Prophylaxis of recurrent chemotherapy-induced oral mucositis: A phase II multicenter, randomized, placebo-controlled trial of recombinant human intestinal trefoil factor (rhITF)

Carolyn Vachani, RN, MSN, AOCN
The Abramson Cancer Center of the University of Pennsylvania
Last Modified: June 23, 2008

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Prophylaxis of recurrent chemotherapy-induced oral mucositis: A phase II multicenter, randomized, placebo-controlled trial of recombinant human intestinal trefoil factor (rhITF)

Oral mucositis is a common, debilitating symptom affecting many patients on high-dose chemotherapy. It is an inflammation of the mucous membranes of the mouth, and can often range from erythema and sores to severe ulcerations. It can be quite painful, and often prevents patients from eating, drinking, or talking for long periods of time.

Intestinal Trefoil Factor (ITF), is a protein found mostly on mucosal surfaces throughout the gastrointestinal tract. ITF has been shown to promote mucosal protection, repair, and restitution. Therefore, it is hypothesized that therapy with recombinant human ITF (rhITF) can alleviate damage to the mucosa of the oral cavity and lessen the effects of oral mucositis. This study randomly assigned 99 patients receiving 5-FU chemotherapy, who had mucositis with their first cycle of chemotherapy, to receive placebo, low dose ITF, or high dose ITF (in the form of an oral spray).

The results:

Placebo

Low Dose

High Dose

# of patients with grade 2 or greater mucositis

16/33

48.5%

3/33

9.1%

4/33

12.1%

No serious side effects were reported. These results are quite promising, but this is a very small study and further study must be done on larger groups. It will also be interesting to study this drug in other patient populations, particularly stem cell transplants, where oral mucositis is quite severe.