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

Children's Hospital Los Angeles

Status: Completed

Conditions: B Precursor Type Acute Leukemia

Treatments: Behavioral: Dietary Intervention; Behavioral: Activity and Exercise Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02708108

CCI-14-00073

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 10 to 21 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

Obesity Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Dietary Intervention

Behavioral: Activity and Exercise Intervention