Breast Cancer Clinical Trial
Official title:
An Exploratory Pilot Study of Vitamin D Supplementation in Women With DCIS and/or LCIS
Verified date | October 2020 |
Source | Inova Health Care Services |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine the safety and usefulness of oral Vitamin D supplementation in subjects with in situ carcinoma. More specifically, this study is being done to (1) understand the effect of Vitamin D supplementation on behavior of breast cancer cells and (2) the development of invasive breast cancer disease.
Status | Terminated |
Enrollment | 8 |
Est. completion date | January 2019 |
Est. primary completion date | January 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Subjects must have a tissue diagnosis of lobular carcinoma in situ or ductal carcinoma in situ and being scheduled to undergo excision of their cancer - Subjects must be female at least 18 years of age - Subjects must have a signed consent - Normal liver function based on (total bilirubin and AST <1.5 x Upper Limit of Normal) - Serum creatinine < 2.0 mg/dL - Serum 25 (OH) D levels < 50 ng/ml - Calcium within the normal range (8.5-10.2 mg/dL) - ECOG performance status 0-2 - Are able to swallow and retain oral medication - Subjects should be willing to abstain from use of hormonal therapies (e.g. hormone replacement therapy, oral contraceptive pills, hormone-containing IUDs, and E-string) Exclusion Criteria: - Patient desires not to participate in the study - Inability to give consent - Current use of hormone-containing forms of birth control such as implants (i.e. Norplants, or injectables (i.e. depo-provera) - Currently lactating - Patients with history of renal or hepatic insufficiency - Used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study medication - History of granulomatous disease such as tuberculosis or sarcoidosis - History of Vitamin D supplementation > 2000 IU/day within the last 2 months - History of hypoparathyroidism |
Country | Name | City | State |
---|---|---|---|
United States | Inova Schar Cancer Institute | Fairfax | Virginia |
Lead Sponsor | Collaborator |
---|---|
Inova Health Care Services |
United States,
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* Note: There are 32 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ki 67 Measured | The proliferation index measured by Ki67 will be described for both baseline (pre) and surgical (post) vitamin D supplementation. A paired t-test or the non-parametric Wilcoxon signed-rank test will be used when appropriate to compare patients' outcome between baseline and after-treatment. | 28 days +/- 3 days from Day 1 of treatment | |
Secondary | Levels of Proteins of the Autophagy Pathway, LC3B | Descriptive statistics (N, mean, median, Min, Max, STD for continuous variables, and N, proportion for categorical variables) will be used to summarize patients' demographics as well as lab results. . A paired t-test or the non-parametric Wilcoxon signed-rank test will be used when appropriate to compare patients' outcome between baseline and after-treatment. A p-value of <0.05 will be considered statistically significant. | 28 days +/- 3 days from Day 1 of treatment | |
Secondary | Levels of Proteins of the Autophagy Pathway, ATG7 | Descriptive statistics (N, mean, median, Min, Max, STD for continuous variables, and N, proportion for categorical variables) will be used to summarize patients' demographics as well as lab results. . A paired t-test or the non-parametric Wilcoxon signed-rank test will be used when appropriate to compare patients' outcome between baseline and after-treatment. A p-value of <0.05 will be considered statistically significant. | 28 days +/- 3 days from Day 1 of treatment | |
Secondary | Levels of the Calcium Transport Proteins, PMCA2 | Descriptive statistics (N, mean, median, Min, Max, STD for continuous variables, and N, proportion for categorical variables) will be used to summarize patients' demographics as well as lab results. A paired t-test or the non-parametric Wilcoxon signed-rank test will be used when appropriate to compare patients' outcome between baseline and after-treatment. A p-value of <0.05 will be considered statistically significant. | 28 days +/- 3 days from Day 1 of treatment | |
Secondary | HER2 Localization | Descriptive statistics (N, mean, median, Min, Max, STD for continuous variables, and N, proportion for categorical variables) will be used to summarize patients' demographics as well as lab results. A paired t-test or the non-parametric Wilcoxon signed-rank test will be used when appropriate to compare patients' outcome between baseline and after-treatment. A p-value of <0.05 will be considered statistically significant. | 28 days +/- 3 days from Day 1 of treatment |
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