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Spots Global Cancer Trial Database for Improving Diet and Exercise in Acute Lymphoblastic Leukemia (IDEAL Weight in ALL)

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Trial Identification

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

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

Study ID: NCT02708108

Study Description

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.

Keywords

Eligibility

Minimum Age: 10 Years

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Childrens Hospital Los Angeles, Los Angeles, California, United States

Contact Details

Name: Etan Orgel, MD MS

Affiliation: Children's Hospital Los Angeles

Role: PRINCIPAL_INVESTIGATOR

Name: Steven D Mittelman, MD PhD

Affiliation: Children's Hospital Los Angeles

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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