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| Name | Class |
|---|---|
| University of Minnesota | OTHER |
| University of Southern California | OTHER |
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The Purpose of this study is to determine whether vitamin D3 supplements will decrease the muscle and bone pain that are reported by women who take Aromatase Inhibitors.
This project will determine the efficacy of vitamin D3 supplements for reducing side effects of treatment with aromatase inhibitors in women with a history of breast cancer that have no evidence of current disease. The aromatase inhibitors (AI) have become a critical component of adjuvant therapy for this population, but they cause bone pain, joint pain, joint stiffness, and muscle weakness in approximately 40% of patients. These symptoms, referred to as aromatase inhibitor-associated musculoskeletal symptoms (AIMSS), decrease quality of life and medication adherence. Identifying effective ways to decrease these symptoms may allow for longer and more adherent medication use and thus may improve disease-free survival. We hypothesize that vitamin D3 may decrease symptoms associated with the use of aromatase inhibitors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D3 4000 IU | Experimental |
| |
| Vitamin D3 600 IU | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Drug | Cholecalciferol capsule, 4000IU, daily for 6 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Musculoskeletal Symptom Sub-scale on the Breast Cancer Prevention Trial Symptom Scale | The MS subscale is a self-reported measure on a scale of 0 to 4, with lower score indicating less arthralgia/myalgia | baseline to 6 months |
| Change in Hand Grip Strength | baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PROMIS Physical Functioning Questionnaire | PROMIS measures physical functioning on the short form and higher scores reflect better physical functioning with 10 questions on daily activities of life on a Likert scale ranging from 5 (no problem performing activity) to 1 (cannot do activity). Range on this measure is from 50 (best)-10 (worst). | baseline to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alice C. Shapiro, PhD RD | Park Nicollet Health Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Park Nicollet Frauenshuh Cancer Center | Minneapolis | Minnesota | 55416 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26868123 | Result | Shapiro AC, Adlis SA, Robien K, Kirstein MN, Liang S, Richter SA, Lerner RE. Randomized, blinded trial of vitamin D3 for treating aromatase inhibitor-associated musculoskeletal symptoms (AIMSS). Breast Cancer Res Treat. 2016 Feb;155(3):501-12. doi: 10.1007/s10549-016-3710-6. Epub 2016 Feb 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin D3 4000 IU | Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months |
| FG001 | Vitamin D3 600 IU | Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin D3 4000 IU | Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months |
| BG001 | Vitamin D3 600 IU | Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Musculoskeletal Symptom Sub-scale on the Breast Cancer Prevention Trial Symptom Scale | The MS subscale is a self-reported measure on a scale of 0 to 4, with lower score indicating less arthralgia/myalgia | Only participants who provided data at both time points are included | Posted | Mean | Standard Deviation | units on a scale | baseline to 6 months |
|
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Adverse events were collected with regard to the organ system
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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 | Vitamin D3 4000 IU | Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Musculoskeletal | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alice Shapiro | HealthPartnersInstitute | 952-993-1704 | shapia@parknicollet.com |
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| ID | Term |
|---|---|
| D063806 | Myalgia |
| D018771 | Arthralgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Vitamin D3 |
| Drug |
cholecalciferol capsule, 600 IU, daily for 6 months |
|
| Average Percent Adherence to Vitamin D Interventio | adherence measured with pill counts for the vitamin D at predesignated study timepoints: baseline (after run-in), 3 months and 6 months | average for all study ppts for: screening to baseline; baseline to 3 months; 3 month to 6 months |
| Serum Estradiol Concentrations | baseline and 6 months |
| Change in Steady State Concentrations of Serum Anastrazole and Letrozole | Difference in steady state concentrations in plasma from baseline to 6 months | baseline to 6 months |
| Whole Body Bone Mineral Density | GLM Mean and standard deviation of Whole Body Bone Mineral Density (grams/cm2) of Trial Participants by Treatment Arm after controlling for bisphosphonate use | From Baseline and 6 months of D3 supplementation |
| Vitamin D Binding Protein Genotype | Baseline |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Change in Hand Grip Strength | only data from participants that were collected at both time points is included | Posted | Mean | Standard Deviation | pounds | baseline to 6 months |
|
|
|
| Secondary | Change in PROMIS Physical Functioning Questionnaire | PROMIS measures physical functioning on the short form and higher scores reflect better physical functioning with 10 questions on daily activities of life on a Likert scale ranging from 5 (no problem performing activity) to 1 (cannot do activity). Range on this measure is from 50 (best)-10 (worst). | only data from participants with measures at both time points are included | Posted | Mean | Standard Deviation | units on a scale | baseline to 6 months |
|
|
|
| Secondary | Average Percent Adherence to Vitamin D Interventio | adherence measured with pill counts for the vitamin D at predesignated study timepoints: baseline (after run-in), 3 months and 6 months | Posted | Number | % of adherence for each treatment arm | average for all study ppts for: screening to baseline; baseline to 3 months; 3 month to 6 months |
|
|
|
| Secondary | Serum Estradiol Concentrations | only participants whose serum was obtained at both time points are included | Posted | Geometric Mean | Standard Error | pg/ml | baseline and 6 months |
|
|
|
| Secondary | Change in Steady State Concentrations of Serum Anastrazole and Letrozole | Difference in steady state concentrations in plasma from baseline to 6 months | Only study participants with baseline and 6 month blood samples available were analyzed | Posted | Mean | Standard Deviation | mg/L | baseline to 6 months |
|
|
|
| Secondary | Whole Body Bone Mineral Density | GLM Mean and standard deviation of Whole Body Bone Mineral Density (grams/cm2) of Trial Participants by Treatment Arm after controlling for bisphosphonate use | Posted | Geometric Least Squares Mean | Standard Deviation | gm/cm2 | From Baseline and 6 months of D3 supplementation |
|
|
|
| Secondary | Vitamin D Binding Protein Genotype | Due to funding limitations, this secondary aim was not collected and analyzed in these groups | Posted | Baseline |
|
|
| 0 |
| 57 |
| 35 |
| 57 |
| EG001 | Vitamin D3 600 IU | Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months | 0 | 56 | 32 | 56 |
| Gastrointestinal complaints | Gastrointestinal disorders | Non-systematic Assessment |
|
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Surgical and medical procedures | Surgical and medical procedures | Non-systematic Assessment |
|
| Nervous system disorders | Nervous system disorders | Non-systematic Assessment |
|
| Respiratory | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Skin problems | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Cardiac | Cardiac disorders | Non-systematic Assessment |
|
| General | General disorders | Non-systematic Assessment |
|
| Reproductive and breast issues | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Injuries | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
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| D059352 | Musculoskeletal Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007592 | Joint Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |