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

Not Applicable

Completed

Interventions: Behavioral: Dietary Intervention
Behavioral: Activity and Exercise Intervention

Brief Summary: 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: 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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Obesity Intervention	Activity and Exercise Intervention	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.
Obesity Intervention	Dietary Intervention	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.

Primary Outcome Measures

Name	Time	Method
Fat Mass	Diagnosis and 28-35 days	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

Secondary Outcome Measures

Name	Time	Method
Percentage of Overall Adherence to the IDEAL Intervention	28 days	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).
Percentage of Successfully Completed Visits With Study Dietitian and Study Physiotherapist	28 days	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.
Percentage of Participants With Minimal Residual Disease >=0.01%	28-35 days from diagnosis	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