Overview

Effects of Vitamin D in Patients With Breast Cancer

Status:
Completed
Trial end date:
2015-09-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborator:
Canadian Breast Cancer Foundation
Treatments:
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Criteria
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).