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

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle (Other)

Overall Status

Completed

CT.gov ID

NCT01480869

Collaborator

(none)

215

Enrollment

Location

Arms

Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: calcium and cholecalciferol Drug: calcium and cholecalciferol	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

215 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Randomized Phase III Trial Comparing Conventional Vitamin D Supplementation vs. Vitamin D Supplementation Tailored to Vitamin D Deficiency in Breast Cancer Patients Treated by Neoadjuvant or Adjuvant Chemotherapy.

Study Start Date :

Jul 1, 2011

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Conventional vitamin D and calcium supplementation Conventional vitamin D and calcium supplementation with 2 daily OROCAL VITAMINE D3® (500 mg calcium/200 IU cholecalciferol) tablets.	Drug: calcium and cholecalciferol Tablet to suck: calcium 500 mg bid, cholecalciferol 200 IU bid
Experimental: vitamin D supplementation tailored to vitamin D deficiency 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	Drug: calcium and cholecalciferol Tablet: calcium 500 mg bid + 2 ml drinkable solution cholecalciferol 100 000 IU whose schedule of administration depends on vitamin deficiency level: 100 000 IU of vitamin D3 at D1, D15, D28 and D43 if 25-OHD level < 10 ng/mL 100 000 IU of vitamin D3 at D1, D15, D28 if 10 ng/mL ≤ 25-OHD level < 20 ng/mL 100 000 IU of vitamin D3 at D1 if 20 ng/mL ≤ 25-OHD level < 30 ng/mL

Arm

Intervention/Treatment

Active Comparator: Conventional vitamin D and calcium supplementation

Conventional vitamin D and calcium supplementation with 2 daily OROCAL VITAMINE D3® (500 mg calcium/200 IU cholecalciferol) tablets.

Drug: calcium and cholecalciferol

Tablet to suck: calcium 500 mg bid, cholecalciferol 200 IU bid

Experimental: vitamin D supplementation tailored to vitamin D deficiency

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

Drug: calcium and cholecalciferol

Tablet: calcium 500 mg bid + 2 ml drinkable solution cholecalciferol 100 000 IU whose schedule of administration depends on vitamin deficiency level: 100 000 IU of vitamin D3 at D1, D15, D28 and D43 if 25-OHD level < 10 ng/mL 100 000 IU of vitamin D3 at D1, D15, D28 if 10 ng/mL ≤ 25-OHD level < 20 ng/mL 100 000 IU of vitamin D3 at D1 if 20 ng/mL ≤ 25-OHD level < 30 ng/mL

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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:

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