Cargando…
CBD-oil as a potential solution in case of severe tamoxifen-related side effects
Tamoxifen may lead to bothersome side effects contributing to non-compliance and decreased quality of life. Patients searching for relief are increasingly turning to cannabinoids such as CBD-oil. However, CBD-oil might affect tamoxifen pharmacokinetics (PK) through CYP2D6 inhibition. The aims of thi...
Autores principales: | , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Nature Publishing Group UK
2023
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10404290/ https://www.ncbi.nlm.nih.gov/pubmed/37543688 http://dx.doi.org/10.1038/s41523-023-00570-x |
_version_ | 1785085266889801728 |
---|---|
author | Buijs, Sanne M. Braal, C. Louwrens Buck, Stefan A. J. van Maanen, Noud F. van der Meijden-Erkelens, Lonneke M. Kuijper-Tissot van Patot, Heleen A. Hoop, Esther Oomen-de Saes, Lotte van den Boogerd, Sophia J. Struik, Liesbeth E. M. van Rossum-Schornagel, Quirine C. Mathijssen, Ron H. J. Koolen, Stijn L. W. Jager, Agnes |
author_facet | Buijs, Sanne M. Braal, C. Louwrens Buck, Stefan A. J. van Maanen, Noud F. van der Meijden-Erkelens, Lonneke M. Kuijper-Tissot van Patot, Heleen A. Hoop, Esther Oomen-de Saes, Lotte van den Boogerd, Sophia J. Struik, Liesbeth E. M. van Rossum-Schornagel, Quirine C. Mathijssen, Ron H. J. Koolen, Stijn L. W. Jager, Agnes |
author_sort | Buijs, Sanne M. |
collection | PubMed |
description | Tamoxifen may lead to bothersome side effects contributing to non-compliance and decreased quality of life. Patients searching for relief are increasingly turning to cannabinoids such as CBD-oil. However, CBD-oil might affect tamoxifen pharmacokinetics (PK) through CYP2D6 inhibition. The aims of this open-label, single-arm study were (1) to determine the PK profile of tamoxifen when using CBD-oil, and (2) to subsequently investigate whether CBD-oil has a beneficial influence on side effects. Study patients had to have steady-state endoxifen concentrations ≥16 nM (conservative threshold). PK sampling and side effect assessment was done at initiation of CBD-oil and 28 days thereafter. Bio-equivalence could be concluded if the 90% confidence interval (CI) for the difference in endoxifen AUC fell within the [−20%; +25%] interval. The effect of CBD-oil on side effects was evaluated using the FACT-ES questionnaire. Endoxifen AUC decreased after CBD-oil by 12.6% (n = 15, 90% CI −18.7%, −6.1%) but remained within bio-equivalence boundaries. The endocrine sub-scale of the FACT-ES improved clinically relevant with 6.7 points (n = 26, p < 0.001) and health-related quality of life improved with 4.7 points after using CBD (95% CI + 1.8, +7.6). We conclude that CBD-oil, if of good quality and with a dosage below 50 mg, does not have to be discouraged in patients using it for tamoxifen-related side effects. Clinical trial registration: International Clinical Trial Registry Platform (NL8786; https://www.who.int/clinical-trials-registry-platform). |
format | Online Article Text |
id | pubmed-10404290 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Nature Publishing Group UK |
record_format | MEDLINE/PubMed |
spelling | pubmed-104042902023-08-07 CBD-oil as a potential solution in case of severe tamoxifen-related side effects Buijs, Sanne M. Braal, C. Louwrens Buck, Stefan A. J. van Maanen, Noud F. van der Meijden-Erkelens, Lonneke M. Kuijper-Tissot van Patot, Heleen A. Hoop, Esther Oomen-de Saes, Lotte van den Boogerd, Sophia J. Struik, Liesbeth E. M. van Rossum-Schornagel, Quirine C. Mathijssen, Ron H. J. Koolen, Stijn L. W. Jager, Agnes NPJ Breast Cancer Article Tamoxifen may lead to bothersome side effects contributing to non-compliance and decreased quality of life. Patients searching for relief are increasingly turning to cannabinoids such as CBD-oil. However, CBD-oil might affect tamoxifen pharmacokinetics (PK) through CYP2D6 inhibition. The aims of this open-label, single-arm study were (1) to determine the PK profile of tamoxifen when using CBD-oil, and (2) to subsequently investigate whether CBD-oil has a beneficial influence on side effects. Study patients had to have steady-state endoxifen concentrations ≥16 nM (conservative threshold). PK sampling and side effect assessment was done at initiation of CBD-oil and 28 days thereafter. Bio-equivalence could be concluded if the 90% confidence interval (CI) for the difference in endoxifen AUC fell within the [−20%; +25%] interval. The effect of CBD-oil on side effects was evaluated using the FACT-ES questionnaire. Endoxifen AUC decreased after CBD-oil by 12.6% (n = 15, 90% CI −18.7%, −6.1%) but remained within bio-equivalence boundaries. The endocrine sub-scale of the FACT-ES improved clinically relevant with 6.7 points (n = 26, p < 0.001) and health-related quality of life improved with 4.7 points after using CBD (95% CI + 1.8, +7.6). We conclude that CBD-oil, if of good quality and with a dosage below 50 mg, does not have to be discouraged in patients using it for tamoxifen-related side effects. Clinical trial registration: International Clinical Trial Registry Platform (NL8786; https://www.who.int/clinical-trials-registry-platform). Nature Publishing Group UK 2023-08-05 /pmc/articles/PMC10404290/ /pubmed/37543688 http://dx.doi.org/10.1038/s41523-023-00570-x Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . |
spellingShingle | Article Buijs, Sanne M. Braal, C. Louwrens Buck, Stefan A. J. van Maanen, Noud F. van der Meijden-Erkelens, Lonneke M. Kuijper-Tissot van Patot, Heleen A. Hoop, Esther Oomen-de Saes, Lotte van den Boogerd, Sophia J. Struik, Liesbeth E. M. van Rossum-Schornagel, Quirine C. Mathijssen, Ron H. J. Koolen, Stijn L. W. Jager, Agnes CBD-oil as a potential solution in case of severe tamoxifen-related side effects |
title | CBD-oil as a potential solution in case of severe tamoxifen-related side effects |
title_full | CBD-oil as a potential solution in case of severe tamoxifen-related side effects |
title_fullStr | CBD-oil as a potential solution in case of severe tamoxifen-related side effects |
title_full_unstemmed | CBD-oil as a potential solution in case of severe tamoxifen-related side effects |
title_short | CBD-oil as a potential solution in case of severe tamoxifen-related side effects |
title_sort | cbd-oil as a potential solution in case of severe tamoxifen-related side effects |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10404290/ https://www.ncbi.nlm.nih.gov/pubmed/37543688 http://dx.doi.org/10.1038/s41523-023-00570-x |
work_keys_str_mv | AT buijssannem cbdoilasapotentialsolutionincaseofseveretamoxifenrelatedsideeffects AT braalclouwrens cbdoilasapotentialsolutionincaseofseveretamoxifenrelatedsideeffects AT buckstefanaj cbdoilasapotentialsolutionincaseofseveretamoxifenrelatedsideeffects AT vanmaanennoudf cbdoilasapotentialsolutionincaseofseveretamoxifenrelatedsideeffects AT vandermeijdenerkelenslonnekem cbdoilasapotentialsolutionincaseofseveretamoxifenrelatedsideeffects AT kuijpertissotvanpatotheleena cbdoilasapotentialsolutionincaseofseveretamoxifenrelatedsideeffects AT hoopestheroomende cbdoilasapotentialsolutionincaseofseveretamoxifenrelatedsideeffects AT saeslotte cbdoilasapotentialsolutionincaseofseveretamoxifenrelatedsideeffects AT vandenboogerdsophiaj cbdoilasapotentialsolutionincaseofseveretamoxifenrelatedsideeffects AT struikliesbethem cbdoilasapotentialsolutionincaseofseveretamoxifenrelatedsideeffects AT vanrossumschornagelquirinec cbdoilasapotentialsolutionincaseofseveretamoxifenrelatedsideeffects AT mathijssenronhj cbdoilasapotentialsolutionincaseofseveretamoxifenrelatedsideeffects AT koolenstijnlw cbdoilasapotentialsolutionincaseofseveretamoxifenrelatedsideeffects AT jageragnes cbdoilasapotentialsolutionincaseofseveretamoxifenrelatedsideeffects |