Phase 2 Study of Caloric Restriction and Exercise to Improve Chemotherapy Response in B-cell Acute Lymphoblastic Leukemia in Young People

What this Trial Is About

This research focuses on older children, adolescents, and young adults diagnosed with B-cell Acute Lymphoblastic Leukemia B-ALL. It explores whether reducing calorie intake and increasing physical activity during standard chemotherapy can make the leukemia more responsive to treatment and limit the increase in body fat that usually occurs during the first month of chemotherapy. The study aims to reduce chemoresistance and minimal residual disease MRD while addressing treatment-related fat gain. Participants are randomly assigned to one of two groups. One group receives a personalized diet with at least a 15% daily calorie deficit, emphasizing low-fat and low-glycemic carbohydrate intake, combined with moderate exercise five days a week. The control group receives a single standard nutrition education session without the personalized intervention. All participants continue their regular chemotherapy treatment for B-ALL. During the study, participants are monitored from before day 5 until about day 35 of induction chemotherapy. Researchers assess MRD levels, changes in fat mass, adherence to diet and exercise plans, and various physical and metabolic outcomes. Additional evaluations include fitness tests, quality of life questionnaires, immune therapy use, and treatment side effects. The study also explores biological markers related to obesity and chemoresistance to better understand treatment responses.

Caloric Restriction and Activity to Reduce Chemoresistance in B-ALL