I’m here at ASCO to present a double-blind randomised study which investigated a natural plant based balm to try and act as a local antidote to severe nail toxicity during chemotherapy. There’s a number of drugs that do this but the one most likely is called Taxotere which is one of the most commonly used chemotherapy drugs at the moment, it’s used for breast, prostate and lung cancer. About 50% of patients get quite severe and distressing nail damage where the nails can even come off in extreme cases and you can get secondary infections.
At what point does the balm start to help that out and what are the benefits that you’ve seen?
The background to the study is we set up a scientific committee to try and find the therapies which would reduce this damage. There are various things already available like cooling the nail beds but they’re not particularly practical. So what we did amongst our herbalists and plant scientists is try to work out why you get nail damage. It’s a combination of damaging the proliferating cells, you get over-inflammation, so excess inflammation, locally and you get secondary infections. So we developed over about two or three years a balm with various natural essential oils etc. which have anti-inflammatory, antioxidant properties. We then got a UK company to develop it for us and set up a randomised trial with 60 patients, 30 in each arm – 30 on placebo, 30 with the intervention. They used it from the start of chemotherapy until the end and we were very pleased to see when we opened up the blinding that virtually no patient in the active group got any nail damage at all. So the hypothesis was it would get absorbed into the nail beds, reduce the toxicity from Taxotere, stop it damaging the fast growing cells and prevent over-inflammation and secondary infection and it turned out to be completely correct.
A significant boon for quality of life then?
Definitely because one of the endpoints of the trial was measuring patient nail-related quality of life, in fact that’s the one we felt was most important because it’s what patients experience. That was very highly significant, in fact in the polybalm group, we call it the polybalm group, they actually reported an improvement in nail related quality of life by the end of chemotherapy on average. So that’s one distressing side effect patients now no longer need to worry about. They’re still going to get everything else related to chemo but that’s one we’re very happy to feel we’ve contributed in that arena.
The hair cooling systems tend to be the one that everyone focusses on with hair loss being immediately visible but I can imagine the sensation of nail deterioration being equally concerning to patients so it’s good that they have this. Are there any plans to take this forward with further expansion or going towards licensing the item?
Yes, what we do as a trials unit is try to get the evidence for the wider community, patients, so they can make informed decisions. But at the end of the day these plant-based products are never going to be licensed. The reason is the FDA and the MHRA aren’t really happy with the amount of different chemicals you have within them and even if you were to measure each one and record it accurately there’s so much diversity on a month by month basis depending on where the oils were sourced from and the weather conditions. So they will never become prescribable drugs so there’s no intention for us to try to get a licence for this, it would be too difficult. It will be an over the counter remedy, for the sake of another word, which patients can then access themselves if they want to. The important thing to remember is in the trial patients used it before they got the nail damage. What we’re a little bit concerned about and what we had meetings with the ASCO Survivorship Committee is we need to get the word out there that if you decide you want to use something like this you have to use it from the start. What might happen is patients will start chemotherapy, they’ll get nail damage, they’ll then Google things and use it, it might be too late then.
Was there any other feedback from the Survivorship Committee? Being as I can imagine they have some very insightful experiences themselves?
Yes. I was contacted by Charles Loprinzi who is head of the Survivorship Programme in ASCO today. He’s very keen to do another collaborative study where we combine the polybalm cream with nail cooling. He’s got quite a specialised system which the nurses can still look at the nail beds and this system which currently is available the nurses don’t like because it covers the hands and they can’t see the extremities. That’s quite exciting. Saying that, we hardly got any toxicity in the polybalm group but there was still some so if we can eliminate it completely that would be great. They have enormous resources in the States so if we can do the next trial with them it will be great for our trials unit and great for research in this area which is growing.