Men and women receiving chemotherapy endure a host of troublesome side effects that affect their ability to perform simple activities of daily living. One, rather distressing, toxicity is nail damage (Onycholysis), which can affect up to half especially those receiving a commonly used category of drug called taxanes1,2,3. Initially the nails feel hot, sensitive and painful, then ridges appear followed by splitting and separation of the nail from the nail bed. This breakdown of the normal anatomy leads to secondary fungal and bacterial infection that causes further misery and damage.
Current practices:
Supervising oncologists often reduce the
dose of chemotherapy when nail damage gets too distressing but this may reduce
the beneficial effects of chemotherapy. Oncology nurses advise anecdotal
strategies including nail hygiene, wearing nail varnish and avoiding trauma
with little or no evidence of success. Cooling the nails bed with iced water
helps to reduce its severity4. Commercially available cooling gloves
are available but they are not particularly popular among UK chemotherapy
nurses as they cover the veins of the hands and prevent assessment of the
patient's extremities4,5,6.
Rationale
for the UK Polybalm study:
- Anti-inflammatory
- Analgesic
- Anti-oxidant
- Enhance DNA repair
- Anti-bacterial and anti-fungal
- Moisturising and hydrating
What
is polybalm?
In contrast to the ingredients of conventional cosmetics, the UK manufacturers
of polybalm only used unrefined oils, which were cold pressed or gradually warmed
avoiding damage to their phytochemical content. The bases of extra virgin olive
oil, organic beeswax, unrefined organic cocoa and shea butters. The essential
oils included Gaultheria procumbens, lavandula officinalis, eucalyptus
globulus, tarchonanthus camphoratus. They wanted to avoid any potential
iritants so excluded any man made chemical such, preservatives, colours,
parabens, sulphates or petroleum.
60 men and women
receiving chemotherapy for breast or prostate cancer were randomised to apply
either a simple petroleum moisturising balm to their nail bed 2-3 three times a
day or the investigational balm now known as polybalm. None of the patients,
doctors, research team or statistician knew which balm was assigned to which
participant. The health of the nails was measured by 4 independent tools. Two
completed by the patient concerning severity of symptoms and how they affected
QOL and two by physicians assessing the physical disfigurement.
Results:
There was a 180 fold difference in patient recorded QOL and an 11 fold difference in physician recorded disfigurement but both differences were highly statistically significant in all scores (unpaired T-test p<0.00001). There were no reported allergies or adverse events related to either creams. Only patients in the polybalm group had some nail changes also suffered from other severe chemotherapy complications including neutropenic sepsis, diarrhea and peripheral neuropathy13.
There was a 180 fold difference in patient recorded QOL and an 11 fold difference in physician recorded disfigurement but both differences were highly statistically significant in all scores (unpaired T-test p<0.00001). There were no reported allergies or adverse events related to either creams. Only patients in the polybalm group had some nail changes also suffered from other severe chemotherapy complications including neutropenic sepsis, diarrhea and peripheral neuropathy13.
Conclusion:
The polyphenol rich essential
oils and plant-based waxes in this nail bed balm profoundly reduced
chemotherapy related nail damage and improved nail related quality of life
compared to a plain petroleum based balm. The significant improvement in nail
related quality of life will be welcomed by patients suffering this unwelcome
toxicity which would otherwise significantly effect up to half of people
receiving chemotherapy.
Footnote:
This study was audited to comply with good clinical practice guidelines and Cambridge University Central Research Ethics Committee approval. It was registered with the Health Research Authority. The balms were made specifically for this study by a UK registered manufacturer and European product cosmetic test were performed to fully comply with European Union Cosmetics Standards (ref: 76/768/EEC). No member of the research team received payments to recruit patients into the study. Although this was a scientific evaluation, the FDA and MHRA classed them as a cosmetic, so cannot be recommended for any medical condition or claim health benefits. The investigation balm should not be considered as an alternative medical treatment and should not be used against medical advice. The protocol was in the public domain and the balm, named after the clinical trial, is now distributed by an independent organization (polybalm.com) that has no connection to the trials unit.
This study was audited to comply with good clinical practice guidelines and Cambridge University Central Research Ethics Committee approval. It was registered with the Health Research Authority. The balms were made specifically for this study by a UK registered manufacturer and European product cosmetic test were performed to fully comply with European Union Cosmetics Standards (ref: 76/768/EEC). No member of the research team received payments to recruit patients into the study. Although this was a scientific evaluation, the FDA and MHRA classed them as a cosmetic, so cannot be recommended for any medical condition or claim health benefits. The investigation balm should not be considered as an alternative medical treatment and should not be used against medical advice. The protocol was in the public domain and the balm, named after the clinical trial, is now distributed by an independent organization (polybalm.com) that has no connection to the trials unit.
References:
- Minisini AM et al:
Taxane-induced nail changes. Ann Oncol 14:333-337, 2003
- Battegay EJ: Angiogenesis:
Mechanistic insights. J Mol Med 73:333-346, 1995
- Wasner G et al:
Docetaxel-induced nail changes: J Neurooncol 58:167-174, 2002
- Ding & Thomas: Cooling
for chemo onycholysis. Clin Foc Can Med 2(1):18, 2010
- Scottie: Frozen glove to
prevent docetaxel onycholysis. JCO 23(19) 4424, 2005
- Ishiguro: Freezing for
docetaxel nail toxicity. Sup Care Can 20:2017-2024, 2012
- Delaquis: Antimicrobial
activity of plant oils. Int J Food Microbiol 74(1):101 2002
- Smith-Palmer:
Antimicrobial plant oils. Applied Microbiol 26(2):118-22, 2002
- Baratta: Antimicrobial
& antioxidant essential oils. Flav & Frag J 13(4):235, 2001
- Radava. Herbs protect
cells from UV radiation Pharmacogn Rev. 2011 5(10): 164
- Mao-Qiang: Topical plant
extracts & inflammation. Evid Based Com Alte Med. 2012
- Baliga: Chemoprevention of
botanicals. Phytochem Photobiol Sci. 2006, 5(2):243.
- Thomas R
et al. A double blind RCT of a polyphenolic rich plant balm for
onycholysis – the UK Polybalm Trial. 2017 ASCO Proceedings Abstract:101003