Clinical trial NCT03157323: Low GI Diet in Children and Adolescents With ALL
Official title: Implementing a Low Glycemic Diet in Children and Adolescents Undergoing Treatment for Acute Lymphoblastic Leukemia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Acute Lymphoblastic Leukemia, Pediatric
Obesity, Pediatric
Keywords: Glycemic Index
Acute Lymphoblastic Leukemia
Dietary Change
Pediatric Oncology
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
name: Gabrielle's Angel Foundation
First posted: 2017-05-17
Enrollment: 88
Sex: ALL
Minimum age (years): 5
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Feasibility of a 6-month low glycemic dietary intervention in children and adolescents undergoing treatment for ALL.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Washington
country: United States
facility: Children's National Hospital
state: District of Columbia
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Columbia University
name: Elena Ladas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Walters M, Mowbray C, Jubelirer T, Jacobs S, Kelly KM, Smith K, Yao Y, Jin Z, Ladas EJ. A bilingual dietary intervention early in treatment is feasible and prevents weight gain in childhood acute lymphoblastic leukemia. Pediatr Blood Cancer. 2021 May;68(5):e28910. doi: 10.1002/pbc.28910. Epub 2021 Feb 15.