Phase 3 clinical trial results showed that certain mouthwashes benefit and reduce pain in patients with oral mucositis.
Patients and health care providers don’t have a problem with understanding oral mucositis, rather they have concerns associated with what will work to treat it, according to Dr. Terence Sio, of the Mayo Clinic.
A major misconception is if mucositis-specific mouth washes will work to alleviate pain for patients. And since many of the mouthwashes are not covered by insurance, health care providers may be skeptical, Sio, who is a radiation oncologist and assistant professor of radiation oncology, explained in an interview with CURE®. “That means patients could pay $200 to $300 out of pocket,” he said.
But in a study led by Sio and published earlier this year in JAMA, he and a team of researchers discovered that doxepin mouthwash or diphenhydramine-lidocaine-antacid mouthwash may be effective in reducing radiotherapy-related mucositis pain.
The phase 3 study is the first to examine these mouthwashes versus placebo mouthwash in nearly 300 patients who underwent head and neck radiotherapy. Ninety-two patients were randomly selected to receive doxepin mouthwash, 91 patients to diphenhydramine-lidocaine-antacid and 92 patients to placebo.
The researchers’ goal was to see if the mouthwashes reduced oral mucositis pain. They learned that using doxepin mouthwash or diphenhydramine-lidocaine-antacid mouthwash significantly reduced oral mucositis pain during the first four hours after administration compared with placebo.
“Oral mucositis is more about symptomatic control,” Sio said, “and to help our patients going through with whatever they are experiencing like the pain or infection that we can treat with anti-fungal (medications).”
Patients can use the mouthwashes every four hours as needed, he added. And for those who develop esophagitis, which can cause burning and inflammation of the esophagus and be brought on by mucositis, they can swallow the mouthwash which may provide some relief.
“Oral mucositis is quite diminishing to the quality of life of our patients and should be addressed promptly,” Sio said. “Before the study, there was quite a bit of skepticism regarding if magic mouth wash will work or not, but now we show some efficacy for that but that is subject to further testing and clinical trials.”
If oral mucositis is not treated in a timely manner it could worsen and lead to other complications. For instance, Sio explained, patients could end up being hospitalized or needing a feeding tube if the side effect decreases their oral intake. Most importantly, it can interrupt cancer therapies, which might affect treatment outcomes.
Sio hopes his findings will help with updating recommendations and guidelines for treating oral mucositis. “We want to recognize that oral mucositis and related pain is a real burden for patients that are going through treatment,” Sio said. “Physicians and patients should be educated about the signs and symptoms with the commencement of therapies to catch it earlier rather than later.”