Dodd, M.J., Dibble, S.L., Miaskowski, C., MacPhail, L., Greenspan, D., Paul, S.M., . . . Larson, P. (2000). Randomized clinical trial of the effectiveness of 3 commonly used mouthwashes to treat chemotherapy-induced mucositis. Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, and Endodonology, 90, 39–47. 

DOI Link

Study Purpose

To determine the efficacy of three different mouthwashes in the treatment of chemotherapy-related mucositis

Intervention Characteristics/Basic Study Process

All patients received the PRO-SELF Mouth Aware (PSMA) educational program from a nurse who was blinded to the intervention treatment. The program included didactic information, the development of self-care strategies, and nurse support in the treatment setting. Good oral hygiene was an emphasis of the program, and patients were provided with specific oral hygiene practices to follow during chemotherapy. Nurses contacted the patients via telephone every other day. Patients were randomly assigned to receive one of three possible intervention treatments that were given to the patient in 1-pint opaque plastic bottles. The interventions were either salt and soda, chlorhexidine, or magic mouthwash. Nurses received training in the PSMA program every six months. Patients used the mouthwash four times per day until symptoms resolved or for 12 days. Patients swished 20 mL of their intervention mouthwash for 20 seconds and spit. Mouthwash bottles were collected when symptoms resolved or on day 12, whichever came first, and remaining medication was measured to gauge patient compliance. Oral assessments began upon enrollment, and the first assessment was conducted by a physician or nurse. Patient-directed oral assessments continued thereafter, four times per day, or until mucositis resolved or for 12 days, whichever came first.

Sample Characteristics

  • N = 142  
  • MEAN AGE = 59.25 years
  • MALES: 36%, FEMALES: 64%
  • KEY DISEASE CHARACTERISTICS: Multiple types of cancer 

Setting

  • SITE: Multi-site    
  • SETTING TYPE: Outpatient    
  • LOCATION: United States

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Randomized, double-blinded clinical trial

Measurement Instruments/Methods

  • Oral Assessment Guide (OAG)

Results

There were no differences between any of the groups in the time to cessation of mucositis symptoms (F2,141 = .52, p = .59). The mean number of days to cessation of symptoms was 6.59 days in the chlorhexidine group, 7 days in the salt and soda group, and 7.17 days in the magic mouthwash group.

Conclusions

Although clinicians regularly use chlorhexidine mouthwash, this study demonstrates that there is no difference between treatments of salt and soda rinses and magic mouthwash as part of a treatment protocol for chemotherapy-induced oral mucositis. Participants in the magic mouthwash group reported the highest mean number of days to cessation of symptoms, indicating this is the least effective treatment of the three.

Limitations

  • Unintended interventions or applicable interventions not described that would influence results 
  • Other limitations/explanation: It is unclear what additional interventions for mucositis were used during the intervention period.

Nursing Implications

Educating patients about proper oral hygiene while receiving chemotherapy is important. Nurses should be aware, however, that there is no difference between chlorhexidine mouthwash, salt and soda rinses, and magic mouthwash, the three mouthwashes traditionally used in the clinical setting. As the least effective of the mouthwashes in terms of mean days to cessation of symptoms, magic mouthwash does not appear to be an effective intervention in the treatment of chemotherapy-induced oral mucositis.