Low GI Diet for Leukemia

Not currently recruiting at 5 trial locations

Overseen By Elena Ladas, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Relapsed leukemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether children and teenagers undergoing treatment for acute lymphoblastic leukemia can feasibly maintain a low glycemic index diet, which focuses on foods that slowly release sugar into the bloodstream. Researchers aim to determine if participants can follow this diet during the first six months of leukemia treatment. Children and teens who are beginning their leukemia treatment and speak English or Spanish may be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance dietary recommendations for young leukemia patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that a low glycemic index diet is safe for children and adolescents with leukemia?

Research has shown that a low glycemic index diet, which includes foods that don't cause quick increases in blood sugar, is generally safe and easy to follow. Studies have found that this diet can help manage weight and blood sugar levels, especially in people with metabolic conditions. This suggests it might be a safe choice for children and teens being treated for acute lymphoblastic leukemia.

In other areas, such as epilepsy treatment, low glycemic index diets serve as a safer option compared to more restrictive diets like the ketogenic diet. This further supports the idea that they are generally well-tolerated. While this specific trial explores the diet's suitability for leukemia patients, existing evidence suggests it is a safe dietary approach for many people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the low glycemic index (GI) diet for leukemia because it offers a fresh approach compared to traditional treatments like chemotherapy and radiation. Unlike these standard treatments, which directly attack cancer cells, a low GI diet focuses on managing blood sugar levels and potentially influencing cancer growth indirectly. This dietary intervention is non-invasive, emphasizing lifestyle changes rather than medication, which might lead to fewer side effects and better quality of life for patients. By potentially slowing cancer progression through diet, this treatment could complement existing therapies and offer a novel way to support leukemia management.

What evidence suggests that a Low Glycemic Index Diet might be an effective treatment for leukemia?

Research has shown that low glycemic index (GI) diets can help manage body weight and maintain steady blood sugar levels, particularly for individuals with metabolic issues. These diets might also slow tumor growth in both mice and humans. A low GI diet includes foods that release sugar slowly into the bloodstream, which could be beneficial during cancer treatments. Studies indicate that low GI diets improve blood sugar control, helping to stabilize levels and potentially reduce the risk of other health problems. Although strong evidence for leukemia is lacking, the potential benefits of this diet make it worth considering as part of leukemia treatment. Participants in this trial will follow a low glycemic index diet to evaluate its effects compared to a standard American diet. ^{1 2 6 7 8}

Who Is on the Research Team?

Elena Ladas, PhD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for children and adolescents who have been diagnosed with Acute Lymphoblastic Leukemia (ALL), including B-Cell, T-Cell, or Mixed Phenotype. They must be within 3 days of starting the induction phase of their treatment and able to understand English or Spanish.

Inclusion Criteria

I have been diagnosed with Acute Lymphoblastic Leukemia.

I am starting treatment for Acute Lymphoblastic Leukemia within 3 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow a low glycemic index diet for 6 months while undergoing treatment for ALL

6 months

7 dietary recall assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Low Glycemic Index Diet

Trial Overview The study is testing a low glycemic index diet over a period of 6 months in young patients undergoing treatment for ALL. The goal is to see if this type of diet is practical and beneficial during leukemia treatment.

How Is the Trial Designed?

Group I: Low Glycemic Index Diet Experimental Treatment 1 Intervention

Following a low glycemic index diet verses a standard american diet.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Gabrielle's Angel Foundation

Collaborator

Trials

5

Recruited

320+

Published Research Related to This Trial

The IDEAL trial, involving 40 patients aged 10 to 21 with newly diagnosed B-cell acute lymphoblastic leukemia (B-ALL), showed that a diet and exercise intervention did not significantly reduce overall fat mass gain but effectively reduced fat gain in overweight/obese patients by 8.2% (from +9.7% to +1.5%).

The intervention also significantly decreased the risk of minimal residual disease (MRD) after chemotherapy, with an odds ratio of 0.30, suggesting that caloric restriction through diet and exercise may enhance chemotherapy efficacy in B-ALL patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caloric and nutrient restriction to augment chemotherapy efficacy for acute lymphoblastic leukemia: the IDEAL trial. Orgel, E., Framson, C., Buxton, R., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03157323

Study Details | NCT03157323 | Low GI Diet in Children and ... It is plausible that reducing the glycemic indices of diets during cancer treatment may have a profound clinical effect in this vulnerable pediatric population.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8778967/

Low-Glycemic Index Diets as an Intervention in Metabolic ... For patients with metabolic diseases, an LGID is more effective at controlling body mass and blood glucose than a high-GI or other diet.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33582533/

Efficacy of low glycemic index diet therapy (LGIT) in ... The overall compliance with the low glycemic diet in the intervention group was 88.5 %. Out of six responders to LGIT, one child achieved ...

4. clinicaladvisor.com clinicaladvisor.com/features/weighing-the-evidence-on-low-glycemic-index-diets/

Weighing the evidence on low glycemic index diets Findings from another meta-analysis by Willet et al indicated that low GI diets improved glycemic control and reduced the risk of developing ...

5. aacrjournals.org aacrjournals.org/cancerres/article/71/13/4484/567705/A-Low-Carbohydrate-High-Protein-Diet-Slows-Tumor

A Low Carbohydrate, High Protein Diet Slows Tumor Growth ... We found that both murine and human carcinomas grew slower in mice on diets containing low amylose CHO and high protein compared with a Western ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12538946/

Efficacy and tolerability of a low-glycemic-index ketogenic ... This study evaluates the efficacy of a low-glycemic-index diet (LGID) in improving neurodevelopmental and sleep outcomes in pediatric ...

7. epilepsy.com epilepsy.com/treatment/dietary-therapies/low-glycemic-index-treatment

Low Glycemic Index Treatment | Epilepsy Dietary Therapy The LGIT is a dietary therapy to improve seizure control. Low glycemic index treatment is an alternative to the keto diet. It focuses on low glycemic carbs.

8. mdpi.com mdpi.com/1648-9144/61/6/1025

The Influence of Metabolic Syndrome on the Development ... Patients with a high BMI (>40 kg/m2) show a 20%- or 1.18-times greater risk of developing colorectal cancer and a 1.72-times higher risk of developing ...