Nutrition and Body Composition in Acute Lymphoblastic Leukemia
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Blood Cancer, Lymphoma, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Oncology, Other |
| Healthy: | No |
| Age Range: | 10 - 29 |
| Updated: | 10/14/2017 |
| Start Date: | March 2011 |
| End Date: | January 2016 |
Nutrition and Body Composition in Acute Lymphoblastic Leukemia (Environment and Microenvironment in ALL #2)
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 a
quantitative computed tomography (or "qCT") while body composition and body fat will be
measured by a different radiology exam called a dual energy x-ray absorptiometry (or "DEXA"
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.
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 a
quantitative computed tomography (or "qCT") while body composition and body fat will be
measured by a different radiology exam called a dual energy x-ray absorptiometry (or "DEXA"
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.
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 complete remission ("CR1")
- 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
400IU/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)
We found this trial at
1
site
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
Click here to add this to my saved trials
