88 Participants Needed

Low GI Diet for Leukemia

Recruiting at 4 trial locations
MW
EL
Overseen ByElena Ladas, PhD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Columbia University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

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 data supports the effectiveness of the Low Glycemic Index Diet treatment for leukemia?

Research suggests that dietary interventions, like fasting or caloric restriction, can help in treating leukemia by affecting certain biological pathways. For example, fasting has been shown to inhibit leukemia progression in mice by upregulating leptin-receptor signaling, and caloric restriction has been associated with improved chemotherapy outcomes in leukemia patients.12345

Is the Low GI Diet safe for humans?

Research on the Low Glycemic Index Treatment (LGIT) for epilepsy, including studies on children and young adults, shows it is generally safe with no reported adverse events.678910

How does the Low GI Diet treatment for leukemia differ from other treatments?

The Low GI Diet treatment is unique because it focuses on dietary changes by limiting foods with a high glycemic index (which measure how quickly foods raise blood sugar levels), rather than using medications. This approach is novel for leukemia as it is typically used for managing conditions like epilepsy and diabetes, where controlling blood sugar levels is crucial.89101112

What is the purpose of this trial?

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.

Research Team

EL

Elena Ladas, PhD

Principal Investigator

Columbia University

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Low Glycemic Index DietExperimental Treatment1 Intervention
Following a low glycemic index diet verses a standard american diet.

Find a Clinic Near You

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+

Findings from Research

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

References

Fasting selectively blocks development of acute lymphoblastic leukemia via leptin-receptor upregulation. [2021]
Growth and body composition in response to chemotherapy in children with acute lymphoblastic leukemia. [2007]
Clinical nutrition guidelines of the French Speaking Society of Clinical Nutrition and Metabolism (SFNEP): Summary of recommendations for adults undergoing non-surgical anticancer treatment. [2014]
Cellular Oxidative Stress in Pediatric Leukemia and Lymphoma Patients Undergoing Treatment Is Associated with Protein Consumption. [2020]
Caloric and nutrient restriction to augment chemotherapy efficacy for acute lymphoblastic leukemia: the IDEAL trial. [2022]
Low glycemic index treatment in patients with drug-resistant epilepsy. [2018]
Efficacy, safety, and tolerability of the low glycemic index treatment in pediatric epilepsy. [2017]
Low glycemic index diet in children and young adults with refractory epilepsy: first Italian experience. [2017]
Low glycemic index treatment for seizures in Angelman syndrome. [2012]
A low glycemic index staple diet reduces postprandial glucose values in Asian women with gestational diabetes mellitus. [2022]
Low glycemic index foods should play a role in improving overall glycemic control in type-1 and type-2 diabetic patients and, more specifically, in correcting excessive postprandial hyperglycemia. [2019]
12.United Statespubmed.ncbi.nlm.nih.gov
Glycemic index treatment using Japanese foods in a girl with Lennox-Gastaut syndrome. [2015]
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