Back to Search
Start Over
A Phase II Multicenter Trial on High-Dose Vitamin D Supplementation for the Correction of Vitamin D Insufficiency in Patients with Breast Cancer Receiving Adjuvant Chemotherapy
- Source :
- Nutrients, Nutrients; Volume 13; Issue 12; Pages: 4429, Nutrients, MDPI, 2021, 13 (12), pp.4429. ⟨10.3390/nu13124429⟩, Nutrients, Vol 13, Iss 4429, p 4429 (2021)
- Publication Year :
- 2021
-
Abstract
- International audience; Breast cancer (BC) treatments induce vitamin D (VD) insufficiency and bone metabolism changes, resulting in osteoporosis and skeletal morbidity risk. We report the results of a bicentric phase II trial (ClinicalTrials.gov Identifier: NCT04091178) on the safety and efficacy of high-dose oral VD supplementation for VD deficiency correction in 44 patients with early BC treated with adjuvant chemotherapies. Patients received one dose of 100,000 IU 25-OH VD every 3 weeks from day 1 of cycle 1 to day 1 of cycle 5. The primary endpoint was the percentage of patients achieving serum 25-OH VD concentration normalization on day 1 of cycle 6 (D1C6). Secondary endpoints were safety, VD and calcium parameters at baseline and during chemotherapy, and identification of predictive biomarkers of VD normalization on D1C6. On D1C6, 21 patients (47.7%, 95% CI: 33.0–62.8) achieved VD normalization. No VD-related clinical toxicity was reported. However, 13 patients (29.5%) presented asymptomatic grade 1 hypercalciuria, leading to interruption of the high-dose oral VD supplementation in 10, followed by a rapid reduction in serum VD concentration. No baseline clinical factor was predictive of VD normalization on D1C6. This high-dose VD supplementation appears safe and efficient in patients with early BC receiving adjuvant chemotherapy.
- Subjects :
- Adult
Nutrition and Dietetics
Nutrition. Foods and food supply
[SDV.CAN]Life Sciences [q-bio]/Cancer
Breast Neoplasms
Middle Aged
Vitamin D Deficiency
Article
adjuvant chemotherapy
Treatment Outcome
breast cancer
Chemotherapy, Adjuvant
Dietary Supplements
Humans
TX341-641
Female
Vitamin D
vitamin D insufficiency
Biomarkers
Food Science
hypercalciuria
Aged
Subjects
Details
- ISSN :
- 20726643
- Volume :
- 13
- Issue :
- 12
- Database :
- OpenAIRE
- Journal :
- Nutrients
- Accession number :
- edsair.doi.dedup.....a61b27b7f5e3d959372bbcb7d5dbf540
- Full Text :
- https://doi.org/10.3390/nu13124429⟩