Clinical trial NCT01317940: Nutrition and Body Composition in Acute Lymphoblastic Leukemia
Official title: Nutrition and Body Composition in Acute Lymphoblastic Leukemia (Environment and Microenvironment in ALL #2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Precursor Cell Lymphoblastic Leukemia-Lymphoma
Vitamin D Deficiency
Keywords: Leukemia
ALL
Vitamin D
Bone Density
Body Fat
Obesity
Adipose
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
Collaborators: name: The Leukemia and Lymphoma Society
First posted: 2011-03-18
Enrollment: 76
Sex: ALL
Minimum age (years): 10
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria (All Groups):

* 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)

Primary outcomes:
measure: Change in Serum Vitamin D Level (Group A)
timeFrame: +6 months
Secondary outcomes:
measure: Bone Mineral Density by Quantitative Computed Tomography (QCT) at Study End (Group A)
timeFrame: +6 months
measure: Change in Vitamin D Level (Group B)
timeFrame: +6 months
measure: Bone Mineral Density by QCT in Survivors at Study End (Group B)
timeFrame: +6 months
measure: Prevalence of Obesity and Vitamin D Insufficiency in Adolescents With Newly Diagnosed ALL and in Their Siblings
timeFrame: 1 timepoint
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: Etan Orgel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Los Angeles
name: Steven Mittelman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.