Randomized clinical trial of chlorhexidine versus placebo for prevention of oral mucositis in patients receiving chemotherapy

Abstract

Purpose/objectives: To test the effectiveness of a nurse-initiated systematic oral hygiene teaching program-PRO-SELF: Mouth Aware (PSMA)-in conjunction with two mouthwashes (0.12% chlorhexidine or sterile water) in preventing chemotherapy-induced oral mucositis.

Design: Randomized, double-blind, placebo-controlled, clinical trial.

Settings: 23 outpatient clinics and office practices in California.

Sample: 222 patients who were starting a cycle of mucositis-inducing chemotherapy.

Method: Participants were followed over three chemotherapy cycles. All patients were provided the PSMA program. Random assignment to a mouthwash occurred prior to the development of oral mucositis. Researchers used the Oral Assessment Guide to assess the patients oral cavities monthly (with the patients cycles of chemotherapy) and when patients reported any oral changes between cycles.

Main research variables: Type of mouthwash, incidence, days to onset, and severity of chemotherapy-induced oral mucositis.

Findings: No significant differences existed between the two mouthwashes in regard to incidence, days to onset, and severity of mucositis.

Conclusions: Because chlorhexidine (S20 per pint) was no more effective than water, a substantial cost savings can be realized by rinsing with water. Interestingly, the PSMA program appeared to reduce the incidence of mucositis from on a prior estimate of 44% to less than 26%.

Implications for nursing practice: A nursing prescription of a systematic oral hygiene program using water as a mouth rinse is cost efficient and may be effective in preventing oral mucositis.