Improving Diet and Exercise in Acute Lymphoblastic Leukemia (IDEAL Weight in ALL)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Improving Diet and Exercise in Acute Lymphoblastic Leukemia (IDEAL Weight in ALL)

Conditions
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B Precursor Type Acute Leukemia

Intervention / Treatment
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* Behavioral: Dietary Intervention
* Behavioral: Activity and Exercise Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Greater than or equal to 10 years of age and less than or equal to 21 years of age at time of diagnosis Have a new diagnosis of untreated NCI/Rome High Risk B-precursor ALL (HR-ALL) Are beginning treatment on- or as per- a Children's Cancer Group/Children's Oncology Group (CCG-COG) protocol with a 4-drug Induction including vincristine, daunorubicin (or doxorubicin), asparaginase, and at least 14 days of glucocorticoid steroids Exclusion Criteria: Have a diagnosis of Down syndrome (Trisomy 21) or any genetic disease associated with abnormal body composition Be underweight or at risk for underweight with moderate weight loss, defined as a starting Body Mass Index (BMI) <10th percentile for age and sex (for those >20 years of age, defined as an absolute BMI < 18.5) Have pre-existing abnormal intestinal function (e.g. protein-wasting enteropathy, fat malabsorption) Be unable to comply with the recommended diet or activity interventions (as determined by study or treatment team) Have a history of prior chemotherapy or radiation for other cancers Be unable to complete the necessary radiology examinations with fully interpretable data (e.g. hip replacement and metal prostheses preclude evaluation by DXA) Be pregnant (to be confirmed by urine or serum pregnancy test as per institutional routine care for chemotherapy and radiology exams)

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Obesity Intervention<br>Personalized 28-day Dietary Intervention and Activity and Exercise Intervention with the goal to reduce fat gain and lean muscle loss while inducing an overall negative energy balance. | Behavioral: Dietary Intervention<br>* 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.<br>Behavioral: Activity and Exercise Intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Diagnosis and 28-35 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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). | 28 days |