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

This study is currently recruiting participants.
Verified November 2011 by Centre Val d'Aurelle - Paul Lamarque
Sponsor:
Information provided by (Responsible Party):
Centre Val d'Aurelle - Paul Lamarque
ClinicalTrials.gov Identifier:
NCT01480869
First received: November 24, 2011
Last updated: November 28, 2011
Last verified: November 2011
History of Changes
  Purpose

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 Intervention Phase
Breast Cancer
 Drug: calcium and cholecalciferol
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Val d'Aurelle - Paul Lamarque:

Primary Outcome Measures:
  • To evaluate the increase in normalization of serum vitamin D level [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Normalization rate of serum 25-OHD level [ Time Frame: 12, 18 and 24 months ] [ Designated as safety issue: No ]
  • Normalization rate of serum 25-OHD level in control patients who shift to experimental strategy [ Time Frame: 6 months after crossover ] [ Designated as safety issue: No ]
  • Clinical and biological tolerance profile [ Time Frame: During treament administration (can last up to 24 months) ] [ Designated as safety issue: Yes ]
    According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.0

  • Treatment compliance [ Time Frame: During treatment administration (can last up to 24 months) ] [ Designated as safety issue: No ]
    Treatment compliance will be assessed using a patient record book

  • Quality of life [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Quality of life is assessed using the EORTC QLQ-C30 questionnaire

  • Impact of study treatments on bone and joint pains induced by aromatase inhibitors [ Time Frame: During treatment administration (can last up to 24 months) ] [ Designated as safety issue: Yes ]
  • Changes in vitamin and calcium biological markers [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
  • Predictive value of individual biomarkers [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 264
Study Start Date: July 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01480869

Locations
France
CRLC Val d'Aurelle-Paul Lamarque Recruiting
Montpellier, France, 34298
Contact: William Jacot, MD     +33 4 67 61 31 49     william.jacot@montpellier.unicancer.fr    
Principal Investigator: William Jacot, MD            
Sponsors and Collaborators
Centre Val d'Aurelle - Paul Lamarque
  More Information

No publications provided

Responsible Party: Centre Val d'Aurelle - Paul Lamarque
ClinicalTrials.gov Identifier: NCT01480869     History of Changes
Other Study ID Numbers: VITACAL, VA 2010/12, 2010-023459-27
Study First Received: November 24, 2011
Last Updated: November 28, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Val d'Aurelle - Paul Lamarque:
Breast cancer
Vitamin D supplementation
in neoadjuvant
adjuvant setting

Additional relevant MeSH terms:
Calcium, Dietary
Breast Neoplasms
Vitamin D Deficiency
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
 Nutrition Disorders
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 16, 2013