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Vitamin D Supplementation in Women With DCIS and/or LCIS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02936999
Recruitment Status : Terminated
First Posted : October 18, 2016
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Inova Health Care Services

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Cholecalciferol Not Applicable

Detailed Description:

In vitro, calcitriol, the most potent metabolite of vitamin D, inhibits a variety of cellular pathways that promote cell proliferation and survival. Vitamin D has been shown to reduce the growth of breast cancer precursor cells in cell culture studies. In animal models Vitamin D has been shown to prevent the growth and progression of transplanted cell lines MCF710A, which is a model of pre-invasive cancer. Serum Vitamin D level deficiency correlates with an increased risk of breast cancer, and reduced survival of breast cancer patients. Vitamin D is also recognized to have effects on immune cell function and autoimmunity. The safety profile of oral Vitamin D, and its metabolite calcitriol, was well established for moderate term and acute therapy worldwide. Potential additional primary and secondary benefits of vitamin D are a) the suppression of carcinogen-induced transformation or progression of breast epithelium, and b) the enhancement of innate immune defense of pre-invasive breast cancer lesions, and c) its qualification as a combination therapy when combined with other neoadjuvant therapies for DCIS.

Patients who have been diagnosed by core biopsy with carcinoma in situ, ductal or lobular, will be evaluated for vitamin d supplementation. Patients with vitamin d levels less than 50 will be eligible for participation. They will receive a one month (30 days) schedule of vitamin D supplementation and then proceed with the standard of care of surgical excision. Immunohistochemistry studies will be performed on the diagnostic core biopsy and the surgical specimen to evaluate the impact of vitamin d supplementation on: the proliferative index-ki67, proliferative marker- PCNA, proteins of the autophagy pathway (LC3B, ATG7), her2 localization, and levels of PMCA2 - calcium efflux channel.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Exploratory Pilot Study of Vitamin D Supplementation in Women With DCIS and/or LCIS
Actual Study Start Date : August 2016
Actual Primary Completion Date : January 2019
Actual Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Experimental: Vitamin D3
Patients will be dispensed cholecalciferol, 32 capsules/bottle of 1cap/4000 IU PO QD on Day 1 visit to take home. Bottle must be labeled with instructions on how to take the drug and the assigned patient ID number. Patients will be instructed to take 1 capsule per day, with water, for 29 days using the dispensed study bottle. They will be instructed to stop taking their daily vitamin D3 dose after 30 days of treatment. A study drug diary will be provided at Day 1 visit and patients will be instructed to complete the study drug diary daily from Day 2 to Day 30. Patient's report of vitamin-D3 intake from the diary must be reconciled against the number of capsules returned at Day 30 visit.
Drug: Cholecalciferol
Cholecalciferol 100,000 IU followed by 4000 IU orally once daily for 30 days.
Other Name: Vitamin D3




Primary Outcome Measures :
  1. Ki 67 measured [ Time Frame: 28 days +/- 3 days from Day 1 of treatment ]
    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.


Secondary Outcome Measures :
  1. Levels of proteins of the autophagy pathway, LC3B [ Time Frame: 28 days +/- 3 days from Day 1 of treatment ]
    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.

  2. Levels of proteins of the autophagy pathway, ATG7 [ Time Frame: 28 days +/- 3 days from Day 1 of treatment ]
    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.

  3. Levels of the Calcium transport proteins, PMCA2 [ Time Frame: 28 days +/- 3 days from Day 1 of treatment ]
    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.

  4. HER2 localization [ Time Frame: 28 days +/- 3 days from Day 1 of treatment ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02936999


Locations
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United States, Virginia
Inova Schar Cancer Institute
Fairfax, Virginia, United States, 22031
Sponsors and Collaborators
Inova Health Care Services
Investigators
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Principal Investigator: Mary Wilkinson, MD Inova Schar Cancer Institute
Publications:

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Responsible Party: Inova Health Care Services
ClinicalTrials.gov Identifier: NCT02936999    
Other Study ID Numbers: 16-2399
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents