Awidi, A., Homsi, U., Kakail, R.I., Mubarak, A., Hassan, A., Kelta, M., … El-Aloosy, A.S. (2001). Double-blind, placebo-controlled cross-over study of oral pilocarpine for the prevention of chemotherapy-induced oral mucositis in adult patients with cancer. European Journal of Cancer, 37, 2010–2014.doi: 10.1016/S0959-8049(01)00189-7
Patients were given oral pilocarpine (OP) or placebo, 5 mg tablet blister pack, 1 hour before chemotherapy administration and 1 tablet every eight hours for seven days. After two weeks, the alternate arm was given with the same chemotherapy. Normal saline mouthwash only was permitted. No granulocyte macrophage colony-stimulating factor (GM-CSF), granulocyte colony-stimulating factor (G-CSF), or dose modifications were allowed. Empty blister packs were returned and remaining tablets were counted.
The study was conducted from February to December of 2000.
This study had a randomized, double-blind, placebo-controlled, cross-over design.
Patients were seen daily on days 7–11 post-chemotherapy. Patients were checked for signs and symptoms of mucositis.
Mucositis was scored using three measures.
A. Method developed by J.P. Donnelly and colleagues, 1992
B. The World Health Organization (WHO) mucositis score
C. Report of mild, moderate, or severe
Peak A, B, and C scores and presence of mucositis were recorded.
Results for 32 patients receiving 82 courses of chemotherapy were included; six patients were excluded from the results because of protocol violations.
OP was effective in preventing and reducing the severity of mucositis (p < 0.005 and < 0.001).
Placebo versus OP scores were as follows.
A. 52 versus 11 (p < 0.001)
B. 25 versus 6 (p < 0.001)
C. 23 versus 6 (p < 0.001)
No course with mucositis: 20 versus 6 (p < 0.005)
Side effects included tachycardia and palpitations in one patient.
The study showed that oral pilocarpine was associated with lower rates and severity of oral mucositis.
The sample size was small.