Vitamin D Supplementation in Women With DCIS and/or LCIS

NCT02936999 | Terminated Early Phase 1 Results DMC FDA Drug

• 1 other identifier: 16-2399
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Levels of Proteins of the Autophagy Pathway, LC3B

  28 days +/- 3 days from Day 1 of treatment

• Levels of Proteins of the Autophagy Pathway, ATG7

  28 days +/- 3 days from Day 1 of treatment

• Levels of the Calcium Transport Proteins, PMCA2

  28 days +/- 3 days from Day 1 of treatment

• HER2 Localization

  28 days +/- 3 days from Day 1 of treatment

Study Arms (1)

Vitamin D3

EXPERIMENTAL

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

Interventions

Cholecalciferol DRUG

Cholecalciferol 100,000 IU followed by 4000 IU orally once daily for 30 days.

Also known as: Vitamin D3

Vitamin D3

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Inova Health Care Services: lead

Study Sites (1)

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

Location

Related Publications (32)

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MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Regulatory Research Coordinator
• Organization: Inova Health Services

elizabeth.gebregeorgis@inova.org

(571) 472-0239

Study Officials

• Mary Wilkinson, MD

  Inova Schar Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2016
• First Posted: October 18, 2016
• Study Start: August 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: December 16, 2020
• Results First Posted: December 16, 2020

Record last verified: 2020-10

Locations

US (1)