Clinical trial · Interventional
Improving Diet and Exercise in Acute Lymphoblastic Leukemia (IDEAL Weight in ALL)
NCT02708108CI-TRIAL-00065087completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B Precursor Type Acute Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Activity and Exercise Intervention | Behavioral | — | UNRESOLVED |
| Dietary Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Obesity Intervention
- 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.
- interventionNames
- Behavioral: Dietary Intervention
- Behavioral: Activity and Exercise Intervention
Primary outcomes (1)
- measure
- Fat Mass
- timeFrame
- Diagnosis and 28-35 days
- description
- 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 outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
- Maximum age
- 21 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDOrgel E, Framson C, Buxton R, Kim J, Li G, Tucci J, Freyer DR, Sun W, Oberley MJ, Dieli-Conwright C, Mittelman SD. Caloric and nutrient restriction to augment chemotherapy efficacy for acute lymphoblastic leukemia: the IDEAL trial. Blood Adv. 2021 Apr 13;5(7):1853-1861. doi: 10.1182/bloodadvances.2020004018. PMID 33792627