N/A
N=123
Improving Diet and Exercise in Acute Lymphoblastic Leukemia (IDEAL Weight in ALL)
B Precursor Type Acute Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT02708108 ↗Enrolled (actual)
123
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcome: Primary: Fat Mass — 5.1; 10.7 percent change in fat mass
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dietary Intervention (Behavioral); Activity and Exercise Intervention (Behavioral)
- Age
- Pediatric, Adult · 10+ yrs
- Sex
- All
- Sponsor
- Children's Hospital Los Angeles
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fat Mass |
5.1; 10.7 | — |
| SECONDARY Percentage of Participants With Minimal Residual Disease >=0.01% |
12; 30 | 0.02 sig |
| SECONDARY Percentage of Successfully Completed Visits With Study Dietitian and Study Physiotherapist |
339 | — |
| SECONDARY Percentage of Overall Adherence to the IDEAL Intervention |
82.1 | — |
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.
Eligibility Criteria
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) 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)
Data sourced from ClinicalTrials.gov (NCT02708108). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.