief Summary:
The study aims to determine the feasibility of a 6-month low glycemic dietary intervention in children and adolescents undergoing treatment for acute lymphoblastic leukemia.

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia, Pediatric Obesity, Pediatric Behavioral: Low Glycemic Index Diet Not Applicable

Detailed Description:
Acute lymphoblastic leukemia (ALL) is the most common childhood malignancy with survival exceeding 90%. However, treatment-related toxicity remains a clinical challenge during and after treatment. Evidence-based, nutritional interventions may minimize the development of nutrition-related toxicities, such as bone morbidities, hypertriglyceridemia, and obesity. To date, no effective interventions are available to prevent nutrition-related morbidities in children with ALL. Clinical studies evaluating the glycemic indices in other pediatric conditions have been encouraging. It is plausible that reducing the glycemic indices of diets during cancer treatment may have a profound clinical effect in this vulnerable pediatric population. Prior to the design and implementation of randomized, controlled trials, epidemiological data describing the Glycemic Index (GI) and Glycemic Load (GL) and the association with clinically important outcomes is needed. Additionally, the feasibility of a dietary intervention must also be explored within the setting of pediatric cancer. This study aims to determine the feasibility, measured by compliance to a low-GI diet, of a 6-month low glycemic dietary intervention in children and adolescents undergoing treatment for ALL. The proposed work will be used for the design and implementation of a multi-center nutritional intervention aimed at improving dietary intake during treatment and its effect on clinically important outcomes. Importantly, the information will be used to drive the formation of evidence-based nutritional guidelines for children with cancer, which will expand into the emerging field of individualized medicine for patients with cancer.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Implementing a Low Glycemic Diet in Children and Adolescents Undergoing Treatment for Acute Lymphoblastic Leukemia
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020


Arm Intervention/treatment
Low Glycemic Index Diet
Following a low glycemic index diet verses a standard american diet.
Behavioral: Low Glycemic Index Diet
The nutritional intervention is theory-based and will provide nutritional education and counseling to children and their families. Nutritional counseling will be provided by the institutional designate and will focus on increasing patients' understanding of the benefits of a low GI diet, increase knowledge of low GI diet, overcoming barriers, and establishing expectations of the diet.




Primary Outcome Measures :
  1. Feasibility of a 6-month low glycemic dietary intervention in children and adolescents undergoing treatment for ALL. [ Time Frame: 6 months ]
    Feasibility will be measured by compliance to a low glycemic index diet, which will be measured via 24 dietary recall, using the Automated Self-Administered 24-Hour Dietary Assessment Tool. A dietary recall will be taken at 7 timepoints from diagnosis to end of treatment; each recall will be defined categorically as high compliance (GI score <55), moderate compliance (GI score 56-69) and low compliance (GI score >70). Change in glycemic index score will show compliance.



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Ages Eligible for Study:   5 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Acute Lymphoblastic Leukemia (B-Cell, T-Cell, or Mixed Phenotype)
  • Within 3 days of starting the induction phase of treatment for Acute Lymphoblastic Leukemia
  • Proficient in English or Spanish

Exclusion Criteria:

  • Diagnosis of relapsed Acute Lymphoblastic Leukemia
  • Not meeting all of the inclusion criteria

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): NCT03157323


Contacts
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Contact: Michelle Walters, MS, RD 6463172080 mw3328@cumc.columbia.edu
Contact: Elena Ladas, PhD 2123057835 ejd14@cumc.columbia.edu

Locations
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United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Andrea Orsey, MD         
United States, District of Columbia
Children's National Hospital Recruiting
Washington, District of Columbia, United States, 20010
Contact: Jacobs Shana, MD         
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Kara Kelly, MD         
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Michelle Walters, MS, RD         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Tracey Jubelirer, MD         
Sponsors and Collaborators
Columbia University
American Cancer Society, Inc.
Gabrielle's Angel Foundation
Investigators
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Principal Investigator: Elena Ladas, PhD Columbia University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Elena Ladas, Assistant Professor of Nutrition in Pediatrics and in the Institute of Human Nutrition, Columbia University
ClinicalTrials.gov Identifier: NCT03157323    
Other Study ID Numbers: AAAQ9790
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: June 12, 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:
Glycemic Index
Acute Lymphoblastic Leukemia
Dietary Change
Pediatric Oncology
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Pediatric Obesity
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight