Breast, Breast Cancer, Osteoporosis
Conditions
Keywords
Bone Density
Brief summary
This is a randomized study evaluating the effects of early intensive vitamin D supplementation compared to standard of care vitamin D supplementation on bone health over an 18 month period.
Detailed description
This is a randomized, open-label study designed to evaluate the effect of high dose vitamin D versus standard of care vitamin D supplementation on bone health and arthralgias. The randomization will be stratified by hormone receptor status (positive versus negative). The primary objective is to compare the effect of high dose vitamin D to the current standard vitamin D treatment administration algorithm on bone health, as measured by percent change from baseline in bone mineral density (g/cm2), in young women with non-metastatic breast cancer who receive systemic therapy.
Interventions
DIETARY_SUPPLEMENTHigh Dose Vitamin D
High dose vitamin D: Subjects will receive 50,000 IU vitamin D2 weekly x 16 weeks followed by 4,000 IU of vitamin D3 daily with a goal 25(OH)D level of ≥45 but ≤80 ng/mL.
DIETARY_SUPPLEMENTStandard of Care Vitamin D
Standard of Care Vitamin D: Vitamin D will be supplemented to 25(OH)D levels, with a goal 25(OH)D level of \>30 ng/mL according to Endocrine Society Practice Guidelines.
Sponsors
Atrium Health Levine Cancer Institute
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
Subject must meet all of the following applicable inclusion criteria to participate in this study: 1. Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. 2. Age; 45 years at the time of consent 3. Female 4. Histological or cytological confirmation of breast cancer clinical or pathologic stages 0-III 5. Patient has been recommended to initiate systemic therapy for breast cancer. It is preferable for patient to enroll prior to systemic therapy initiation. However, enrollment will be allowed if systemic therapy has been initiated within 4 weeks prior to enrollment (randomization). Note: Patients who undergo only surgery and/or radiotherapy alone would not qualify for the study. 6. Systemic therapy for breast cancer is planned 7. As determined by the enrolling physician, ability of the subject to understand and comply with study procedures for the entire length of the study 8. Previous vitamin D supplementation allowed, as long as patient is agreeable to stop previous dosing at the time of trial enrollment, to comply with trial procedures including a baseline 25(OH)D level, and is otherwise determined to be appropriate for enrollment
Exclusion criteria
Subjects meeting any of the criteria below may not participate in the study: 1. Uncontrolled intercurrent illness/medical condition or psychiatric illness/social situations that would limit compliance with study requirements as determined by the Investigator 2. Patients will undergo breast surgery and/or radiotherapy alone without planned neoadjuvant and/or adjuvant anti-cancer drug therapy. 3. Baseline 25(OH)D level \<10ng/mL or \>80ng/mL 4. Baseline serum corrected calcium level of \>10.3mg/dL 5. Bone mineral density less than the expected range for age on baseline DEXA scan (defined as Z-score \</= -2.0) 6. Breast cancer with distant metastasis 7. History of previous breast cancer 8. Postmenopausal, as confirmed by the lack of menses \>/=12 months and/or ovarian function laboratories (estradiol, FSH) consistent with menopause (if any of two values outside of menopausal range and subject had menses within 12 months, subject would be considered perimenopausal or premenopausal and therefore eligible for enrollment) 9. Pregnancy or lactation 10. History of bone disease, including Paget's bone disease or osteomalacia 11. Concurrent rheumatoid or other inflammatory arthritis 12. Concurrent or prior treatment with bisphosphonates 13. Use of oral corticosteroids within the last 30 days prior to randomization 14. Concurrent treatment for thyroid deficiency 15. BMI \<18.5 16. Currently receiving treatment for tuberculosis, or planning to receive treatment for tuberculosis during breast cancer treatments 17. History of another primary cancer that required systemic treatment within the last 5 years 18. Any of the following kidney diseases at the time of randomization: active chronic kidney disease \>/= stage 3, history of kidney stones, sarcoidosis 19. Gastrointestinal disease that would limit the absorption of pill therapy (i.e. celiac disease, gastric bypass surgery)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change from baseline in bone mineral density (g/cm^2) from baseline to the Year 1 DEXA scan | 15 months (12 plus a +3 month calendar window) | Compare effect of high dose vitamin D to the current standard vitamin D treatment administration algorithm on bone health, as measured by percent change from baseline in bone mineral density (g/cm2) to the Year 1 planned DEXA scan, in young women with non-metastatic breast cancer who receive systemic therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 25(OH) D level over time | 18 months | Compare effect of high dose vitamin D to the current standard vitamin D treatment administration algorithm 25(OH) D levels in young women with non-metastatic breast cancer who receive systemic therapy. |
| PRAI questionnaire results over time | 18 months | Compare effect of high dose vitamin D to the current standard vitamin D treatment administration algorithm on PRAI questionnaire results in young women with non-metastatic breast cancer who receive systemic therapy. |
| Overall satisfaction with pain control over time | 18 months | Compare effect of high dose vitamin D to the current standard vitamin D treatment administration algorithm on overall satisfaction with pain control in young women with non-metastatic breast cancer who receive systemic therapy. |
| Skeletal complications over time | 18 months | Compare effect of high dose vitamin D to the current standard vitamin D treatment administration algorithm on skeletal complications in young women with non-metastatic breast cancer who receive systemic therapy. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Vitamin D administration | 18 months | Descriptively summarize vitamin D administration for the high dose vitamin D arm and for the current standard vitamin D treatment administration algorithm in young women with non-metastatic breast cancer who receive systemic therapy. |
| Adverse events of special interest | 19 months | Compare effect of high dose vitamin D to the current standard vitamin D treatment administration algorithm on adverse events of special interest (vitamin D related headaches, irritability, spasticity, nausea, vomiting, and hypercalcemia) in young women with non-metastatic breast cancer who receive systemic therapy. |
| Adverse events of special interest leading to vitamin D dose modifications or discontinuations | 18 months | Compare effect of high dose vitamin D to the current standard vitamin D treatment administration algorithm on adverse events of special interest (vitamin D related headaches, irritability, spasticity, nausea, vomiting, and hypercalcemia) that results in vitamin D dose modifications or discontinuations in young women with non-metastatic breast cancer who receive systemic therapy. |
| Serious adverse events | 19 months | Compare effect of high dose vitamin D to the current standard vitamin D treatment administration algorithm on serious adverse events in young women with non-metastatic breast cancer who receive systemic therapy. |
| Treatment discontinuation due to vitamin D non-compliance | 18 months | Compare effect of high dose vitamin D to the current standard vitamin D treatment administration algorithm on treatment discontinuation due to vitamin D intake non-compliance. |
Countries
United States
Outcome results
None listed