Improving Diet and Exercise in Acute Lymphoblastic Leukemia (IDEAL Weight in ALL)
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|ClinicalTrials.gov Identifier: NCT02708108|
Recruitment Status : Recruiting
First Posted : March 15, 2016
Last Update Posted : November 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|B Precursor Type Acute Leukemia||Behavioral: Dietary Intervention Behavioral: Activity and Exercise Intervention||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Improving Diet and Exercise in Acute Lymphoblastic Leukemia (IDEAL Weight in ALL)|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Obesity 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.
Behavioral: Dietary Intervention
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.
Behavioral: Activity and Exercise Intervention
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.
- Body Fat [ Time Frame: +28-35 days ]Assessment of change in body fat and lean muscle mass 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.
- Assessment of Minimal Residual Disease [ Time Frame: +28-35 days ]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
- Feasibility [ Time Frame: 28 days ]Assess feasibility of incorporating the intervention into induction chemotherapy as defined by >80% of scheduled visits overall and with the PT and RD (# completed visits/# scheduled visits)
- Adherence [ Time Frame: 28 days ]Assess adherence to the diet and activity components of the intervention defined by >75% adherence to the recommended diet changes (daily calories prescribed/intake, and % food group prescribed/ intake) and activity (prescribed minutes/actual minutes and prescribed metabolic equivalents/actual metabolic equivalents).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02708108
|Contact: Stephanie Garciaemail@example.com|
|Contact: Lakshmi Damerlafirstname.lastname@example.org|
|United States, California|
|Childrens Hospital Los Angeles||Recruiting|
|Los Angeles, California, United States, 90027|
|Contact: Stephanie Garcia 323-361-8897 email@example.com|
|Principal Investigator:||Etan Orgel, MD MS||Children's Hospital Los Angeles|
|Principal Investigator:||Steven D Mittelman, MD PhD||Children's Hospital Los Angeles|