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Completed

NCT Number: NCT01948128

Effects of Vitamin D in Patients With Breast Cancer

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

The Ottawa Hospital Woman's Breast Health Centre

Ottawa, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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).

Treatment and study plan

Vitamin D3

Drug

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 names: Vitamin D, cholecalciferol

Placebo

Other

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

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Collaborators

  • Canadian Breast Cancer Foundation

Registry information

Official study 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

Acronym: OTT 12-06

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 23, 2013
Registry last updated
Feb 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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