The PolyBalm Study Version 1.0
Research type
Research Study
Full title
A double blind, randomised evaluation of nail bed balms to prevent chemotherapy-induced onycholysis – The PolyBalm Study
IRAS ID
151716
Contact name
Madeleine Williams
Contact email
Sponsor organisation
Bedford Hospital NHS Trust
Clinicaltrials.gov Identifier
2015-001866-24, EudraCT
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The discomfort of nail damage is common amongst patients receiving chemotherapy, especially those receiving taxanes. Patient advocacy groups advise massaging the nail bed with a balm to maintain moisture, prevent skin splitting and possible damage to the nails. There are no published prospective trials to support their use during chemotherapy, or in an otherwise healthy population. Likewise, there is no guidance on the type of balm to use. Natural plant-based waxes and essential oils have anti-inflammatory and anti-microbial properties, and it is hypothesized that these have added benefits other than simply oiling the nail bed with the more commonly used hydrocarbon-based balms.
This study compares the incidence of nail damage following regular use of a nail bed balm made from natural wax bases and essential oils, to a petroleum-based control.
A double blind, placebo controlled, randomised trial involving 50 patients receiving chemotherapy, with at least 25 receiving taxotere, the chemotherapy agent most likely to cause onycholysis. The Dermatology Life Quality Index nail health questionnaire will be completed by participants at screening and after the final cycle of chemotherapy. The toxicity score and grading of the visual damage, will be independently measured and statistically evaluated at Cranfield University.
If these hypotheses are proved correct, this technique could prevent the discomfort and risk of nail damage experienced by many thousands of patients receiving chemotherapy every year.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
15/EE/0357
Date of REC Opinion
8 Dec 2015
REC opinion
Further Information Favourable Opinion