Trial reportBritish journal of cancer2023
Side effects of low-dose tamoxifen: results from a six-armed randomised controlled trial in healthy women.
Trial report in British journal of cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03346200 (A Randomised, Double Blinded, Six-armed Placebo Controlled Study to Investigate Optimal Dose of Tamoxifen With the Most Favourable Side Effect Spectre and With Mammography Density Reduction Non-inferior to That of 20 mg Tamoxifen), which is not on this map. Cited by 26 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomised, Double Blinded, Six-armed Placebo Controlled Study to Investigate Optimal Dose of Tamoxifen With the Most Favourable Side Effect Spectre and With Mammography Density Reduction Non-inferior to That of 20 mg Tamoxifen
Who cites it
26 citing papers in PubMed, 28 citations in OpenAlex.
- Endoxifen for mammographic density reduction-results from the KARISMA endoxifen trial.Journal of the National Cancer Institute · 2026Trial
- Influence of endoxifen on mammographic density: results from the KARISMA-Tam trial.Journal of the National Cancer Institute · 2025Trial
- Low-dose tamoxifen treatment reduces collagen organisation indicative of tissue stiffness in the normal breast: results from the KARISMA randomised controlled trial.Breast cancer research : BCR · 2024Trial
- Low-dose tamoxifen ameliorates ovariectomy-induced metabolic and immune dysfunction.GeroScience · 2026Article
- Perceptions of Chemoprevention Among Women at High Risk for Breast Cancer.JAMA network open · 2026Article
- Women's preferences for breast cancer risk-reducing medications: a discrete choice experiment study.NPJ breast cancer · 2026Article
- Adherence to Endocrine Prevention in Patients with Atypical Hyperplasia and Lobular Carcinoma In Situ: Promising Trends from Real-World Use of Low-Dose Tamoxifen.Annals of surgical oncology · 2026Article
- A pilot study of a behavior-change intervention for preventive therapy among women at high risk for invasive breast cancer.BMC medical informatics and decision making · 2026Article
- The Combined Effects of Eleutherine bulbosa Ethanol Extract and Tamoxifen On Cox-2 Levels in a BaLB/c Mouse Breast Cancer Model.Asian Pacific journal of cancer prevention : APJCP · 2026Article
- Article
- Multicomplex Pharmacophore Modeling of Estrogen Receptors Suggests the Probable Repurposing of Procaterol as an Antiproliferative Agent Against Breast Cancer Cells.International journal of molecular sciences · 2026Article
- Oxidative DNA damage induced by 3,4-diOH-TAM, a tamoxifen metabolite, in relation to endometrial carcinogenesis.Scientific reports · 2025Article
- Andrographolide Selectively Inhibits the Growth of LA7 Mammary Adenocarcinoma Cells.ACS omega · 2025Article
- Pharmacological Prevention in Breast Cancer: Current Evidence, Challenges, and Future Directions.Cancers · 2025Review
- Psychometric Evaluation of the Chinese Version of the Vulvovaginal Symptom Questionnaire in Women With Breast Cancer.Journal of advanced nursing · 2025Article
- Evaluation of a digital reporting and supporting tool in breast cancer prevention trials (KarmApp).BMC health services research · 2025Article
- Article
- Women's preferences for testing to predict breast cancer risk - a discrete choice experiment.Journal of translational medicine · 2025Article
- Review
- A Scoping Review of Primary Breast Cancer Risk Reduction Strategies in East and Southeast Asia.Cancers · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAdherence to adjuvant tamoxifen therapy is suboptimal, and acceptance of tamoxifen for primary prevention is poor. Published results indicate effect of low-dose tamoxifen therapy. Using questionnaire data from a randomised controlled trial, we describe side effects of standard and low-dose tamoxifen in healthy women.
methodsIn the KARISMA trial, 1440 healthy women were randomised to 6 months of daily intake of 20, 10, 5, 2.5, 1 mg of tamoxifen or placebo. Participants completed a 48-item, five-graded Likert score symptom questionnaire at baseline and follow-up. Linear regression models were used to identify significant changes in severity levels across doses and by menopausal status.
resultsOut of 48 predefined symptoms, five were associated with tamoxifen exposure (hot flashes, night sweats, cold sweats, vaginal discharge and muscle cramps). When comparing these side effects in premenopausal women randomised to low doses (2.5, 5 mg) versus high doses (10, 20 mg), the mean change was 34% lower in the low-dose group. No dose-dependent difference was seen in postmenopausal women.
conclusionsSymptoms related to tamoxifen therapy are influenced by menopausal status. Low-dose tamoxifen, in contrast to high-dose, was associated with less pronounced side effects, a finding restricted to premenopausal women. Our findings give new insights which may influence future dosing strategies of tamoxifen in both the adjuvant and preventive settings.
trial registrationClinicalTrials.gov ID: NCT03346200.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.