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 supplementation

Vitamin D supplementation to breast cancer patients with adjuvant endocrine treatment – An observational clinical study where the patient is its own control. - VIDEN

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001022-17-SE

Enrollment

Unknown

Registered

2017-03-13

Start date

2017-05-08

Completion date

Unknown

Last updated

2017-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer survivors on adjuvant treatment with an aromatase inhibitor having joint pain

Interventions

Trade Name: Detremin Pharmaceutical Form: Oral drops, solution

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to try the hypothesis that vitamin D supplementation reduce joint pain in breast cancer survivors on adjuvant treatment with an aromatase inhibitor;Secondary Objective: The secondary objectives is to try the hypothesis that vitamin D supplementation in breast cancer survivors on adjuvant treatment with an aromatase inhibitor reduce fatigue and depression and improve quality of life. The effect on the vitamin D levels in serum after 12 weeks of treatment will also be studied. The safety objective is to verify that the use of vitamin D is safe and tolerable. ;Primary end point(s): Reduced joint and muscle pain during 12 weeks of vitamin D supplementation ;Timepoint(s) of evaluation of this end point: Measurement of joint and muscle pain with Brief Pain Inventory Short Form at inclusion and after 6 and 12 weeks.	—

Measure

Time frame

Main Objective: The primary objective is to try the hypothesis that vitamin D supplementation reduce joint pain in breast cancer survivors on adjuvant treatment with an aromatase inhibitor;Secondary Objective: The secondary objectives is to try the hypothesis that vitamin D supplementation in breast cancer survivors on adjuvant treatment with an aromatase inhibitor reduce fatigue and depression and improve quality of life. The effect on the vitamin D levels in serum after 12 weeks of treatment will also be studied. The safety objective is to verify that the use of vitamin D is safe and tolerable. ;Primary end point(s): Reduced joint and muscle pain during 12 weeks of vitamin D supplementation ;Timepoint(s) of evaluation of this end point: Measurement of joint and muscle pain with Brief Pain Inventory Short Form at inclusion and after 6 and 12 weeks.

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Secondary

Measure	Time frame
Secondary end point(s): 1. Improvement in quality of life measured with EORTC-QLQ-BR23 at screening and after 6 and 12 weeks 2. Improvement in fatigue and depression measured with patient reported Numeric score 0-10 at screening and after 6 and 12 weeks 3. Levels of 25-OHD in serum after 12 weeks of treatment. 4. The safety endpoint is the frequency of AE among all subjects and the levels of calcium in plasma and urine (selected patients) during the study period.;Timepoint(s) of evaluation of this end point: 1. Improvement in quality of life measured with EORTC-QLQ-BR23 at screening and after 6 an 12 weeks 2. Improvement in fatigue and depression measured with patient reported Numeric score 0-10 at screening and after 6 and 12 weeks 3. Levels of 25-OHD in serum after 12 weeks of treatment. 4. The safety endpoint is the frequency of AE among all subjects and the levels of calcium in plasma and urine (selected patients) during the study period at screening, at week 6 and 12.	—

Measure

Time frame

Secondary end point(s): 1. Improvement in quality of life measured with EORTC-QLQ-BR23 at screening and after 6 and 12 weeks 2. Improvement in fatigue and depression measured with patient reported Numeric score 0-10 at screening and after 6 and 12 weeks 3. Levels of 25-OHD in serum after 12 weeks of treatment. 4. The safety endpoint is the frequency of AE among all subjects and the levels of calcium in plasma and urine (selected patients) during the study period.;Timepoint(s) of evaluation of this end point: 1. Improvement in quality of life measured with EORTC-QLQ-BR23 at screening and after 6 an 12 weeks 2. Improvement in fatigue and depression measured with patient reported Numeric score 0-10 at screening and after 6 and 12 weeks 3. Levels of 25-OHD in serum after 12 weeks of treatment. 4. The safety endpoint is the frequency of AE among all subjects and the levels of calcium in plasma and urine (selected patients) during the study period at screening, at week 6 and 12.

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Countries

Sweden

Contacts

Public ContactJenny Bergqvist

Breastcentre, Capio St Gorans Hospital

jenny.bergqvist@ki.se+46722339357

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026