Mistletoe And Breast Cancer (MAB)
Research type
Research Study
Full title
Mistletoe And Breast Cancer (MAB): A pilot study for a randomized double-blind controlled trial
IRAS ID
239151
Contact name
Gene Feder
Contact email
Sponsor organisation
University of Bristol
Eudract number
2018-000279-34
Duration of Study in the UK
1 years, 1 months, 30 days
Research summary
Summary of Research
Previous research has suggested that mistletoe therapy can improve quality of life of women with breast cancer, decrease fatigue and diminish the side effects of chemotherapy and radiotherapy. However, the evidence is not strong enough to make mistletoe part of routine therapy for breast cancer, not least because there are few comparisons between mistletoe and an identical looking non-active treatment (placebo). In this pilot study we will test whether a randomised controlled trial of mistletoe injections compared to placebo injections during chemotherapy with or without radiotherapy is feasible. We will find out whether women are willing to take part in such a trial, whether the mistletoe treatment or placebo is acceptable to them and whether they complete the questionnaires we are using to measure outcomes. At the end of the study we will ask participants whether they knew which treatment they were getting (mistletoe or placebo). The results of this pilot study will help us plan a large trial to test whether mistletoe does improve quality of life and reduce symptoms of women during breast cancer treatment.Summary of Results
The feasibility MAB study recruited from August 2019- March 2020, successfully consenting 15 female participants and randomizing 14 of them. The average age was 50 years. During the progress of the trial two participants withdrew early due to 1) lack of feeling benefit from study therapy, and general stress and anxiety with her cancer treatment and the COVID-19 situation respectively. There were no serious adverse events reported, and 22 adverse events specific to mistletoe therapy of which all were related to short term, transitory skin reactions as a result of the subcutaneous injections of MAB therapy. Adherence to self -injection was excellent recorded by weekly diaries; as was completion of quality of life questionnaires at baseline, mid-study and at the end of study. An embedded qualitative study gave us a greater insight to both participant and health professional experiences of mistletoe therapy within the NHS setting.REC name
South West - Central Bristol Research Ethics Committee
REC reference
18/SW/0045
Date of REC Opinion
17 Apr 2018
REC opinion
Further Information Favourable Opinion