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This study is for older children, adolescents, and young adults with B-cell Acute Lymphoblastic Leukemia (B-ALL). Higher amounts of body fat is associated with resistance to chemotherapy in patients with B-ALL. Chemotherapy during the first month causes large gains in body fat in most people, even those who start chemotherapy at a healthy weight.
This study is being done to find out if caloric restriction achieved by a personalized nutritional menu and exercise plan during routine chemotherapy can make the patient's ALL more sensitive to chemotherapy and also reduce the amount of body fat gained during treatment. The goals of this study are to help make chemotherapy more effective in treating the patient's leukemia as demonstrated by fewer patients with leukemia minimal residual disease (MRD) while also trying to reduce the amount of body fat that chemotherapy causes the patient to gain in the first month.
Full description
GOALS AND OBJECTIVES
Hypothesis: Caloric restriction with increased physical activity integrated into induction chemotherapy will decrease chemoresistance and reduce minimal residual disease (MRD). In children receiving induction therapy for NCI/Rome high-risk B-cell acute lymphoblastic leukemia (HR B-ALL),
1.1 Primary Objectives
1.2 Secondary Objective
• To assess self-reported adherence (defined ≥75%) to the diet and activity components of the IDEAL intervention.
1.3 Exploratory Clinical Objectives
1.4 Exploratory Integrated Biology Objectives
OUTLINE: Patients are randomized to 1 of 2 arms
EXPERIMENTAL ARM: Standard of care nutrition education plus the updated "Improving Diet and Exercise in ALL" (IDEAL2) intervention to achieve calorie restriction through a personalized nutritional program and increased activity/exercise.
CONTROL ARM: One-time standard of care nutritional education session
All patients receive standard of care B-ALL chemotherapy.
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240 participants in 2 patient groups
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Central trial contact
Ellynore Florendo; Roy Leong
Data sourced from clinicaltrials.gov
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