Cargando…

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

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 suppl...

Descripción completa

Detalles Bibliográficos
Autores principales: Chartron, Elodie, Firmin, Nelly, Touraine, Célia, Chapelle, Angélique, Legouffe, Eric, Rifai, Lobna, Pouderoux, Stéphane, Roca, Lise, D’Hondt, Véronique, Jacot, William
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8706061/
https://www.ncbi.nlm.nih.gov/pubmed/34959982
http://dx.doi.org/10.3390/nu13124429
_version_ 1784622100719337472
author Chartron, Elodie
Firmin, Nelly
Touraine, Célia
Chapelle, Angélique
Legouffe, Eric
Rifai, Lobna
Pouderoux, Stéphane
Roca, Lise
D’Hondt, Véronique
Jacot, William
author_facet Chartron, Elodie
Firmin, Nelly
Touraine, Célia
Chapelle, Angélique
Legouffe, Eric
Rifai, Lobna
Pouderoux, Stéphane
Roca, Lise
D’Hondt, Véronique
Jacot, William
author_sort Chartron, Elodie
collection PubMed
description 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.
format Online
Article
Text
id pubmed-8706061
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher MDPI
record_format MEDLINE/PubMed
spelling pubmed-87060612021-12-25 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 Chartron, Elodie Firmin, Nelly Touraine, Célia Chapelle, Angélique Legouffe, Eric Rifai, Lobna Pouderoux, Stéphane Roca, Lise D’Hondt, Véronique Jacot, William Nutrients Article 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. MDPI 2021-12-10 /pmc/articles/PMC8706061/ /pubmed/34959982 http://dx.doi.org/10.3390/nu13124429 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Chartron, Elodie
Firmin, Nelly
Touraine, Célia
Chapelle, Angélique
Legouffe, Eric
Rifai, Lobna
Pouderoux, Stéphane
Roca, Lise
D’Hondt, Véronique
Jacot, William
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
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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8706061/
https://www.ncbi.nlm.nih.gov/pubmed/34959982
http://dx.doi.org/10.3390/nu13124429
work_keys_str_mv AT chartronelodie aphaseiimulticentertrialonhighdosevitamindsupplementationforthecorrectionofvitamindinsufficiencyinpatientswithbreastcancerreceivingadjuvantchemotherapy
AT firminnelly aphaseiimulticentertrialonhighdosevitamindsupplementationforthecorrectionofvitamindinsufficiencyinpatientswithbreastcancerreceivingadjuvantchemotherapy
AT tourainecelia aphaseiimulticentertrialonhighdosevitamindsupplementationforthecorrectionofvitamindinsufficiencyinpatientswithbreastcancerreceivingadjuvantchemotherapy
AT chapelleangelique aphaseiimulticentertrialonhighdosevitamindsupplementationforthecorrectionofvitamindinsufficiencyinpatientswithbreastcancerreceivingadjuvantchemotherapy
AT legouffeeric aphaseiimulticentertrialonhighdosevitamindsupplementationforthecorrectionofvitamindinsufficiencyinpatientswithbreastcancerreceivingadjuvantchemotherapy
AT rifailobna aphaseiimulticentertrialonhighdosevitamindsupplementationforthecorrectionofvitamindinsufficiencyinpatientswithbreastcancerreceivingadjuvantchemotherapy
AT pouderouxstephane aphaseiimulticentertrialonhighdosevitamindsupplementationforthecorrectionofvitamindinsufficiencyinpatientswithbreastcancerreceivingadjuvantchemotherapy
AT rocalise aphaseiimulticentertrialonhighdosevitamindsupplementationforthecorrectionofvitamindinsufficiencyinpatientswithbreastcancerreceivingadjuvantchemotherapy
AT dhondtveronique aphaseiimulticentertrialonhighdosevitamindsupplementationforthecorrectionofvitamindinsufficiencyinpatientswithbreastcancerreceivingadjuvantchemotherapy
AT jacotwilliam aphaseiimulticentertrialonhighdosevitamindsupplementationforthecorrectionofvitamindinsufficiencyinpatientswithbreastcancerreceivingadjuvantchemotherapy
AT chartronelodie phaseiimulticentertrialonhighdosevitamindsupplementationforthecorrectionofvitamindinsufficiencyinpatientswithbreastcancerreceivingadjuvantchemotherapy
AT firminnelly phaseiimulticentertrialonhighdosevitamindsupplementationforthecorrectionofvitamindinsufficiencyinpatientswithbreastcancerreceivingadjuvantchemotherapy
AT tourainecelia phaseiimulticentertrialonhighdosevitamindsupplementationforthecorrectionofvitamindinsufficiencyinpatientswithbreastcancerreceivingadjuvantchemotherapy
AT chapelleangelique phaseiimulticentertrialonhighdosevitamindsupplementationforthecorrectionofvitamindinsufficiencyinpatientswithbreastcancerreceivingadjuvantchemotherapy
AT legouffeeric phaseiimulticentertrialonhighdosevitamindsupplementationforthecorrectionofvitamindinsufficiencyinpatientswithbreastcancerreceivingadjuvantchemotherapy
AT rifailobna phaseiimulticentertrialonhighdosevitamindsupplementationforthecorrectionofvitamindinsufficiencyinpatientswithbreastcancerreceivingadjuvantchemotherapy
AT pouderouxstephane phaseiimulticentertrialonhighdosevitamindsupplementationforthecorrectionofvitamindinsufficiencyinpatientswithbreastcancerreceivingadjuvantchemotherapy
AT rocalise phaseiimulticentertrialonhighdosevitamindsupplementationforthecorrectionofvitamindinsufficiencyinpatientswithbreastcancerreceivingadjuvantchemotherapy
AT dhondtveronique phaseiimulticentertrialonhighdosevitamindsupplementationforthecorrectionofvitamindinsufficiencyinpatientswithbreastcancerreceivingadjuvantchemotherapy
AT jacotwilliam phaseiimulticentertrialonhighdosevitamindsupplementationforthecorrectionofvitamindinsufficiencyinpatientswithbreastcancerreceivingadjuvantchemotherapy