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The Mistletoe and Breast Cancer (MAB) Study: A UK Mixed-Phase, Pilot, Placebo-Controlled, Double-Blind, Randomised Controlled Trial

Year: 2025

Type: article

Study designs: Randomized Controlled Trial, Clinical Trial

Abstract: BACKGROUND/OBJECTIVE: To test the feasibility of a mixed-phase, pilot, placebo-controlled, double-blind trial of mistletoe therapy (MT) with an embedded qualitative study in the UK National Health Service (NHS) setting. METHODS: Pinus, or physiological saline (placebo). Diaries and quality-of-life questionnaires were administered. Qualitative interviews were conducted with participants, oncologists, and nurses. Feasibility was assessed by recruitment, retention, adherence, blinding, and safety. RESULTS: Sixty-seven patients were approached between August 2019 and March 2020, 15 gave consent, 14 participants were randomised, and 2 withdrew during the trial. Ten participants and five staff were interviewed. Barriers to recruitment were the additional treatments/time, extra injections, and the possibility of placebo allocation. Adherence was very good whilst the participants were on the study therapy. Diaries and interviews indicated that 11/14 participants struggled with injections and skin reactions. There were 22 adverse events due to the MT, related to the injections or skin reactions. CONCLUSION: This pilot study examined the feasibility of conducting a randomised placebo-controlled, double-blind trial of mistletoe therapy for breast cancer patients within the UK NHS. The results describe the challenges and achievements of recruitment, retention, adherence, blinding, and safety in this context.

Source: Cancers

DOI: 10.3390/cancers17193169