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| ID | Type | Description | Link |
|---|---|---|---|
| 00055909 | Other Identifier | Advarra IRB | |
| LCI-BRE-VITD-001 | Other Identifier | LCI |
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| Name | Class |
|---|---|
| Atrium Health Levine Cancer Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Vit D | Experimental | High Dose Vitamin D |
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| SOC Vit D | Active Comparator | Standard of Care Vitamin D |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Dose Vitamin D | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline in bone mineral density (g/cm^2) from baseline to the Year 1 DEXA scan | 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. | 15 months (12 plus a +3 month calendar window) |
| Measure | Description | Time Frame |
|---|---|---|
| 25(OH) D level over time | 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. | 18 months |
| PRAI questionnaire results over time |
| Measure | Description | Time Frame |
|---|---|---|
| Vitamin D administration | 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. | 18 months |
| Adverse events of special interest |
Inclusion Criteria
Subject must meet all of the following applicable inclusion criteria to participate in this study:
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.
Age; 45 years at the time of consent
Female
Histological or cytological confirmation of breast cancer clinical or pathologic stages 0-III
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.
Systemic therapy for breast cancer is planned
As determined by the enrolling physician, ability of the subject to understand and comply with study procedures for the entire length of the study
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:
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| Name | Affiliation | Role |
|---|---|---|
| Arielle Heeke, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 29, 2023 | Sep 26, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Standard of Care Vitamin D | Dietary Supplement | 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. |
|
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. |
| 18 months |
| Overall satisfaction with pain control over time | 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. | 18 months |
| Skeletal complications over time | 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. | 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) in young women with non-metastatic breast cancer who receive systemic therapy. |
| 19 months |
| Adverse events of special interest leading to vitamin D dose modifications or discontinuations | 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. | 18 months |
| Serious adverse events | 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. | 19 months |
| Treatment discontinuation due to vitamin D non-compliance | 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. | 18 months |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |