Low GI Diet in Children and Adolescents With ALL
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Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
88 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Michelle Walters, MS, RD; Elena Ladas, PhD
Data sourced from clinicaltrials.gov
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