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| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
| BTR Group | INDUSTRY |
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The primary purpose is to determine if high dose vitamin D3 reduces the incidence of musculoskeletal symptoms associated with the aromatase inhibitor letrozole in women with early stage breast cancer and low serum vitamin D levels.
The primary hypothesis is that high dose vitamin D3 plus standard dose vitamin D3 prevents the worsening of musculoskeletal symptoms when compared to a standard dose vitamin D3 treatment. This protocol will examine the relationship between vitamin D levels (25-hydroxyvitamin D) and various quality of life measures in women being treated with letrozole as standard care for early stage breast cancer. All subjects received letrozole and a standard dose of vitamin D3 (600 IU daily). Randomization was between high dose vitamin D3 (30,000 IU once per week) vs. a blinded, matched placebo,
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Dose Vitamin D | Experimental | High Dose Vitamin D3 capsule (3 x 10,000 IU capsules weekly). All subjects also received standard dose vitamin D3 (600 IU daily) and letrozole (2.5 mg daily). |
|
| Placebo | Placebo Comparator | Placebo matched for High Dose Vitamin D3 capsules. All subjects also received standard dose vitamin D3 (600 IU daily) and letrozole (2.5 mg daily). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Dose Vitamin D | Dietary Supplement | High Dose Vitamin D3 (3 capsules of 10,000 IU) weekly for 24 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Worsening of Musculoskeletal Symptoms (MS) | Worsening of Musculoskeletal Symptoms (MS) is defined as any one of the following three events: (a) an increase by at least 0.25 in the Health Assessment Questionnaire II (HAQ II, a measure of disability from joint pain) score, (b) an increase in patient reported severity of joint and/or muscle pain, or (c) discontinuation from trial prior to 24 weeks specifically because of problems with musculoskeletal symptoms. | Change from Baseline to 24 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qamar J Khan, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Westwood | Kansas | 66205 | United States | ||
| Cancer Centers of Kansas, P.A. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo (3 capsules of matching placebo given weekly) along with standard of care medication (Standard Dose Vitamin D3, 600 IU of vitamin D3 daily; letrozole, 2.5 mg daily) for 24 weeks. |
| FG001 | Vitamin D | High Dose Vitamin D3 (3 capsules of 10,000 IU given weekly) along with standard of care medication (Standard Dose Vitamin D3, 600 IU of vitamin D3 daily; letrozole, 2.5 mg daily) for 24 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo (3 capsules of matching placebo weekly) along with standard of care medication (Standard Dose Vitamin D3, 600 IU of vitamin D3 daily; letrozole, 2.5 mg daily) for 24 weeks. |
| BG001 | Vitamin D |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Worsening of Musculoskeletal Symptoms (MS) | Worsening of Musculoskeletal Symptoms (MS) is defined as any one of the following three events: (a) an increase by at least 0.25 in the Health Assessment Questionnaire II (HAQ II, a measure of disability from joint pain) score, (b) an increase in patient reported severity of joint and/or muscle pain, or (c) discontinuation from trial prior to 24 weeks specifically because of problems with musculoskeletal symptoms. | Subjects available for analysis included those that had completed the entire study; plus three subjects that had dropped out early specifically because of side effects related to musculoskeletal symptoms (one of the endpoints). | Posted | Number | participants | Change from Baseline to 24 Weeks |
|
1 year, 9 months
Adverse events were collected either at routine clinical visits or by patient report during periodic phone calls.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo (3 capsules of matching placebo) along with standard of care medication (Standard Dose Vitamin D3; 600 IU of vitamin D3 daily) given weekly for 24 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Changes | Cardiac disorders | CTCAE version 3.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Nervous system disorders | CTCAE version 3.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bruce Kimler | University of Kansas Medical Center | (913) 588-4523 | bkimler@kumc.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D002762 | Cholecalciferol |
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Placebo | Dietary Supplement | Placebo comparator |
|
| Standard Dose Vitamin D3 | Dietary Supplement | Standard Dose Vitamin D3 (600 IU of vitamin D3 daily) |
|
| Letrozole 2.5mg | Drug | All subjects received letrozole as standard of care. |
|
| Wichita |
| Kansas |
| 67214 |
| United States |
High Dose Vitamin D3 (3 capsules of 10,000 IU weekly) along with standard of care medication (Standard Dose Vitamin D3, 600 IU of vitamin D3 daily; letrozole, 2.5 mg daily) for 24 weeks.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Vitamin D | High Dose Vitamin D3 (3 capsules of 10,000 IU) capsules along with standard of care medication standard of care medication (Standard Dose Vitamin D3; 600 IU of vitamin D3 daily) given weekly for 24 weeks |
|
|
| 3 |
| 80 |
| 67 |
| 80 |
| EG001 | Vitamin D | High Dose Vitamin D3 (3 capsules of 10,000 IU) capsules along with standard of care medication standard of care medication (Standard Dose Vitamin D3; 600 IU of vitamin D3 daily) given weekly | 3 | 80 | 37 | 80 |
| CNS Ischemia | Nervous system disorders | CTCAE version 3.0 | Non-systematic Assessment |
|
| Colitis | Gastrointestinal disorders | CTCAE version 3.0 | Non-systematic Assessment |
|
| Hemolysis | Blood and lymphatic system disorders | CTCAE version 3.0 | Non-systematic Assessment |
|
| Supraventricular arryhthmia | Cardiac disorders | CTCAE version 3.0 | Non-systematic Assessment |
|
| Wound Complications | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | Non-systematic Assessment |
|
| Fatigue | Nervous system disorders | CTCAE version 3.0 | Non-systematic Assessment |
|
| Hot Flashes | General disorders | CTCAE version 3.0 | Non-systematic Assessment |
|
| Joint Function | Musculoskeletal and connective tissue disorders | CTCAE version 3.0 | Non-systematic Assessment |
|
| Joint Pain | Musculoskeletal and connective tissue disorders | CTCAE version 3.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE version 3.0 | Non-systematic Assessment |
|
| Pain - Back | Nervous system disorders | CTCAE version 3.0 | Non-systematic Assessment |
|
| Pain - Hip | Nervous system disorders | CTCAE version 3.0 | Non-systematic Assessment |
|
| Pain - Shoulder | Nervous system disorders | CTCAE version 3.0 | Non-systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D002782 |
| Cholestenes |
| D002776 | Cholestanes |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |