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: The aim was to recruit 45 patients via an NHS oncology centre with a diagnosis of early or locally advanced breast cancer. Participants were allocated to Iscador®Malus, Iscador®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.
背景/目的：在英国国家医疗服务体系(NHS)背景下，测试一项包含定性研究的混合阶段、试点性、安慰剂对照、双盲槲寄生疗法(MT)试验的可行性。方法：计划通过NHS肿瘤中心招募45名确诊为早期或局部晚期乳腺癌的患者。参与者被分配接受Iscador®Malus、Iscador®Pinus或生理盐水（安慰剂）治疗。研究过程中使用日记和生活质量问卷进行评估，并对参与者、肿瘤科医生及护士进行定性访谈。可行性通过招募率、保留率、依从性、盲法实施及安全性进行评估。结果：2019年8月至2020年3月期间共接触67名患者，15人同意参与，14名参与者完成随机分组，其中2人在试验期间退出。研究共访谈10名参与者和5名医护人员。招募障碍主要包括额外治疗/时间成本、附加注射程序及可能被分配至安慰剂组。参与者在接受研究治疗期间表现出良好的依从性。日记和访谈数据显示14名参与者中有11人存在注射困难或皮肤反应。共记录22例与槲寄生疗法相关的不良事件，均涉及注射反应或皮肤症状。结论：本试点研究探讨了在英国NHS体系内开展槲寄生疗法治疗乳腺癌患者的随机安慰剂对照双盲试验的可行性。研究结果系统阐述了该背景下在招募、保留、依从性、盲法实施及安全性方面面临的挑战与取得的成果。
肿瘤(癌症)患者之家