Nutrition and Body Composition in Acute Lymphoblastic Leukemia
2 other identifiers
interventional
76
1 country
1
Brief Summary
Many adolescents with acute lymphoblastic leukemia (ALL) have been found to have low bone density by the end of treatment. This can lead to long-term suffering in survivors due to poor bone health. Vitamin D is known to be associated with bone health and previous research has established that Vitamin D insufficiency is very common at diagnosis of ALL and worsens over the course of treatment. Researchers have also learned that a relationship exists between both Vitamin D and fat tissue and ALL and fat tissue. In adolescents being treated for ALL as well as in early survivors, this randomized study will therefore examine the effect of Vitamin D and calcium supplementation on correcting Vitamin D insufficiency and on improving bone density in the context of changes in body composition and body fat. Bone density will be measured by a radiology exam called qCT (quantitative computed tomography) while body composition and body fat will be measured by a different radiology exam called a DXA (dual energy x-ray absorptiometry scan) . The study will also examine in depth the relationship between these three elements - Vitamin D insufficiency, obesity, and ALL - and their impact on bone density.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2011
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 17, 2011
CompletedFirst Posted
Study publicly available on registry
March 18, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedResults Posted
Study results publicly available
July 8, 2020
CompletedJuly 8, 2020
June 1, 2020
3.8 years
March 17, 2011
August 21, 2017
June 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Serum Vitamin D Level (Group A)
Change in Vitamin D levels from baseline to study end (Group A: Consolidation through end of Delayed Intensification)
+6 months
Secondary Outcomes (4)
Bone Mineral Density by Quantitative Computed Tomography (QCT) at Study End (Group A)
+6 months
Change in Vitamin D Level (Group B)
+6 months
Bone Mineral Density by QCT in Survivors at Study End (Group B)
+6 months
Prevalence of Obesity and Vitamin D Insufficiency in Adolescents With Newly Diagnosed ALL and in Their Siblings
1 timepoint
Study Arms (5)
Group A (Newly Diagnosed Subjects)
EXPERIMENTALStandard of Care Group A
NO INTERVENTIONGroup B (Early Survivors)
EXPERIMENTALObservation Only - Group B
NO INTERVENTIONGroup C (Siblings of Group A)
NO INTERVENTIONInterventions
Vitamin D (10,000 int.units/ml) 100,000 int. units (10ml) by mouth once every two months x 3 times (total treatment period approximately 6-7 months) Calcium Carbonate (1,000 mg/tab = 400 mg elemental calcium/tab) 2,000 mg (2 chewable tabs) by mouth every day for approximately 6-7 months
Eligibility Criteria
You may qualify if:
- GROUP A: Patients with newly diagnosed ALL
- Are greater than or equal to 10 years of age and less than or equal to 21 years of age at diagnosis of ALL
- Have a new diagnosis of untreated ALL classified as "high risk" per NCI criteria (due to being greater than 10 years of age)
- Are beginning treatment with a Children's Cancer Group/Children's Oncology Group "high risk" protocol with a 4-drug induction including steroids
- Are not pregnant
- GROUP B: Early survivors of ALL
- Were treated for ALL and remain in first CR1 (complete remission)
- Were equal to or greater than 10 years of age and less than or equal to 21 years of age at diagnosis of ALL
- Have completed treatment on or as per a Children's Cancer Group/Children's Oncology Group "high risk" protocol between 12 and 48 months prior to enrollment in this study (consisting of a plan for a 4-drug induction including steroids in Induction, Delayed Intensification, and steroid pulses in Maintenance. Steroids are allowed to have been discontinued due to toxicity).
- Are not pregnant
- GROUP C: Siblings of Group A
- Are either a full-sibling or a half-sibling of a patient in Group A
- Are living at the same residence as the sibling/half-sibling from Group A
- Are greater than or equal to 10 years of age and less than or equal to 21 years of age at the time of study entry, and within 3 years of the age diagnosis of ALL in the sibling/half-sibling from Group A
- Are on the same Vitamin D supplementation regimen (if any) as the sibling from Group A at the time of his or her diagnosis
You may not qualify if:
- Have a diagnosis of Down syndrome (Trisomy 21) or any genetic disease associated with abnormal bone development
- Are undergoing treatment with other medicines that affect bones including chronic use of of steroids, bisphosphonate therapy, or Vitamin D at average dose greater than 400 international units (IU)/day
- Have an underlying diseases altering body structure (i.e. missing a limb, severe dysmorphism) or severely affecting mobility (i.e. total or hemiparesis)
- Have a history of chemotherapy or radiation for other cancers
- Cannot complete the radiology exams/radiology exams uninterpretable (i.e. people with a hip replacement or prosthesis)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Hospital Los Angeleslead
- The Leukemia and Lymphoma Societycollaborator
Study Sites (1)
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
Related Publications (1)
Orgel 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: 33792627DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Etan Orgel
- Organization
- Children's Hospital Los Angeles
Study Officials
- PRINCIPAL INVESTIGATOR
Etan Orgel, MD
Children's Hospital Los Angeles
- PRINCIPAL INVESTIGATOR
Steven Mittelman, MD, PhD
Children's Hospital Los Angeles
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Fellow
Study Record Dates
First Submitted
March 17, 2011
First Posted
March 18, 2011
Study Start
March 1, 2011
Primary Completion
December 1, 2014
Study Completion
January 1, 2016
Last Updated
July 8, 2020
Results First Posted
July 8, 2020
Record last verified: 2020-06