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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 ).

SUBMITTER: Buijs SM

PROVIDER: S-EPMC10404290 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature

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

Buijs Sanne M SM Braal C Louwrens CL Buck Stefan A J SAJ van Maanen Noud F NF van der Meijden-Erkelens Lonneke M LM Kuijper-Tissot van Patot Heleen A HA Hoop Esther Oomen-de EO Saes Lotte L van den Boogerd Sophia J SJ Struik Liesbeth E M LEM van Rossum-Schornagel Quirine C QC Mathijssen Ron H J RHJ Koolen Stijn L W SLW Jager Agnes A

NPJ breast cancer 20230805 1

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. Stu ...[more]

PMID: 37543688

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Project description:Cannabidiol (CBD)-containing products are widely marketed as over the counter products, mostly as food supplements, to avoid the strict rules of medicinal products. Side-effects reported in anecdotal consumer reports or during clinical studies were first assumed to be due to hydrolytic conversion of CBD to psychotropic ? 9-tetrahydrocannabinol (? 9-THC) in the stomach after oral consumption. However, research of pure CBD solutions stored in simulated gastric juice or subjected to various storage conditions such as heat and light with specific liquid chromatographic/tandem mass spectrometric (LC/MS/MS) and ultra-high pressure liquid chromatographic/quadrupole time-of-flight mass spectrometric (UPLC-QTOF) analyses was unable to confirm THC formation. Another hypothesis for the side-effects of CBD products may be residual ? 9-THC concentrations in the products as contamination, because most of them are based on crude hemp extracts containing the full spectrum of cannabinoids besides CBD. Analyses of 67 food products of the German market (mostly CBD oils) confirmed this hypothesis: 17 products (25%) contained ? 9-THC above the lowest observed adverse effects level (2.5 mg/day). Inversely, CBD was present in the products below the no observed adverse effect level. Hence, it may be assumed that the adverse effects of some commercial CBD products are based on a low-dose effect of ? 9-THC and not due to effects of CBD itself. The safety, efficacy and purity of commercial CBD products is highly questionable, and all of the products in our sample collection showed various non-conformities to European food law such as unsafe ? 9-THC levels, full-spectrum hemp extracts as non-approved novel food ingredients, non-approved health claims, and deficits in mandatory food labelling requirements. In view of the growing market for such lifestyle products, the effectiveness of the instrument of food business operators' own responsibility for product safety must obviously be challenged.

Project description:PurposeTo determine the associations between ethnicity, age at diagnosis, obesity, multimorbidity, and odds of experiencing breast cancer (BC) treatment-related side effects among long-term Hispanic and non-Hispanic white (NHW) survivors from New Mexico and explore differences by tamoxifen use.MethodsLifestyle and clinical information including self-reported tamoxifen use and presence of treatment- related side effects were collected at follow-up interviews (12-15 years) for 194 BC survivors. Multivariable logistic regression models were used to examine associations between predictors and odds of experiencing side effects overall and by tamoxifen use.ResultsWomen ranged in age at diagnosis (30-74, M = 49.3, SD = 9.37), most were NHW (65.4%) and had in-situ or localized BC (63.4%). Less than half reportedly used tamoxifen (44.3%), of which 59.3% reported using > 5 years. Overall, survivors who were overweight/obese at follow-up were 5.42 times more likely to experience treatment-related pain (95% CI 1.40-21.0) compared to normal weight survivors. Survivors with multimorbidity, compared to survivors without, were more likely to report treatment-related sexual health issues (aOR 6.90, 95% CI 1.43-33.2) and poorer mental health (aOR 4.51, 95% CI 1.06-19.1). The statistical interactions between ethnicity and overweight/obese with tamoxifen use were significant (p-interaction < 0.05) for treatment-related sexual health issues.ConclusionOur results demonstrate that survivors with overweightness/obesity or multimorbidity may be more likely to experience BC treatment-related side effects. Tamoxifen use modifies associations between ethnicity, being overweight/obese, and sexual health issues following treatment. The likelihood of experiencing treatment-related side effects were more favorable for those on tamoxifen or those who had used tamoxifen for longer durations. These findings highlight the importance of fostering side effect awareness and applying appropriate interventions to assist with disease management throughout BC survivorship care.

Dataset Information

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

Publications

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

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