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Effects of Vitamin D in Patients With Breast Cancer (OTT 12-06)

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ClinicalTrials.gov Identifier: NCT01948128
Recruitment Status : Completed
First Posted : September 23, 2013
Last Update Posted : February 3, 2016
Sponsor:
Collaborator:
Canadian Breast Cancer Foundation
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Vitamin D3 Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : October 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vitamin D3
Vitamin D3 40,000 iu per day by mouth
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 Names:
  • Vitamin D
  • cholecalciferol

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01948128


Locations
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Canada, Ontario
The Ottawa Hospital Woman's Breast Health Centre
Ottawa, Ontario, Canada
Sponsors and Collaborators
Ottawa Hospital Research Institute
Canadian Breast Cancer Foundation
Investigators
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Principal Investigator: Angel Arnaout, Dr. The Ottawa Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01948128     History of Changes
Other Study ID Numbers: 20120362-2OH
First Posted: September 23, 2013    Key Record Dates
Last Update Posted: February 3, 2016
Last Verified: February 2016

Keywords provided by Ottawa Hospital Research Institute:
Breast

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents