Intestinal trefoil factor is a peptide that is found in mucosal goblet cells and plays a role in mucosal defense and repair. Topical use of recombinant human intestinal trefoil factor was evaluated for its effect in patients with cancer for the prevention and management of mucositis.
Peterson, D.E., Barker, N.P., Akhmadullina, L.I., Rodionova, I., Sherman, N.Z., Davidenko, I.S., et al. (2009). Phase II, randomized, double-blind, placebo-controlled study of recombinant human intestinal trefoil factor oral spray for prevention of oral mucositis in patients with colorectal cancer who are receiving fluorouracil-based chemotherapy. Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology, 27(26), 4333–4338.
To evaluate the safety and efficacy of human intestinal trefoil factor (rh/TF) oral spray for the treatment and prevention of chemotherapy-induced oral mucositis.
Patients who had at least grade 2 oral mucositis after the first course of chemotherapy were randomized to receive placebo spray, low-dose rh/TF (10 mg/ml) spray, or high-dose rh/TF (80 mg/ml) spray. Patients had to fully recover from the mucositis prior to study entry. Patients were instructed to administer three puffs to the oral mucosa eight times daily for 14 days, beginning on the first day of the second chemotherapy cycle. Patients were to refrain from oral intake for 15 minutes after dosing.
Randomized double-blind placebo-controlled trial
World Health Organization grading system for oral mucositis
Topical administration of rh/TF was safe and effective in ameliorating symptoms of chemotherapy-induced oral mucositis.
The study suggests that rh/TF is a promising approach for the prevention and management of oral mucositis. Its ease of use and safety profile makes rh/TF a practical treatment. Authors did not discuss cost, which may be a consideration. Further study in other patient groups is warranted.