Sorensen, J.B., Skovsgaard, T., Bork, E., Damstrup, L., & Ingeberg, S. (2008). Double-blind, placebo-controlled, randomized study of chlorhexidine prophylaxis for 5-fluorouracil–based chemotherapy-induced oral mucositis with nonblinded randomized comparison to oral cooling (cryotherapy) in gastrointestinal malignancies. Cancer, 112(7), 1600–1606.

To evaluate chlorhexadine prophylaxis for flouruoracil- (5-FU-) based chemotherapy versus normal saline or cryotherapy

The study involved three arms. Arm A received chlorhexidine mouth rinse three times per day for three weeks (n = 70), Arm B received normal saline placebo (n = 64), and Arm C received cryotherapy with crushed ice for 45 minutes during chemotherapy (n = 63).

• The study reported on 225 randomized patients, 206 of which were evaluable.
• All patients had gastrointestinal cancers.

The study was conducted from 2001–2005.

This was a double-blind, placebo-controlled, randomized study, powered for 225 patients (75 in each arm).

The National Cancer Institute (NCI) Common Toxicity Criteria (CTC)  for oral mucositis was used.

Mucositis grade 3–4 occurred more frequently in arm B (33%) than in arm A (13%) (p < 0.01) and arm C (11%) p > 0.005). Duration was significantly longer in arm B than arm A (p = 0.035) and arm C (p = 0.003).