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| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
| Gabrielle's Angel Foundation | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Glycemic Index Diet | Other | Following a low glycemic index diet verses a standard american diet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Glycemic Index Diet | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of a 6-month low glycemic dietary intervention in children and adolescents undergoing treatment for ALL. | 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. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elena Ladas, PhD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | United States | ||
| Children's National Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33590674 | Derived | 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. |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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|
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Columbia University | New York | New York | 10032 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |