The full  Polybalm Scientific Study.  Polybalm is the only natural remedy to be scientifically designed, prepared and evaluated in a major government back UK randomized controlled trial (RCT).This summary was taken from the study protocol and the presentation at the American Society for clinical Oncology Conference 2017 . 

Background

Nails are made by living stem cells and, because they are dividing rapidly, are especially susceptible to chemotherapy¹. As a consequence, disfiguring nail damage is common, especially following regimens containing taxanes used for men and women with breast and prostate cancer. The type and severity of damage is variable, but most intravenous regimens can cause ridges in nails, which correspond to the timings of chemotherapy episodes known as ‘Beau’s lines’. More pronounced chemotherapy nail damage leads to discolouration, brittle nails, acute paronychia, onycholysis and sometimes even complete loss of the nail. This damage is often unsightly and contributes to body image issues during chemotherapy². More serious consequences include pain, which can limit activities of daily living, and secondary infection. This is of particular concern when patients are also neutropenic as the nails could be a source of systemic infection.

In addition to the killing of rapidly proliferating nail stem cells, damage is also thought to be due to chemotherapy’s anti-angiogenetic and neurogenically mediated inflammatory properties^5,6,7. If marked, the nails can separate from the bed causing pain, secondary bacterial and fungal infections considerably increasing damage to the nail^5,6,7.

A variety of anecdotal strategies are advised to patients during chemotherapy including nail hygiene, wearing nail varnish and avoiding trauma. 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. 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 extremities^8,9.

Many patient advocacy groups advise massaging moisturising balms into the nail bed, based on assumptions that oiling skin around the cuticles could improve compliance, thus preventing splitting which can be a route for infection and damage the nail bed. Although this seems intuitively beneficial there are no studies to support this practice or advise which balms to use. Patients are also often advised to wear nail varnish despite the knowledge that nail polish removers dry the nails. Likewise, there were no previously published prospective trials to support this practice during chemotherapy, or in an otherwise healthy population.

Development of the investigational balm (polybalm)

The chose of essential oils and waxes were made following an extensive scientific review of the laboratory and clinic data, by the clinical trial trials scientific committee. Following a review of several hundred potential candidates the four oils and four bases were selected not only for their individual properties but that they worked in synergy with each other to ensure their health advantages were complementary and exploited to the full.

The committee itself was unique in that, for the first time, it brought together traditional medical scientist, experienced oncologists and nurses with natural complementary therapist, qualified herbalists and nurses from around the UK all working together with patients themselves. This team then collaborated closely with the National Lifestyle and Behavioural change work stream of the, Department of Health backed, National Cancer Research Network, advisors from the Department of Biological Science at Coventry University and ethics committees from Bedford and Cambridge University Hospital trusts.

Once the ingredients were selected, meticulous care was given to ensuring the correct types and quantities of oils to ensure they could not irritate the skin. The bases contained cold pressed extra virgin olive oil, organic beeswax, unrefined cocoa butter and unrefined organic shea butter. The essential oils included Gaultheria procumbens, lavandula officinalis, eucalyptus globulus, tarchonanthus camphoratus. 

How these oils prevent chemotherapy induced nail damage:

The waxes and oils in polybalm are particularly rich in phytochemical especially the phenolic polyphenols group. In addition to they basic abilities to mosturizing the skin and prevent drying, splitting or cracking of the nail, they are known to have anti-inflammatory and anti-oxidant properties^1,2,3. It was hypothesized for the polybalm trial that oils with these properties, applied locally to the nail bed, would be sufficient absorption to act as a local antidote to the chemotherapy, preventing damage to the proliferating stem cells. In addition their anti-microbial properties would help prevent secondary infection so overall keeping the nail healthy and intact

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 180 fold 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.  The precise mode of action of this investigational balm would require further evaluation to elucidate and it would be interesting to investigate whether combination with nail bed cooling could further reduce the risk of this distressing toxicity in all patients.