NCT01948128

Brief Summary

This protocol is a randomized, phase 2 "window of opportunity" trial assessing the biological effects of short term oral vitamin D administration on breast cancer clinical and translational markers in patients awaiting surgery at the Ottawa Hospital. It takes advantage of the current wait times (2-8 weeks) for breast cancer surgery as a "window of opportunity" to rapidly assess biological changes with vitamin D intake.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Oct 2013

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 23, 2013

Completed
8 days until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

February 3, 2016

Status Verified

February 1, 2016

Enrollment Period

1.9 years

First QC Date

September 18, 2013

Last Update Submit

February 2, 2016

Conditions

Breast Cancer

Keywords

Breast

Outcome Measures

Primary Outcomes (1)

  • Pre and post vitamin D administration Ki67 levels and Caspase 3 levels (as assessed according to the apoptosis assay)

    Participants will have Ki67 and Caspase 3 levels performed on the tissue that was used to initially diagnose breast cancer. Those levels will then be compared to the tissue acquired at the time of surgery which will occur 2-8 weeks from diagnosis.

    baseline and 2-8 weeks from baseline

Secondary Outcomes (1)

  • Serum levels of 25-0HD and in vivo breast (cancer and non cancer) tissue levels of 1,25(OH)

    Baseline and 2-8 weeks from baseline at the time of surgery

Study Arms (2)

Vitamin D3

EXPERIMENTAL

Vitamin D3 40,000 iu per day by mouth

Drug: Vitamin D3

Placebo

PLACEBO COMPARATOR

Placebo taken daily by mouth

Other: Placebo

Interventions

Vitamin D3DRUG

Participants will take 4 capsules of Vitamin D which equals 40,000 IU by mouth daily during the wait time between diagnosis and surgery.

Also known as: Vitamin D, cholecalciferol
Vitamin D3
PlaceboOTHER

Participants will take 4 capsules of placebo by mouth daily during the wait time between diagnosis and surgery.

Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed female primary breast cancer patients whose surgery is planned for the next 2-8 weeks without neoadjuvant therapy as assessed by multidisciplinary team
  • Age ≥18 years
  • Clinically palpable tumour(s) (greater than or equal to 2 cm)
  • Normal serum and urine calcium and serum PTH values at baseline (as defined by Ottawa Hospital)
  • Written informed consent for study

You may not qualify if:

  • Patients with recurrent or metastatic breast cancer
  • History of neoadjuvant hormonal therapy, chemotherapy, or radiation therapy in the last 6 months for their breast cancer or any other cancer treatment
  • ECOG performance Status \> 2
  • Hypercalciuria on initial baseline urine, defined as Ca/Creatinine Ratio\> 1.0
  • Current or previous history of urolithiasis or hyperparathyroidism
  • Abnormal hepatic function according to Ottawa Hospital norms (Total Bilirubin \>2x upper limit of normal, ALT/AST \>3x upper limit of normal)and/or abnormal renal function (Creatinine \> 150 µmol/L)
  • History of granulomatous disease such as tuberculosis or sarcoidosis.
  • Intake of Vitamin D (cholecalciferol) supplement ≥ 2000 IU/day within the last 2 months
  • Inability to comply with a study protocol in the opinion of the investigator (such as abuse of alcohol, drugs or psychotic states).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital Woman's Breast Health Centre

Ottawa, Ontario, Canada

Location

Related Publications (1)

  • Arnaout A, Robertson S, Pond GR, Vieth R, Jeong A, Hilton J, Ramsey T, Clemons M. Randomized window of opportunity trial evaluating high-dose vitamin D in breast cancer patients. Breast Cancer Res Treat. 2019 Nov;178(2):347-356. doi: 10.1007/s10549-019-05392-9. Epub 2019 Aug 9.

    PMID: 31399931DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

CholecalciferolVitamin D

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsSecosteroidsMembrane LipidsLipids

Study Officials

  • Angel Arnaout, Dr.

    The Ottawa Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2013

First Posted

September 23, 2013

Study Start

October 1, 2013

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

February 3, 2016

Record last verified: 2016-02

Locations

CA(1)