Breast Cancer
Conditions
Keywords
Breast cancer, Vitamin D supplementation, in neoadjuvant, adjuvant setting
Brief summary
The purpose of this study is to compare normalization of vitamin D serum level after 6 months of vitamin D supplementation adjusted to baseline vitamin D serum level vs.conventional vitamin D supplementation.
Interventions
Tablet to suck: calcium 500 mg bid, cholecalciferol 200 IU bid
Sponsors
Institut du Cancer de Montpellier - Val d'Aurelle
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Breast adenocarcinoma treated by neoadjuvant or adjuvant chemotherapy within 12 months prior to study enrollment * WHO performance status 0-1 * Age ≥18 years old * Affiliation to a social security regime or beneficiary of equivalent social protection * Written informed consent provided before any study specific procedures Complementary inclusion criterion for randomization \- Proved vitamin D deficiency as defined by serum vitamin D level lower than 30 ng/ml (75 nmol/L).
Exclusion criteria
* Metastatic disease * History or presence of any other malignancy (except curatively treated nonmelanoma skin cancer or in situ cervix carcinoma) …………. traités dans les 5 ans précédents. * Contraindication to calcium or cholecalciferol * Known severe hypersensitivity to vitamin D or to calcium supplementation or to one of the excipients. * Disease and/or medical conditions accompanied by hypercalcaemia and/or hypercalciuria * Calcium lithiasis and tissue calcification * Hypervitaminosis D * Presence of significant comorbidities: i) Uncontrolled endocrine disease ii) Known disorders of calcium phophorus laboratory testing iii) Proved osteopenia or osteoporosis requiring vitamin D and calcium supplements * Concomitant treatment with other experimental products or another vitamin D calcium treatment * Pregnancy, breastfeeding or of reproductive potential not using an effective contraceptive method * Legal inability or restricted legal ability. Medical or psychological conditions not allowing proper study completion or informed consent signature
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the increase in normalization of serum vitamin D level | 6 months | To compare the increase in normalization of serum vitamin D level adjusted to baseline level in patients receiving either vitamin D supplementation tailored to vitamin D deficiency or conventional vitamin D supplementation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Baseline vitamin D/calcium status in this patient population | Baseline | — |
| Normalization rate of serum 25-OHD level | 12, 18 and 24 months | — |
| Normalization rate of serum 25-OHD level in control patients who shift to experimental strategy | 6 months after crossover | — |
| Clinical and biological tolerance profile | During treament administration (can last up to 24 months) | According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.0 |
| Treatment compliance | During treatment administration (can last up to 24 months) | Treatment compliance will be assessed using a patient record book |
| Quality of life | 24 months | Quality of life is assessed using the EORTC QLQ-C30 questionnaire |
| Impact of study treatments on bone and joint pains induced by aromatase inhibitors | During treatment administration (can last up to 24 months) | — |
| Changes in vitamin and calcium biological markers | Up to 24 months | — |
| Predictive value of individual biomarkers | Up to 24 months | — |
Countries
France
Outcome results
None listed