This study tests the ability of a focused dietary, exercise, and activity intervention to reduce fat gain during induction therapy for childhood acute lymphoblastic leukemia to improve disease response and reduce toxicity.
In our previous study, we have observed that: 1) nearly half ALL patients are overweight or obese at diagnosis, 2) all patients, regardless of starting weight, gain significant fat mass over the first month of therapy (on average 20-30%), and 3) obesity at the time of diagnosis is associated with a higher likelihood of poor response to chemotherapy as evidenced by persistent leukemia (minimal residual disease) after induction therapy. Together, these data show that body fat is a significant risk factor for ALL treatment failure, and that its negative effects are evident within the first month of treatment. Recent laboratory and clinical data illustrates the ability of diet restriction and physical activity to improve chemotherapy efficacy, reduce treatment-related toxicities and better overall quality of life. Given the importance of successful induction therapy for ALL in predicting long term survival and the negative role of obesity on treatment success, this study tests a complete personalized dietary and exercise intervention for pre-adolescents, adolescents, and young adults newly diagnosed with B-precursor ALL ("pre-B ALL") that aims to reduce fat gained during induction therapy and thereby improve treatment response, toxicity rates, and quality of life.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Beginning at time of diagnosis, the dietary component of the intervention uses a personalized menu to implement high protein, moderate fat, and low glycemic index/high fiber diet to achieve a minimum net -10% daily caloric deficit during the induction phase of chemotherapy.
Beginning at the time of diagnosis, the exercise and activity component uses an "activity menu" to implement a target level of 200 minutes per week of moderate exercise activity (as estimated by metabolic equivalents) during the induction phase of chemotherapy.
Childrens Hospital Los Angeles
Los Angeles, California, United States
Fat Mass
Assessment of change in fat before and after the induction chemotherapy phase (first 28 days of chemotherapy) as measured dual-energy x-ray absorptiometry (DXA) in comparison to fat gain in a recent historical cohort. Calculated as (Day 28 Fat Mass - Diagnosis Fat Mass)/Diagnosis Fat Mass
Time frame: Diagnosis and 28-35 days
Percentage of Participants With Minimal Residual Disease >=0.01%
Compare the rate of minimal residual disease "positivity" (defined as \>=0.01%) in the bone marrow by flow cytometry after the induction phase of chemotherapy as compared to a recent historical cohort
Time frame: 28-35 days from diagnosis
Percentage of Successfully Completed Visits With Study Dietitian and Study Physiotherapist
Assess feasibility of incorporating the intervention into induction chemotherapy as defined by \>80% of overall scheduled study visits successfully completed. The expected number of overall visits is equal to the sum of total visits scheduled with the physiotherapist (PT) or the registered dietitian (RD). The measure was calculated as the total # expected visits/completed visits.
Time frame: 28 days
Percentage of Overall Adherence to the IDEAL Intervention
Overall adherence to the study intervention was calculated as the mean of dietary adherence (average of percent consumed calories/prescribed calories for each food group) and activity (self-reported % adherence to prescribed days).
Time frame: 28 days
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