Nutrition and Body Composition in Acute Lymphoblastic Leukemia

NCT ID: NCT01317940

Last Updated: 2020-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2016-01-31

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.

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Vitamin D Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Group A (Newly Diagnosed Subjects)

Group Type: EXPERIMENTAL

Vitamin D and Calcium Citrate

Intervention Type: DIETARY_SUPPLEMENT

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

Standard of Care Group A

Group Type: NO_INTERVENTION

No interventions assigned to this group

Group B (Early Survivors)

Group Type: EXPERIMENTAL

Vitamin D and Calcium Citrate

Intervention Type: DIETARY_SUPPLEMENT

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

Observation Only - Group B

Group Type: NO_INTERVENTION

No interventions assigned to this group

Group C (Siblings of Group A)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Vitamin D and Calcium Citrate

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

1,25-Dihydroxycholecalciferol; Calcitriol; Rocaltrol (Roche); Calcium carbonate

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

• 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)

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 29 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Leukemia and Lymphoma Society

OTHER

Sponsor Role: collaborator

Children's Hospital Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Etan Orgel

Clinical Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Etan Orgel, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Los Angeles

Steven Mittelman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Los Angeles

Locations

Children's Hospital Los Angeles

Los Angeles, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33792627 (View on PubMed)

Related Links

http://ods.od.nih.gov/factsheets/vitamind/

NIH Vitamin D Fact Sheet

Other Identifiers

LLS 6249-11

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CCI-10-00273

Identifier Type: -

Identifier Source: org_study_id