Lalla, R. V., Gordon, G. B., Schubert, M., Silverman, S., Jr, Hutten, M., Sonis, S. T., et al. (2012). A randomized, double-blind, placebo-controlled trial of misoprostol for oral mucositis secondary to high-dose chemotherapy. Supportive Care in Cancer, 20, 1797-1804.

The purpose of this study was to determine if a misoprostol oral rinse would reduce the severity of mucositis in patients receiving high-dose chemotherapy for autologous stem cell transplant.

This multi-center study employed a randomized, double blind, placebo controlled, parallel-group design. Participants were assigned to the misoprostol arm or placebo arm. Subjects swished and gargled the misoprostol or placebo solution (in 15 ml of water), held it in their mouths for 60 seconds, and then swallowed. Administration began 45 min. to 2 hours before the initiation of the conditioning regimen and then every 8 hours until 24 hours after the conditioning regimen was complete. All subjects also received instructions on standard care and instructed not to use other oral care for 1 hour after the misoprostol or placebo solution. The Oral Mucositis Index was used to grade mucositis every 2 to 3 days.

The study was comprised of 48 patients, 22 in treatment arm and 26 in placebo group, with an age greater than or equal to 18 years.
MALES 30%, FEMALES 70%
KEY DISEASE CHARACTERISTICS: Lymphoma, multiple myeloma, or solid tumor patient undergoing autologous stem cell transplant.
OTHER KEY SAMPLE CHARACTERISTICS: Patients could not have been receiving cisplantin/carboplatin conditioning regimens or total body irradiation.

SITE: Multi-site

SETTING TYPE: Inpatient

LOCATION: Six participating sites in the United States

PHASE OF CARE: Active antitumor treatment
APPLICATIONS: Palliative care

Randomized, double-blind, placebo-controlled, parallel group design

• Modified Oral Mucositis Index
• Clinical examination by calibrated examiners
• Photographs
• Visual Analog Scale
• Pain Affect Faces Scale
• Length of hospital stay
• Days of parental nutrition

No statistically significant differences in Oral Mucositis Index scores. No statistically significant differences in the peak mucositis severity scores. No statistically significant differences in pain ratings, length of hospital stay, or days of total parenteral nutrition. There were no serious adverse events.

There was not a statistically significant benefit to using a misoprostol rinse in deterring the development or the severity of oral mucositis in patients undergoing autologous stem cell transplant. There was also no decrease in the length of stay or the use of total parenteral nutrition.

Small sample (<100)

Findings not generalizable

Other limitations/*explanation: The patient population was limited to only those cancer patients undergoing autologous stem cell transplant.

This study provides no evidence to support using a misoprostol mouth rinse to prevent the development of mucositis, decrease the severity of mucositis, decrease the length of stay, or decrease the use of total parenteral nutrition in patients undergoing a non-TBI based or non-cisplatin/carboplatin-based conditioning regimen for autologous stem cell transplant.