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

Area of Science:

• Oncology
• Complementary Medicine
• Clinical Trials

Background:

• Mistletoe therapy (MT) is a complementary treatment used in some breast cancer care.
• Its feasibility in a UK National Health Service (NHS) setting requires investigation.
• A pilot, placebo-controlled, double-blind trial with a qualitative component was designed.

Purpose of the Study:

• To assess the feasibility of a randomized controlled trial (RCT) for mistletoe therapy in breast cancer patients.
• To evaluate recruitment, retention, adherence, blinding, and safety within the NHS.
• To gather qualitative insights from patients and healthcare professionals.

Main Methods:

• A pilot, mixed-phase, placebo-controlled, double-blind trial was conducted.
• 45 breast cancer patients were targeted for recruitment in an NHS oncology center.
• Participants received Iscador® Malus, Iscador® Pinus, or placebo, with feasibility assessed through diaries, questionnaires, and interviews.

Main Results:

• 14 participants were randomized, with 2 withdrawals.
• Recruitment challenges included time commitment, extra injections, and placebo uncertainty.
• 11/14 participants experienced injection/skin reactions; 22 adverse events were reported, primarily injection-related.

Conclusions:

• Conducting a randomized placebo-controlled trial of mistletoe therapy for breast cancer in the UK NHS is feasible.
• Challenges in recruitment and patient-reported side effects (injections, skin reactions) were identified.
• Further research should address these feasibility aspects for future large-scale trials.