Effects of Vitamin D in Patients With Breast Cancer

Breast Cancer Clinical Trial

— OTT 12-06  

Official title:

A Phase 2 Randomized, Double-blind, Window of Opportunity Trial Evaluating Clinical and Correlative Effects of Vitamin D in Patients With Breast Cancer. The ICARUS Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01948128
• Other study ID #: 20120362-2OH
• Status: Completed
• Phase: Phase 2
• First received: September 18, 2013
• Last updated: February 2, 2016
• Start date: October 2013
• Est. completion date: September 2015

Study information

• Verified date: February 2016
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCanada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Vitamin D3
Participants will take 4 capsules of Vitamin D which equals 40,000 IU by mouth daily during the wait time between diagnosis and surgery.

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

Locations

Country	Name	City	State
Canada	The Ottawa Hospital Woman's Breast Health Centre	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Canadian Breast Cancer Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Serum levels of 25-0HD and in vivo breast (cancer and non cancer) tissue levels of 1,25(OH)	Participant will have Serum levels of 25-0HD and in vivo breast cancer tissue levels of 1,25(OH) taken at baseline and surgery	Baseline and 2-8 weeks from baseline at the time of surgery	No