Vitamin D supplementation to breast cancer survivors with joint pain on treatment with an aromatase inhibitor to reduce their risk for breast cancer relapse. The patients is its own control and pain is measured before and after 12 weeks of vitamin D supplementatio

Phase 1

• Conditions: Breast cancer survivors on adjuvant treatment with an aromatase inhibitor having joint pain; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-001022-17-SE
• Lead Sponsor: Breastcentre, Capio St Gorans Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-13
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1. Breast cancer survivors at the Breastcentre, St Gorans Hospital on adjuvant endocrine treatment with an aromatase inhibitor having joint pain
2. The patient should have no cognitive failure, being able to comprehend oral and written information about the study.
3. 25 OHD < 50 nmol/L.
4. Women aged =18.
5. Signed 'informed consent'.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1. Ongoing vitamin D or calcium supplementation at the time for inclusion.
2. Serum level of 25-OH vitamin D3 >/= 50 nmol/L.
3. Known sarkoidosis.
4. Treament with tizzies.
5. Primary hyperparathyroidism.
6. Hypercalcaemia (verified by a laboratory result younger than 2 month).
7. History of kidney stones.
8. Hypersensivity to cholecalciferol and/or any of the excipients.
9. Other criteria that could jeopardize the study or its intention as judged by the investigator.
10. Not being able to perform EORTC-QLQ-BR23 or Brief Pain Inventory Short Form.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified