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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...

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Autores principales: 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
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
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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).
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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
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