Low GI Diet in Children and Adolescents With ALL
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| ClinicalTrials.gov Identifier: NCT03157323 |
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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
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Sponsor:
Columbia University
Collaborators:
American Cancer Society, Inc.
Gabrielle's Angel Foundation
Information provided by (Responsible Party):
Elena Ladas, Columbia University
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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 |
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.
| 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 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Low Glycemic Index Diet
Following a low glycemic index diet verses a standard american diet.
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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 :
- 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.
Information from the National Library of Medicine
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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
| Contact: Michelle Walters, MS, RD | 6463172080 | mw3328@cumc.columbia.edu | |
| Contact: Elena Ladas, PhD | 2123057835 | ejd14@cumc.columbia.edu |
Locations
| 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
| Principal Investigator: | Elena Ladas, PhD | Columbia University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
| 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:
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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 |