Veness, M.J., Foroudi, F., Gebski, V., Timms, I., Sathiyaseelan, Y., Cakir, B., et al. (2006). Use of topical misoprostol to reduce radiation-induced mucositis: Results of a randomized, double-blind, placebo-controlled trial. Australasian Radiology, 50(5), 468–474.

200 mcg of misoprostol or placebo was dissolved in 15 ml of water. Patients swished in oral cavity for two minutes, then swallowed. Patients were advised to gargle before swallowing.

The study was comprised of 83 patients with squamous cell carcinoma of the head and neck, older than 18 with a total radiation dose higher than 50 Gy.
Misoprostol arm: n = 42
Placebo arm: n = 41
 

1999–2002

Double-blind, placebo-controlled, randomized trial

Extent of RTOG grade 3 mucositis (incidence and duration).

Secondary endpoints were time to development of mucositis, extent of grade 2 mucositis, patient weight, general well-being using VAS, and oropharyngeal or oral soreness.

RTOG, VAS
 

No significant differences were found for endpoints. More patients in the misoprostol arm reported increased levels of oral or oropharyngeal soreness.

Did not accrue adequate patients according to statistical analysis.

12% patient withdrawals