| Added by | standudu |
|---|---|
| Group name | EquipeCTCS |
| Item Type | Journal Article |
| Title | 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 |
| Creator | Chartron et al. |
| Author | Elodie Chartron |
| Author | Nelly Firmin |
| Author | Célia Touraine |
| Author | Angélique Chapelle |
| Author | Eric Legouffe |
| Author | Lobna Rifai |
| Author | Lise Roca |
| Author | Véronique D'Hondt |
| Author | William Jacot |
| Abstract | 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. |
| Publication | Nutrients |
| Volume | 13 |
| Issue | 12 |
| Pages | 4429 |
| Date | 2021-12-10 |
| Journal Abbr | Nutrients |
| Language | eng |
| DOI | 10.3390/nu13124429 |
| ISSN | 2072-6643 |
| Library Catalog | PubMed |
| Extra | PMID: 34959982 PMCID: PMC8706061 |
| Tags | Adult, Aged, Biomarkers, breast cancer, Breast Neoplasms, Chemotherapy, Adjuvant, clinic, corresponding, Dietary Supplements, Female, Humans, last, marque, Middle Aged, Treatment Outcome, Vitamin D, Vitamin D Deficiency, vitamin D insufficiency |
| Date Added | 2022/07/29 - 11:56:58 |
| Date Modified | 2023/11/14 - 14:54:37 |
| Notes and Attachments | PubMed entry (Attachment) Texte intégral (Attachment) |
Institut de Recherche en Cancérologie de
