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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
calcium and cholecalciferol
calcium and cholecalciferol
Sponsored by
Institut du Cancer de Montpellier - Val d'Aurelle
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast cancer, Vitamin D supplementation, in neoadjuvant, adjuvant setting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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:

    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

Sites / Locations

  • CRLC Val d'Aurelle-Paul Lamarque

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional vitamin D and calcium supplementation

vitamin D supplementation tailored to vitamin D deficiency

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Baseline vitamin D/calcium status in this patient population
Normalization rate of serum 25-OHD level
Normalization rate of serum 25-OHD level in control patients who shift to experimental strategy
Clinical and biological tolerance profile
According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.0
Treatment compliance
Treatment compliance will be assessed using a patient record book
Quality of life
Quality of life is assessed using the EORTC QLQ-C30 questionnaire
Impact of study treatments on bone and joint pains induced by aromatase inhibitors
Changes in vitamin and calcium biological markers
Predictive value of individual biomarkers

Full Information

First Posted
November 24, 2011
Last Updated
September 6, 2019
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
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1. Study Identification

Unique Protocol Identification Number
NCT01480869
Brief Title
Study of Vitamin D Supplementation Tailored to Vitamin D Deficiency in Breast Cancer Patients
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, Vitamin D supplementation, in neoadjuvant, adjuvant setting

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
215 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional vitamin D and calcium supplementation
Arm Type
Active Comparator
Arm Description
Conventional vitamin D and calcium supplementation with 2 daily OROCAL VITAMINE D3® (500 mg calcium/200 IU cholecalciferol) tablets.
Arm Title
vitamin D supplementation tailored to vitamin D deficiency
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
calcium and cholecalciferol
Intervention Description
Tablet to suck: calcium 500 mg bid, cholecalciferol 200 IU bid
Intervention Type
Drug
Intervention Name(s)
calcium and cholecalciferol
Intervention Description
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
Primary Outcome Measure Information:
Title
To evaluate the increase in normalization of serum vitamin D level
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Baseline vitamin D/calcium status in this patient population
Time Frame
Baseline
Title
Normalization rate of serum 25-OHD level
Time Frame
12, 18 and 24 months
Title
Normalization rate of serum 25-OHD level in control patients who shift to experimental strategy
Time Frame
6 months after crossover
Title
Clinical and biological tolerance profile
Description
According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.0
Time Frame
During treament administration (can last up to 24 months)
Title
Treatment compliance
Description
Treatment compliance will be assessed using a patient record book
Time Frame
During treatment administration (can last up to 24 months)
Title
Quality of life
Description
Quality of life is assessed using the EORTC QLQ-C30 questionnaire
Time Frame
24 months
Title
Impact of study treatments on bone and joint pains induced by aromatase inhibitors
Time Frame
During treatment administration (can last up to 24 months)
Title
Changes in vitamin and calcium biological markers
Time Frame
Up to 24 months
Title
Predictive value of individual biomarkers
Time Frame
Up to 24 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CRLC Val d'Aurelle-Paul Lamarque
City
Montpellier
ZIP/Postal Code
34298
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
27029707
Citation
Jacot W, Firmin N, Roca L, Topart D, Gallet S, Durigova A, Mirr S, Abach L, Pouderoux S, D'Hondt V, Bleuse JP, Lamy PJ, Romieu G. Impact of a tailored oral vitamin D supplementation regimen on serum 25-hydroxyvitamin D levels in early breast cancer patients: a randomized phase III study. Ann Oncol. 2016 Jul;27(7):1235-41. doi: 10.1093/annonc/mdw145. Epub 2016 Mar 30.
Results Reference
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Study of Vitamin D Supplementation Tailored to Vitamin D Deficiency in Breast Cancer Patients

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