Rastogi, M., Khurana, R., Revannasiddaiah, S., Jaiswal, I., Nanda, S.S., Gupta, P., . . . Bhatt, M.L. (2016). Role of benzydamine hydrochloride in the prevention of oral mucositis in head and neck cancer patients treated with radiotherapy (> 50 Gy) with or without chemotherapy. Supportive Care in Cancer. Advance online publication. 

To evaluate the role of benzydamine in the prevention of mucositis in patients receiving more than 50 Gy of radiation therapy

Patients were stratified according to receiving radiotherapy or radiotherapy and chemotherapy, and then randomly assigned to control or treatment with benzydamine. All patients were advised to use saline mouth rinses, and those in the treatment group also used 0.15% benzydamine hydrochloride rinse. Both groups were to rinse and gargle with the mixture four to six times daily. Patients were examined weekly until four weeks after completion of the treatment.

• N = 120   
• AGE RANGE = 19–90 years
• MALES: 87.5%, FEMALES: 12.5%
• CURRENT TREATMENT: Radiation, combination radiation and chemotherapy
• KEY DISEASE CHARACTERISTICS: All had head and neck cancer.
• OTHER KEY SAMPLE CHARACTERISTICS: Radiotherapy dosages ranged from 56–70 Gy.

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: India

PHASE OF CARE: Active antitumor treatment

Randomized, controlled trial

• Common Terminology Criteria for Adverse Events (CTCAE) toxicity, version 4
• World Health Organization (WHO) mucositis grading scales

Patients receiving radiotherapy alone who used benzydamine had a lower prevalence of grade 3 mucositis compared to controls (p = 0.038); however, control patients receiving only radiotherapy also had a longer duration of radiation treatment (p = 0.042, 56 versus 44 days). No significant difference in mucositis outcomes occurred among those receiving both chemotherapy and radiation. Control patients in this group had a longer duration of radiation therapy.

Benzydamine prophylaxis appears to be effective to reduce the severity of oral mucositis among patients receiving radiotherapy alone for head and neck cancer. Effects for patients receiving both chemotherapy and radiation therapy were not seen.

• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Measurement/methods not well described
• Exact measure used in analysis and timing of measurement used not stated
• In both treatment types, patients in the control group had a significantly longer duration of radiation therapy.

Oral rinses with benzydamine were helpful to reduce the prevalence of severe mucositis among patients receiving radiation therapy for head and neck cancer. It is unclear if benzydamine can also be helpful for patients receiving combination chemotherapy and radiation therapy.