scholarly journals A Feasibility Study of the Mistletoe and Breast Cancer (MAB) Trial: A Protocol for a Randomised Double-blind Controlled Trial

2020 ◽  
Author(s):  
Susan Bryant ◽  
Lorna Duncan ◽  
Gene Feder ◽  
Alyson Huntley
Keyword(s):  
Breast Cancer ◽  
Randomised Controlled Trial ◽  
Feasibility Study ◽  
Controlled Trial ◽  
Locally Advanced ◽  
Cochrane Review ◽  
Double Blind ◽  
Randomised Controlled ◽  
The Uk ◽  
Mistletoe Therapy

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 a placebo controlled, double blind randomised controlled trial of mistletoe therapy in patients with breast cancer undergoing chemotherapy with or without radiotherapy. Methods/design: A placebo controlled, double blind randomised controlled trial of mistletoe therapy in patients with breast cancer. 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 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.

scholarly journals Comparing docosahexaenoic acid (DHA) concomitant with neoadjuvant chemotherapy versus neoadjuvant chemotherapy alone in the treatment of breast cancer (DHA WIN): protocol of a double-blind, phase II, randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e030502 ◽  
Author(s):  
Marnie Newell ◽  
John R Mackey ◽  
Gilbert Bigras ◽  
Mirey Alvarez-Camacho ◽  
Susan Goruk ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Randomised Controlled Trial ◽  
Neoadjuvant Chemotherapy ◽  
Docosahexaenoic Acid ◽  
Phase Ii ◽  
Controlled Trial ◽  
Dropout Rate ◽  
Phospholipid Content ◽  
Double Blind ◽  
Randomised Controlled

IntroductionNeoadjuvant chemotherapy for breast cancer treatment is prescribed to facilitate surgery and provide confirmation of drug-sensitive disease, and the achievement of pathological complete response (pCR) predicts improved long-term outcomes. Docosahexaenoic acid (DHA) has been shown to reduce tumour growth in preclinical models when combined with chemotherapy and is known to beneficially modulate systemic immune function. The purpose of this trial is to investigate the benefit of DHA supplementation in combination with neoadjuvant chemotherapy in patients with breast cancer.Methods and analysisThis is a double-blind, phase II, randomised controlled trial of 52 women prescribed neoadjuvant chemotherapy to test if DHA supplementation enhances chemotherapy efficacy. The DHA supplementation group will take 4.4 g/day DHA orally, and the placebo group will take an equal fat supplement of vegetable oil. The primary outcome will be change in Ki67 labelling index from prechemotherapy core needle biopsy to definitive surgical specimen. The secondary endpoints include assessment of (1) DHA plasma phospholipid content; (2) systemic immune cell types, plasma cytokines and inflammatory markers; (3) tumour markers for apoptosis and tumour infiltrating lymphocytes; (4) rate of pCR in breast and in axillary nodes; (5) frequency of grade 3 and 4 chemotherapy-associated toxicities; and (6) patient-perceived quality of life. The trial has 81% power to detect a significant between-group difference in Ki67 index with a two-sided t-test of less than 0.0497, and accounts for 10% dropout rate.Ethics and disseminationThis study has full approval from the Health Research Ethics Board of Alberta - Cancer Committee (Protocol #: HREBA.CC-18-0381). We expect to present the findings of this study to the scientific community in peer-reviewed journals and at conferences. The results of this study will provide evidence for supplementing with DHA during neoadjuvant chemotherapy treatment for breast cancer.Trial registration numberNCT03831178

scholarly journals Protocol for the ORaClES study: an online randomised controlled trial to improve clinical estimates of survival using a training resource for medical students

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e025265 ◽  
Author(s):  
Linda Oostendorp ◽  
Nicola White ◽  
Priscilla Harries ◽  
Sarah Yardley ◽  
Christopher Tomlinson ◽  
...  
Keyword(s):  
Palliative Care ◽  
Medical Students ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Online Training ◽  
Double Blind ◽  
Patient Will ◽  
Randomised Controlled ◽  
The Uk ◽  
Symptoms And Signs

IntroductionClinicians often struggle to recognise when palliative care patients are imminently dying (last 72 hours of life). A previous study identified the factors that expert palliative care doctors (with demonstrated prognostic skills) had used, to form a judgement about which patients were imminently dying. This protocol describes a study to evaluate whether an online training resource showing how experts weighted the importance of various symptoms and signs can teach medical students to formulate survival estimates for palliative care patients that are more similar to the experts’ estimates.Methods and analysisThis online double-blind randomised controlled trial will recruit at least 128 students in the penultimate or final year of medical school in the UK. Participants are asked to review three series of vignettes describing patients referred to palliative care and provide an estimate about the probability (0%–100%) that each patient will die within 72 hours. After the first series, students randomised to the intervention arm are given access to an online training resource. All participants are asked to complete a second series of vignettes. After 2 weeks, all participants are asked to complete a third series. The primary outcome will be the probability of death estimates (0%–100%) provided by students in the intervention and control arms for the second series of vignettes. Secondary outcomes include the maintenance effect at 2-week follow-up, weighting of individual symptoms and signs, and level of expertise (discrimination and consistency).Ethics and disseminationApproval has been obtained from the UCL Research Ethics Committee (8675/002) and local approvals will be obtained as appropriate. Results will be published in peer-reviewed journals using an open access format and presented at academic conferences. We will also publicise our findings on the Marie Curie website.Trial registration numberNCT03360812; Pre-results.

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