Clinical trial NCT01480869: Study of Vitamin D Supplementation Tailored to Vitamin D Deficiency in Breast Cancer Patients
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Breast cancer
Vitamin D supplementation
in neoadjuvant
adjuvant setting
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2011-11-29
Enrollment: 215
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: To evaluate the increase in normalization of serum vitamin D level
timeFrame: 6 months
Secondary outcomes:
measure: Baseline vitamin D/calcium status in this patient population
timeFrame: Baseline
measure: Normalization rate of serum 25-OHD level
timeFrame: 12, 18 and 24 months
measure: Normalization rate of serum 25-OHD level in control patients who shift to experimental strategy
timeFrame: 6 months after crossover
measure: Clinical and biological tolerance profile
timeFrame: During treament administration (can last up to 24 months)
measure: Treatment compliance
timeFrame: During treatment administration (can last up to 24 months)
measure: Quality of life
timeFrame: 24 months
measure: Impact of study treatments on bone and joint pains induced by aromatase inhibitors
timeFrame: During treatment administration (can last up to 24 months)
measure: Changes in vitamin and calcium biological markers
timeFrame: Up to 24 months
measure: Predictive value of individual biomarkers
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CRLC Val d'Aurelle-Paul Lamarque
Study officials:
References:
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.