A pilot study of the Mistletoe and Breast Cancer (MAB) trial: a protocol for a randomised double-blind controlled trial

Susan B Bryant, Lorna Duncan, Gene S Feder, Alyson L Huntley*

*Corresponding author for this work

Research output: Contribution to journalReview article (Academic Journal)peer-review

3 Citations (Scopus)
64 Downloads (Pure)

Abstract

Background:
A Cochrane review of mistletoe therapy concludes that there is some evidence that mistletoe extracts may offer benefits on measures of quality of life during chemotherapy for breast cancer, but these results need replication. Our aim was to test the feasibility of within a pilot placebo controlled, double blind randomised controlled trial of mistletoe therapy in patients with breast cancer undergoing chemotherapy with or without radiotherapy.

Methods/design:
A mixed phase pilot placebo controlled, double blind randomised controlled trial of mistletoe therapy in patients with breast cancer. EudraCT number: 2018-000279-34 There will be three arms (groups) in the trial: Iscador M, Iscador P, with physiological saline as the placebo. The aim is to recruit 45 adult patients with a new diagnosis of early or locally advanced breast cancer, up to 12 weeks following definitive breast surgery whose standard treatment plan includes chemotherapy with or without radiotherapy. They will be taught to administer the Mistletoe And Breast cancer (MAB) therapies subcutaneously and will titrate up to their optimal dose. MAB therapy will continue throughout their standard chemotherapy and radiotherapy and one month beyond. The main outcome of the MAB study is the feasibility of conducting such a trial within the NHS in order to inform a future fully powered investigative trial. Feasibility will be measured through recruitment, retention and patient experience using clinical research forms, patient diaries, cancer-related questionnaires and qualitative interviews conducted with both patients and oncology staff.

Discussion:
This trial is the first of its kind in the UK. Currently mistletoe therapy is mostly available through private practice in the UK. Completion of this feasibility study will support applications for further funding for a fully powered randomised controlled trial which will measure effectiveness and cost-effectiveness of this herbal therapy.
Original languageEnglish
Article number78
Pages (from-to)1-8
JournalPilot and Feasibility Studies
Volume8
Issue number1
DOIs
Publication statusPublished - 6 Apr 2022

Bibliographical note

Funding Information:
The MAB study has received financial support from Verein für Krebsforschung (Society for Cancer Research), Arlesheim, Switzerland, for running costs and staff salaries (LD); Camphill Wellbeing Trust, for developmental work, running costs and staff salaries (AH, LD, SB); Claire Hunter Trust, for patient costs; Bristol University cancer fund, for staff salaries; (SB) School of Primary Care Research Grant (SPCR), for developmental work, running costs and staff salaries (AH, ME, SB); flexibility and sustainability funding from Avon Primary Care Research Collaborative, for developmental work and grant writing time for AH; and Iscador AG, Iscador and placebo product.

Funding Information:
We would like to thank the MAB steering group for their help in the development of the MAB project, Jeremy Braybrooke (consultant oncologist), Maggie Evans (researcher), Esther van der Werf (researcher), Sharon Love (statistician) and Elizabeth Thompson (clinician); the MAB advisory group who has provided extra expertise, Jo Beedell (patient representative, Sue Bell (patient representative), Stephen Falk (consultant oncologist), Matthias Kröz (mistletoe expert) and Maurice Orange (mistletoe expert); the Bristol Haematology and Oncology Centre staff for clinical expertise and useful comments on the protocol; and the MAB trial steering, data monitoring and ethics committee for their independent oversight, Willie Hamilton (professor of cancer diagnosis in primary care and chair), Sarah Pirrie (independent statistician), Jo Beedell (patient representative) and Sue Bell (patient representative).

Publisher Copyright:
© 2022, The Author(s).

Keywords

  • Mistletoe therapy
  • Herbal
  • Breast Cancer
  • RCT
  • Quality of Life
  • Fatigue

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