The Polybalm Study
The full Polybalm study design can be viewed on the Official Trials Website . Polybalm is the only natural remedy that was scientifically designed, formulated and tested in a major UK government randomized controlled trial (RCT) . 151716 ).
Read the full scientific preview: May 2018
Nails are made of living stem cells, and because they divide rapidly, they are especially susceptible to chemotherapy 1
In addition to the destruction of rapidly proliferating nail stem cells, the damage is also thought to be due to the antiangiogenetic and neurogenically mediated inflammatory properties of chemotherapy 5,6,7 . If marked, the nails can separate from the bed causing pain, secondary bacterial and fungal infections greatly increasing nail damage 5,6,7 .
A variety of strategies are anecdotally recommended to patients during chemotherapy, including nail hygiene, use of nail polish, and trauma prevention. We have previously published a report showing that cooling the nail bed with containers of ice water helps reduce its severity 4 .< s2> Understandably, the practice has never caught on within the confines of a busy chemo unit. Commercially available cooling gloves are available, but they're not particularly popular with UK chemo nurses United, since they can cover the veins of the hands and avoid the evaluation of the patient's extremities 8.9 .
Many patient advocacy groups advise massaging moisturizing balms into the nail bed, based on the assumption that applying oil to the skin around the cuticles might improve compliance, thereby preventing breakage, which which can be a route of infection and damage to the nail bed. Although this seems intuitively beneficial, there are no studies to support this practice or advise which balms to use. It is also often recommended to patients who apply nail polish despite knowing that nail polish remover dries out the nails. Similarly, there were no previously published prospective trials to support this practice during chemotherapy or in a healthy population
Development of research balm (polybalm)
The choice of essential oils and waxes was made after an extensive scientific review of clinical and laboratory data by the clinical trials scientific committee. After a review of Several hundred potential candidates, the four oils and four bases were selected not only for their individual properties, but also because they worked in synergy with each other to ensure that their health benefits were complementary and maximized.
The committee itself was unique in that for the first time it brought together traditional medical scientists, oncologists and experienced nurses with complementary natural therapists, qualified herbalists and nurses from across the UK, all working together with patients themselves. This team then collaborated closely with the National Lifestyle and Behavior Change Workstream of the National Cancer Research Network supported by the Department of Health, advisers to the Coventry University Department of Biological Sciences and ethics committees of Bedford and Cambridge University Hospital trusts.
Once the ingredients were selected, meticulous care was taken to ensure the correct types and amounts of oils to ensure they would not irritate the skin. The foundations contained extra virgin olive oil cold pressed, organic beeswax, raw cocoa butter, and raw organic shea butter. Essential oils included Gaultheria procumbens, Lavandula officinalis, Eucalyptus globulus, Tarchonanthus camphoratus; the full scientific summary of its properties can be viewed on the formal essays website.
How these oils prevent chemotherapy-induced nail damage:
Polybalm waxes and oils are especially rich in phytochemicals, especially in the group of phenolic polyphenols. In addition to their basic abilities to moisturize skin and prevent nails from drying out crack or crack, they are known to have anti-inflammatory and antioxidant properties 1,2,3 . It was hypothesized for the polybalsam trial that oils with these properties, applied locally to the nail bed, would be sufficiently absorbable to act as a local antidote to chemotherapy, preventing damage to the nails. proliferating stem cells. In addition, its antimicrobial properties would help prevent secondary infections, so, in general, they would keep the nail healthy and intact 1,2,3 .
Authenticity and quality control of the study:
The research balm was manufactured specifically for this study by Power Health Ltd and cosmetic testing and European product certification was performed by Advantis Laboratories Ltd. They fully comply with European Union cosmetic standards (license 76/768/EEC). The trial committee collaborated closely with the National Lifestyle and Behavior Change Workstream of the National Cancer Research Network, supported by the Department of health. The committee included independent advisers from the Coventry University Department of Biological Sciences, was governed by the Cambridge University Ethics Committee and was registered with the NHS Health Research Authority. , for its acronym in English) and all the results were analyzed by independent statisticians to guarantee the best possible, robust and authenticated design.
Sixty-one men and women who received chemotherapy for breast or prostate cancer at one of the hospitals affiliated with the University of Cambridge (Bedford) during a 2-year recruitment period. After written informed consent, they were randomized (50:50) to apply either a petroleum-based moisturizing balm to the nail bed three times daily or the investigational balm now known as polybalm, named for the trial.
Trial Outcome Measurements: Nail health was measured with 4 independent tools and none of the patients, clinicians, research team or statistician knew which balm was assigned to which participant.
Patients recorded their own nail health using the validated Dermatology Life Quality Questionnaire (DLQQ) plus a simple linear severity scale (LSS) that emphasized how nail damage affected your daily activities and quality of life.
Physicians recorded nail physical condition using the Validated Nail Psoriasis Index (NPSI) plus another simple linear severity scale (LSS). In addition to directly assessing nail damage, photographs of the nails were sent to 3 doctors from other departments and hospitals for further independent verification.
In all but 1 of the 30 patients in the polybalm cohort, there was virtually no nail damage compared with more than half who experienced significant damage and distress in the placebo group. In fact, the average patient reported that nail-related quality barely changed in the polybalm group, and the linear scale actually improved between the start and end of chemotherapy. No allergies were reported and no adverse events related to either cream. Patients in the polybalm group who still had some nail changes also had other serious complications of chemotherapy, including neutropenic sepsis, diarrhea, and The Bottom Line: The polyphenol-rich essential oils and plant-based waxes in this nail bed balm profoundly reduced damage in chemotherapy-related nails and improved nail-related quality of life compared to a simple petroleum-based balm. 180-fold improvement in nail-related quality of life will be good received by patients suffering from this unwanted toxicity that would otherwise significantly affect up to half of people receiving chemotherapy. The precise mode of action of this investigational salve would require further evaluation to elucidate and it would be interesting to investigate whether the combination with nail bed cooling could further reduce the risk of this distressing toxicity in all patients.
The Bottom Line: The polyphenol-rich essential oils and plant-based waxes in this nail bed balm profoundly reduced damage in chemotherapy-related nails and improved nail-related quality of life compared to a simple petroleum-based balm. 180-fold improvement in nail-related quality of life will be good received by patients suffering from this unwanted toxicity that would otherwise significantly affect up to half of people receiving chemotherapy. The precise mode of action of this investigational salve would require further evaluation to elucidate and it would be interesting to investigate whether the combination with nail bed cooling could further reduce the risk of this distressing toxicity in all patients..