Study of Vitamin D Supplementation Tailored to Vitamin D Deficiency in Breast Cancer Patients

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Drug: calcium and cholecalciferol

• Registration Number: NCT01480869
• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-11-24
• Study First Submitted QC: 2011-11-28
• Study First Posted: 2011-11-29
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-07
• Last Update Submitted: 2019-09-06
• Last Update Posted: 2019-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 215

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional vitamin D and calcium supplementation	calcium and cholecalciferol	Conventional vitamin D and calcium supplementation with 2 daily OROCAL VITAMINE D3® (500 mg calcium/200 IU cholecalciferol) tablets.
vitamin D supplementation tailored to vitamin D deficiency	calcium and cholecalciferol	Conventional calcium supplementation with 2 daily OROCAL 500® (500 mg calcium) tablets to suck + vitamin D3 supplementation (UVÉDOSE®, cholecalciferol, 100 000 IU drinkable solution, 2 ml vial) whose schedule of administration depends on vitamin deficiency level: * 100 000 IU of vitamin D3 at D1, D15, D28 and D43 if 25OHD level \< 10 ng/mL * 100 000 IU of vitamin D3 at D1, D15, D28 if 10 ng/mL ≤ 25OHD level \< 20 ng/mL * 100 000 IU of vitamin D3 at D1 if 20 ng/mL ≤ 25OHD level \< 30 ng/mL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Predictive value of individual biomarkers	Up to 24 months
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
Changes in vitamin and calcium biological markers	Up to 24 months
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)

Trial Locations

Locations (1)

CRLC Val d'Aurelle-Paul Lamarque; 🇫🇷 Montpellier, France