Effects of Vitamin D in Patients With Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Other: Placebo; Drug: Vitamin D3

• Registration Number: NCT01948128
• Lead Sponsor: Ottawa Hospital Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-18
• Study First Submitted QC: 2013-09-18
• Study First Posted: 2013-09-23
• Study Start: 2013-10
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-02
• Last Update Posted: 2016-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 83

Inclusion Criteria

1. 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
2. Age ≥18 years
3. Clinically palpable tumour(s) (greater than or equal to 2 cm)
4. Normal serum and urine calcium and serum PTH values at baseline (as defined by Ottawa Hospital)
5. Written informed consent for study

Exclusion Criteria

1. Patients with recurrent or metastatic breast cancer
2. History of neoadjuvant hormonal therapy, chemotherapy, or radiation therapy in the last 6 months for their breast cancer or any other cancer treatment
3. ECOG performance Status > 2
4. Hypercalciuria on initial baseline urine, defined as Ca/Creatinine Ratio> 1.0
5. Current or previous history of urolithiasis or hyperparathyroidism
6. 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)
7. History of granulomatous disease such as tuberculosis or sarcoidosis.
8. Intake of Vitamin D (cholecalciferol) supplement ≥ 2000 IU/day within the last 2 months
9. Inability to comply with a study protocol in the opinion of the investigator (such as abuse of alcohol, drugs or psychotic states).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo taken daily by mouth
Vitamin D3	Vitamin D3	Vitamin D3 40,000 iu per day by mouth

Primary Outcome Measures

Name	Time	Method
Pre and post vitamin D administration Ki67 levels and Caspase 3 levels (as assessed according to the apoptosis assay)	baseline and 2-8 weeks from baseline	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.

Secondary Outcome Measures

Name	Time	Method
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	Participant will have Serum levels of 25-0HD and in vivo breast cancer tissue levels of 1,25(OH) taken at baseline and surgery

Trial Locations

Locations (1)

The Ottawa Hospital Woman's Breast Health Centre; 🇨🇦 Ottawa, Ontario, Canada