CBD-oil as a potential solution in case of severe tamoxifen-related side effects

Sanne M. Buijs; C. Louwrens Braal; Stefan A.J. Buck; Noud F. van Maanen; Lonneke M. van der Meijden-Erkelens; Heleen A. Kuijper-Tissot van Patot; Esther Oomen de Hoop; Lotte Saes; Sophia J. van den Boogerd; Liesbeth E.M. Struik; Quirine C. van Rossum-Schornagel; Ron H.J. Mathijssen; Stijn L.W. Koolen; Agnes Jager

doi:10.1038/s41523-023-00570-x

CBD-oil as a potential solution in case of severe tamoxifen-related side effects

Sanne M. Buijs^*, C. Louwrens Braal, Stefan A.J. Buck, Noud F. van Maanen, Lonneke M. van der Meijden-Erkelens, Heleen A. Kuijper-Tissot van Patot, Esther Oomen de Hoop, Lotte Saes, Sophia J. van den Boogerd, Liesbeth E.M. Struik, Quirine C. van Rossum-Schornagel, Ron H.J. Mathijssen, Stijn L.W. Koolen, Agnes Jager

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

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Abstract

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).

Original language	English
Article number	63
Journal	npj Breast Cancer
Volume	9
Issue number	1
DOIs	https://doi.org/10.1038/s41523-023-00570-x
Publication status	Published - 5 Aug 2023

Bibliographical note

Funding Information:
This research was partly funded by Clinical Cannabis Care. Clinical Cannabis Care provided the CBD-oil and part of the study conduct costs. LvdME and HAKTvP from Clinical Cannabis Care were involved in conceiving the study design and revising and approving the final version of the manuscript. Clinical Cannabis Care was not in any way involved in the primary study idea, collection, analysis and interpretation of the data. This work was presented at the 45thSan Antonio Breast Cancer Symposium (#P1-02-08, San Antonio, TX, December 6–10, 2022).

Funding Information:
This research was partly funded by Clinical Cannabis Care. Clinical Cannabis Care provided the CBD-oil and part of the study conduct costs. LvdME and HAKTvP from Clinical Cannabis Care were involved in conceiving the study design and revising and approving the final version of the manuscript. Clinical Cannabis Care was not in any way involved in the primary study idea, collection, analysis and interpretation of the data. This work was presented at the 45 San Antonio Breast Cancer Symposium (#P1-02-08, San Antonio, TX, December 6–10, 2022). th

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© 2023, Springer Nature Limited.

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CBD-oil as a potential solution in case of severe tamoxifen-related side effectsFinal published version, 443 KBLicence: CC BY

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Buijs, S. M., Braal, C. L., Buck, S. A. J., van Maanen, N. F., van der Meijden-Erkelens, L. M., Kuijper-Tissot van Patot, H. A., Hoop, E. O. D., Saes, L., van den Boogerd, S. J., Struik, L. E. M., van Rossum-Schornagel, Q. C., Mathijssen, R. H. J., Koolen, S. L. W., & Jager, A. (2023). CBD-oil as a potential solution in case of severe tamoxifen-related side effects. npj Breast Cancer, 9(1), Article 63. https://doi.org/10.1038/s41523-023-00570-x

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title = "CBD-oil as a potential solution in case of severe tamoxifen-related side effects",

abstract = "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).",

author = "Buijs, {Sanne M.} and Braal, {C. Louwrens} and Buck, {Stefan A.J.} and {van Maanen}, {Noud F.} and {van der Meijden-Erkelens}, {Lonneke M.} and {Kuijper-Tissot van Patot}, {Heleen A.} and Hoop, {Esther Oomen de} and Lotte Saes and {van den Boogerd}, {Sophia J.} and Struik, {Liesbeth E.M.} and {van Rossum-Schornagel}, {Quirine C.} and Mathijssen, {Ron H.J.} and Koolen, {Stijn L.W.} and Agnes Jager",

note = "Funding Information: This research was partly funded by Clinical Cannabis Care. Clinical Cannabis Care provided the CBD-oil and part of the study conduct costs. LvdME and HAKTvP from Clinical Cannabis Care were involved in conceiving the study design and revising and approving the final version of the manuscript. Clinical Cannabis Care was not in any way involved in the primary study idea, collection, analysis and interpretation of the data. This work was presented at the 45thSan Antonio Breast Cancer Symposium (#P1-02-08, San Antonio, TX, December 6–10, 2022). Funding Information: This research was partly funded by Clinical Cannabis Care. Clinical Cannabis Care provided the CBD-oil and part of the study conduct costs. LvdME and HAKTvP from Clinical Cannabis Care were involved in conceiving the study design and revising and approving the final version of the manuscript. Clinical Cannabis Care was not in any way involved in the primary study idea, collection, analysis and interpretation of the data. This work was presented at the 45 San Antonio Breast Cancer Symposium (#P1-02-08, San Antonio, TX, December 6–10, 2022). th Publisher Copyright: {\textcopyright} 2023, Springer Nature Limited.",

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doi = "10.1038/s41523-023-00570-x",

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Buijs, SM, Braal, CL, Buck, SAJ, van Maanen, NF, van der Meijden-Erkelens, LM, Kuijper-Tissot van Patot, HA, Hoop, EOD, Saes, L, van den Boogerd, SJ, Struik, LEM, van Rossum-Schornagel, QC, Mathijssen, RHJ , Koolen, SLW & Jager, A 2023, 'CBD-oil as a potential solution in case of severe tamoxifen-related side effects', npj Breast Cancer, vol. 9, no. 1, 63. https://doi.org/10.1038/s41523-023-00570-x

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AU - Buck, Stefan A.J.

AU - van Maanen, Noud F.

AU - van der Meijden-Erkelens, Lonneke M.

AU - Kuijper-Tissot van Patot, Heleen A.

AU - Hoop, Esther Oomen de

AU - Saes, Lotte

AU - van den Boogerd, Sophia J.

AU - Struik, Liesbeth E.M.

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AU - Mathijssen, Ron H.J.

AU - Koolen, Stijn L.W.

AU - Jager, Agnes

N1 - Funding Information: This research was partly funded by Clinical Cannabis Care. Clinical Cannabis Care provided the CBD-oil and part of the study conduct costs. LvdME and HAKTvP from Clinical Cannabis Care were involved in conceiving the study design and revising and approving the final version of the manuscript. Clinical Cannabis Care was not in any way involved in the primary study idea, collection, analysis and interpretation of the data. This work was presented at the 45thSan Antonio Breast Cancer Symposium (#P1-02-08, San Antonio, TX, December 6–10, 2022). Funding Information: This research was partly funded by Clinical Cannabis Care. Clinical Cannabis Care provided the CBD-oil and part of the study conduct costs. LvdME and HAKTvP from Clinical Cannabis Care were involved in conceiving the study design and revising and approving the final version of the manuscript. Clinical Cannabis Care was not in any way involved in the primary study idea, collection, analysis and interpretation of the data. This work was presented at the 45 San Antonio Breast Cancer Symposium (#P1-02-08, San Antonio, TX, December 6–10, 2022). th Publisher Copyright: © 2023, Springer Nature Limited.

PY - 2023/8/5

Y1 - 2023/8/5

N2 - 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).

AB - 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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CBD-oil as a potential solution in case of severe tamoxifen-related side effects

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