When I first licensed the North American marketing rights to Caphosol® in October 2006 (see press release), I had no idea that nearly a decade later I would be a customer. The product is intended to treat some of the common side effects from cancer chemotherapy and radiation – both oral mucositis (inflammation of the mucous membranes in the mouth with symptoms ranging from redness to severe ulcerations) and xerostomia (dry mouth). While these side effects can occur as a result of various treatments, they are particularly prevalent in head and neck cancer patients undergoing chemoradiation like me.
It was disheartening that so many years after its commercial introduction, no physician I spoke with had heard of Caphosol. After a fair amount of nagging and discussion, I was finally able to secure a prescription this week and locate a pharmacy that carried the product in advance of starting treatment this Monday (special shout out to my wife, former colleague June, and her colleague Ken for their assistance in this regard!). This is important, as one the key clinical studies supporting Caphosol’s efficacy incorporated the product at the start of therapy. In other words, Caphosol was used before the incidence of oral mucositis or xerostomia – as a preventative therapy. The trial demonstrated that Caphosol was able to reduce the severity of oral mucositis, decrease pain and associated use of opioid analgesics, and reduce the days of neutropenia (abnormally low concentration of white blood cells in the blood) – see journal abstract from the study.
To be perfectly clear – I have absolutely no financial interest in Caphosol. However, I am a believer in the product and did extensive due diligence as part of the licensing process. As a result, I hope that this blog post can help other patients at risk for oral mucositis and/or xerostomia learn about Caphosol. While there are other agents used in the treatment of oral mucositis and xerostomia, Caphosol is unique in that the product’s efficacy was demonstrated in a randomized, placebo-controlled clinical study. Perhaps the most significant distinguishing feature of Caphosol is the high concentrations of calcium and phosphate ions. Why is this important? Calcium ions play a crucial role in several aspects of the inflammatory process, the blood clotting cascade, and tissue repair, and phosphate ions may be a valuable supplemental source of phosphates for damaged mucosal surfaces. No other product on the U.S. market is formulated this way or has the proven clinical benefit that Caphosol does.
As you can see in the accompanying image, Caphosol is supplied in a carton with 30 doses. A dose is comprised of two ampules of aqueous solutions, one containing a phosphate solution and the other containing the calcium solution. The two solutions are combined in a glass and patients are instructed to swish the resulting mixture in the mouth thoroughly and then expectorate (spit out). This process can be repeated 2-10 times per day, although four doses per day is what was used in the clinical trial.
I will report on my experience with Caphosol (good, bad, or indifferent) throughout my chemoradiation treatment over the next 6-7 weeks. My first round of chemotherapy and radiation therapy starts this Monday and Tuesday. As the treatments occupy most the day, it may not be until later this week that I post any blog updates.