The UK PolyBalm Study
A double blind, randomised evaluation of a polyphenol rich natural nail bed balm to prevent chemotherapy-induced damage
.Summary: This UK study, designed with the National Cancer Research Institutes (NCRI) clinical trials development committee, aims to find a way to help reduce the incidence and severity of nail damage associated with chemotherapy.
Disfiguring nail damage is common after chemotherapy, especially the taxane category, often used in the treatment of breast, prostate and lung cancer. Nail damage can be unsightly and contributes to body image issues but also to more serious consequences include pain, which can limit activities of daily living, and lead secondary fungal and bacterial infections 1,2.
We have previously published a report showing that cooling the nails bed with pots of iced water helps to reduce its severity4. Understandably, the practice has never caught on within the confines of a busy chemotherapy unit. Some commercially available cooling gloves are available but they are not particularly popular among UK chemotherapy nurses as they may cover the veins of the hands and prevent assessment of the patient's extremities7.
Nails are made by living cells in the nail beds which, because they are dividing rapidly, are especially susceptible to chemotherapy. Particular sensitivity to taxotane chemotherapy is thought to be due to their anti-angiogenetic and neurogenically mediated inflammatory properties3,4.
Patient advocacy groups advise wearing nail varnish, massaging the nail bed with a balm to maintain moisture, prevent skin splitting in the hope it reduces damage to the nails. There are no published prospective trials to support the practice use during chemotherapy, or in an otherwise healthy population. Likewise, there is no guidance on the type of balm to use.
How could the ingredients of this balm help the nails - The hypothesis?
Oiling skin around the cuticles moisturizes and improves the compliance of the skin, preventing splitting which can be a route for infection and hence further damage to the nail beds. Using natural oil bases, rather than some synthetic creams, avoids chemicals such as perfumes, parabens, preservatives or colours, which may be irritating. The natural bases and essential oils were selected for their anti-inflammatory, anti-oxidant and anti-microbial properties.
This is a double blind, randomised trial involving 60 patients receiving chemotherapy. Half will receive the polyphenol rich balm and the other half a simple petroleum based moisturiser. The study has been designed in this way to prevent biased results; neither the participant nor the research team (including your doctor), will know which of the creams is the natural wax-based nail cream being tested, and which is the petroleum-based cream, until after the study has finished. All patients has started cytotoxic chemotherapy (or about to start within 2 weeks), at least 50 receiving taxanes (taxotere or taxol). Participants are asked to massage a small amount onto the nails beds three times a day. Assessment of nail damage were taken at the start and at the end of the study (3 weeks after the last injection of chemotherapy).
What is measured - trial end points?
The scientific trial team included cancer doctors (0ncologist), skin doctors (dermatologists), nurses, statisticians as well as patients themselves. All the medical staff involved in the study had Good Clinical Practice (GCP) research training.
All data was stored on a password-protected Bedford Hospital NHS Trust computer. Once the data has been completed, the database will be ?locked? in a password-protected file. The database will be sent for independent statistical analysis to Michael Cauchi from Cranfield University, Bedfordshire. He will not know which patients received the active cream and which placebo when he analyses the data ? a further ?blinded? assurance.
Data and efficacy endpoints will be summarised using descriptive statistics (number of observations, mean, standard deviation, median, minimum and maximum). For endpoints subjected to formal statistical analysis, the results of the analysis will be summarised and 95% confidence intervals for treatment differences will be presented and displayed as box-and-whisker plots which would also indicate the variability in the data. All efficacy variables will be analysed for the intention-to-treat population. No adjustment for multiple comparisons will be made. The photographs will be stored digitally with the future intent of subjecting to multivariate data analysis in conjunction with image processing in order to correlate the human observations with the machine learning algorithms.
Independent advice or further information on participating in a clinical trial in general you can contact: Macmillan Cancer Support on 0808 808 0000, or visit their website www.macmillan.org.uk; The National Institute for Health Research (NIHR), email: firstname.lastname@example.org, or visit their website www.nihr.ac.uk The local research manager lead is Madeleine Williams, Tel: 01234 795787. Email: email@example.com The chief investigator for this trial is Dr Sarah Smith, Consultant Oncologits Bedford and Addenbrooke's Cambridge University NHS Trusts.
The abstract of the final trial data was presented at ASCO 2017 - see results. The product polybalm is now made by an UK manufacturer which has no connection with the trials unit which ensures its availability nationally and internationally.
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