Use of two medicated mouthwashes reduced pain from oral mucositis during the first four hours after administration; however, the results were not deemed clinically different when compared with placebo.
Use of two medicated mouthwashes reduced pain from oral mucositis during the first four hours after administration; however, the results were not deemed clinically different when compared with placebo, according to study results published in JAMA.
Oral mucositis is a side effect from radiotherapy and chemotherapy, causing pain, and in turn, discontinuation of treatment for many with cancer. “Symptoms can be severe, and oral mucositis can lead to hospitalization and requirement of a feeding tube,” the researchers wrote. “More than 80% of patients develop oral mucositis during radiotherapy, and mouthwashes and systemic analgesic agents are frequently used to treat the condition.”
While a number of commercially-available combination mouthwashes exist, no trials support their use for oral mucositis induced by cancer treatment.
So, the researchers conducted a randomized phase 3 trial designed to evaluate whether a single dose of doxepin mouthwash (92 patients) or diphenhydramine-lidocaine-antacid mouthwash (92 patients) was more effective than placebo (92 patients) in reducing oral mucositis pain for patients undergoing radiotherapy to the oral cavity for head and neck cancer treatment.
Total pain reduction during the four hours after a single dose of the mouthwashes compared with placebo served as the primary endpoint, with a minimal clinically important difference being a 3.5-point change. Secondary endpoints included drowsiness, unpleasant taste and stinging or burning. All scales ranged from 0 (best) to 10 (worst).
Patients were a median age of 61 years, and the majority were men (79%). Only 227 patients completed treatment per protocol.
Mucositis pain during the first 4 hours decreased by 11.6 points in the doxepin mouthwash group, by 11.7 points in the diphenhydramine- lidocaine-antacid mouthwash group and by 8.7 points in the placebo group, for a 2.9-point difference between doxepin mouthwash and placebo and a 3.0-point difference between diphenhydramine- lidocaine-antacid mouthwash and placebo.
Patients who received doxepin mouthwash reported more drowsiness (by 1.5 points), unpleasant taste (by 1.5 points) and stinging or burning (by 4.0 points) compared with placebo.
Grade 3 side effects occurred in three patients who received the doxepin mouthwash, three patients with the diphenhydramine-lidocaine-antacid mouthwash and two patients with placebo. In addition, fatigue was reported by five patients in the doxepin mouthwash group and no patients in the diphenhydramine- lidocaine-antacid mouthwash group.
“Among patients undergoing head and neck radiotherapy, the use of doxepin mouthwash or diphenhydramine-lidocaine- antacid mouthwash compared with placebo significantly reduced oral mucositis pain during the first four hours after administration; however, the effect size was less than the minimal clinically important difference,” the researchers wrote. “Further research is needed to assess longer-term efficacy and safety for both mouthwashes.”