Low GI Diet for Leukemia

Recruiting at 4 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

88 Participants Needed

What You Need to Know Before You Apply

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.

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.

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. ^{1 2 3 4 5}

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. ^{3 4 5 6 7}

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. ^{8 9 10 11 12}

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. United States pubmed.ncbi.nlm.nih.gov

Fasting selectively blocks development of acute lymphoblastic leukemia via leptin-receptor upregulation. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Growth and body composition in response to chemotherapy in children with acute lymphoblastic leukemia. [2007]

3. Netherlands pubmed.ncbi.nlm.nih.gov

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]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Cellular Oxidative Stress in Pediatric Leukemia and Lymphoma Patients Undergoing Treatment Is Associated with Protein Consumption. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Caloric and nutrient restriction to augment chemotherapy efficacy for acute lymphoblastic leukemia: the IDEAL trial. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Low glycemic index treatment in patients with drug-resistant epilepsy. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Efficacy, safety, and tolerability of the low glycemic index treatment in pediatric epilepsy. [2017]

8. England pubmed.ncbi.nlm.nih.gov

Low glycemic index diet in children and young adults with refractory epilepsy: first Italian experience. [2017]

9. United States pubmed.ncbi.nlm.nih.gov

Low glycemic index treatment for seizures in Angelman syndrome. [2012]

10. England pubmed.ncbi.nlm.nih.gov

A low glycemic index staple diet reduces postprandial glucose values in Asian women with gestational diabetes mellitus. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

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 States pubmed.ncbi.nlm.nih.gov

Glycemic index treatment using Japanese foods in a girl with Lennox-Gastaut syndrome. [2015]