Oral mucositis is a treatment limiting toxicity of
cancer therapy. The purpose of this study was to assess the impact of
doxepin oral rinse in the management of oral mucosal
pain in
cancer patients. Forty-one
cancer patients with oral mucosal
pain were provided a
solution of
doxepin (0.5%) for oral rinsing. Oral
pain was assessed prior to rinsing, and following rinsing for 4 h using a visual analogue scale (VAS). Adverse effects were recorded.
Doxepin rinse resulted in a reduction of
pain intensity of more than 50%, with
pain relief extending for more than 3 h with
pain not returning to baseline 4 h after rinsing. The rinse was tolerated by patients with mucosal damage, and had acceptable taste, and infrequent mucosal stinging with use. Some patients reported sedation after use, likely due to systemic absorption. The results of this single dose trial suggest that topical
doxepin rinse has significant ability to provide clinically significant
pain relief in patients with mucosal damage with an extended duration of effect.