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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01480869
• Date of registration: 24/11/2011
• Prospective Registration: No
• Primary sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
• Public title: Study of Vitamin D Supplementation Tailored to Vitamin D Deficiency in Breast Cancer Patients VITACAL
• Scientific 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.
• Date of first enrolment: July 2011
• Target sample size: 215
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01480869
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

France

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Drug: calcium and cholecalciferol

Primary Outcome(s)

To evaluate the increase in normalization of serum vitamin D level [Time Frame: 6 months]

Secondary Outcome(s)

Baseline vitamin D/calcium status in this patient population [Time Frame: Baseline]

Changes in vitamin and calcium biological markers [Time Frame: Up to 24 months]

Normalization rate of serum 25-OHD level [Time Frame: 12, 18 and 24 months]

Clinical and biological tolerance profile [Time Frame: During treament administration (can last up to 24 months)]

Impact of study treatments on bone and joint pains induced by aromatase inhibitors [Time Frame: During treatment administration (can last up to 24 months)]

Treatment compliance [Time Frame: During treatment administration (can last up to 24 months)]

Predictive value of individual biomarkers [Time Frame: Up to 24 months]

Normalization rate of serum 25-OHD level in control patients who shift to experimental strategy [Time Frame: 6 months after crossover]

Quality of life [Time Frame: 24 months]

Secondary ID(s)

2010-023459-27

VA 2010/12

VITACAL

Source(s) of Monetary Support

Please refer to primary and secondary sponsors