Two separate oral rinses were found to reduce pain from oral mucositis and mouth sores in patients receiving radiation therapy for head and neck cancers when compared to placebo. The finding comes from the Alliance A221304, a phase 3 multicenter, randomized, double-blind, placebo-controlled trial of 227 head and neck cancer patients undergoing definitive radiotherapy.
Study participants were randomized 1:1:1 to receive either doxepin mouthwash (N=78), “magic mouthwash” (diphenhydramine-lidocaine-antacid)(N=75), or placebo (N=74).
The intervention protocol consisted of two cycles. In cycle 1, the coordination of the timing of radiotherapy and administration of the study mouthwashes was not required; cycle 2 was an optional continuation phase in which the rinse was administered every 4 hours up to 7 days.
The primary outcome was reduction in total oral mucositis pain, defined by the area under the curve and adjusted for baseline pain score. Results showed that during the first 4 hours after treatment, total pain decreased by 11.6 points in the doxepin group and by 11.7 points in the diphenhydramine-lidocaine-antacid mouthwash group, compared with 8.7 points in the placebo group.
The mean differences in pain reduction by the area under the curve for both mouthwashes, however, were less than the minimal clinically important difference of 3.5 points: 10.4 points for doxepin (interquartile range [IQR], 4.5-15.3 points, P =.02); 11.5 for diphenhydramine-lidocaine-antacid (IQR, 5.4-17.0 points); and 8.7 for the placebo (IQR, 2.0-13.0 points, P =.004).
Fatigue was the most commonly reported adverse event. Three patients (4%) in the doxepin mouthwash group, 3 (4%) in the diphenhydramine-lidocaine-antacid mouthwash group, and 2 (2%) in the placebo group reported a maximum grade 3 adverse event.
Terence Sio, MD, and study co-author said, “Unfortunately, healthy cells in your mouth also divide and grow rapidly, and may be damaged during radiation therapy, which can cause discomfort. We’re glad to have identified a proven method to help treat the discomfort of this side effect.”
The authors conclude their study stating that, “further research is needed to assess longer-term efficacy and safety for both mouthwashes.”
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