Effectiveness Not Established

Irsogladine Maleate

for Mucositis

Irsogladine maleate is a synthetic drug that has antiviral activity and appears to have some mucosal protective effects. Oral rinsing with dissolved irsogladine maleate was studied for its effect on oral mucositis.

Research Evidence Summaries

Nomura, M., Kamata, M., Kojima, H., Hayashi, K., & Sawada, S. (2013). Irsogladine maleate reduces the incidence of fluorouracil-based chemotherapy-induced oral mucositis. Annals of Oncology, 24, 1062-1066.

Study Purpose

To evaluate the effects of irsogladine maleate (IM) on fluorouracil-induced oral mucositis

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to irsogladin maleate (IM) or placebo or normal saline. Treatment was administered orally twice a day, 4 mg/day beginning on the first day of chemotherapy and continued for 14 days. Oral rinse with sodium gualenate hydrate, standard care was also used 4 times daily. Other oral treatments were not allowed. Patients were assessed on days 1, 3, 5, 8, 10, 12, 14, 21, and at the end of the chemotherapy cycle.

Sample Characteristics

The sample was comprised of 66 patients. Age in the IM arm: 35-79, in the placebo arm 30-79 .

MALES (%) IM arm n = 20 and placebo arm n = 21; FEMALES (%) IM arm n = 13 and placebo n = 12.

KEY DISEASE CHARACTERISTICS: 83% of all patients had tumors in the head and neck or esophagus.

OTHER KEY SAMPLE CHARACTERISTICS: Most patients had stage III-IV tumors. Chemotherapy included 5FU and cisplatin or nedaplatin.


SITE: Single site


LOCATION: Kansai Medical University, Hirakata, Japan

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment


Study Design

Double blind randomized placebo controlled

Measurement Instruments/Methods

WHO grading of oral mucositis


Incidence of oral mucositis was 27.3% in the IM group and 72.7% in the placebo group (hazard ratio 0.14, 95% CI 0.05-0.42, p < 0.001). Changes in oral mucositis showed that severity scores were significantly lower in the IM group on multiple study days (p < 0.05). No adverse events related to IM were found.


This study adds to the evidence suggesting that IM is useful in the prevention of oral mucositis.


Small sample (<100)

Key sample group differences that could influence results

Other limitations/*explanation: There is no information regarding patient adherence to the protocol for frequency of medication use.

Nursing Implications

This study showed that irsogladine maleate use was associated with reduced incidence and severity of oral mucositis in these patients receiving chemotherapy associated with development of mucositis. There are few treatments that have been shown to be effective for mucositis prophylaxis. Given the promising results in this relatively small study, further research is warranted.