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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.


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the increase in normalization of serum vitamin D level

Outcome 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.

Outcome Time Frame:

6 months

Safety Issue:

No

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

VITACAL

NCT ID:

NCT01480869

Start Date:

July 2011

Completion Date:

July 2015

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • Vitamin D supplementation
  • in neoadjuvant
  • adjuvant setting
  • Breast Neoplasms
  • Vitamin D Deficiency

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