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

Breast Cancer Clinical Trial

— VITACAL  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01480869
• Other study ID #: VITACAL
• Secondary ID: VA 2010/122010-0
• Status: Completed
• Phase: Phase 3
• Start date: July 2011
• Est. completion date: December 2014

Study information

• Verified date: July 2015
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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) ………….

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• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Vitamin D Deficiency

Intervention

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

Locations

Country	Name	City	State
France	CRLC Val d'Aurelle-Paul Lamarque	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the increase in normalization of serum vitamin D level	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.	6 months
Secondary	Baseline vitamin D/calcium status in this patient population		Baseline
Secondary	Normalization rate of serum 25-OHD level		12, 18 and 24 months
Secondary	Normalization rate of serum 25-OHD level in control patients who shift to experimental strategy		6 months after crossover
Secondary	Clinical and biological tolerance profile	According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.0	During treament administration (can last up to 24 months)
Secondary	Treatment compliance	Treatment compliance will be assessed using a patient record book	During treatment administration (can last up to 24 months)
Secondary	Quality of life	Quality of life is assessed using the EORTC QLQ-C30 questionnaire	24 months
Secondary	Impact of study treatments on bone and joint pains induced by aromatase inhibitors		During treatment administration (can last up to 24 months)
Secondary	Changes in vitamin and calcium biological markers		Up to 24 months
Secondary	Predictive value of individual biomarkers		Up to 24 months