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Colchicine mouth washings to improve oral mucositis in patients with hematological malignancies: A clinical trial

Published online by Cambridge University Press:  13 November 2008

Andrés Ávila Garavito
Affiliation:
Clinical Oncology and Hematology Department, Clínica de Oncología Astorga and Unidad de Trasplante de Médula Ósea Clínica SOMA, Medellín, Colombia
Andrés Felipe Cardona*
Affiliation:
Clinical Oncology Department, Instituto Nacional de Cancerología, Bogotá D.C., Colombia Cochrane Colombian Group, Bogotá, D.C., Colombia
Ludovic Reveiz
Affiliation:
Cochrane Colombian Group, Bogotá, D.C., Colombia
Edgar Ospina
Affiliation:
Cochrane Colombian Group, Bogotá, D.C., Colombia
Andrés Yepes
Affiliation:
Clinical Oncology Department, Instituto Nacional de Cancerología, Bogotá D.C., Colombia
Vannesa Ospina
Affiliation:
Clinical Oncology Department, Instituto Nacional de Cancerología, Bogotá D.C., Colombia
*
Address correspondence and reprint requests to: Andrés Felipe Cardona, Clinical Oncology Department, Instituto Nacional de Cancerología, Bogotá, D.C., Colombia. E-mail: [email protected]

Abstract

Objective:

Oral mucositis (OM) is a frequently encountered problem as a complication of cancer treatment. We investigated whether daily washings with colchicine solution improved mucositis in patients with hematological malignancies undergoing chemotherapy.

Methods:

This study was a one-arm, nonrandomized clinical trial that used a historical control group. Patients were included in the study from the first day of mucositis and followed up until discharge. Patients received 2 mg colchicine mouthwashes daily for 5 days or saline solution. OM was assessed once daily until symptom resolution, using the WHO grading scale of 0–4 and a visual analogue scale. We determined that at least 40 patients in the colchicine group would be needed to detect a 20% difference in the duration of OM between Groups A and B, with a 95% confidence level and a power of 80%.

Results:

82 patients were included in the final analysis, 40 in the colchicine group and 42 in the control group. Median duration of OM was significantly different among groups; 9days (range 1–17days) for the control group versus 6days (range 3–13days) for those exposed to colchicine mouthwash (p = .028). The median days of regression of mucosal lesions were significantly different (p = .047) among the control group (7 days [range 3–20]) compared to the colchicine group (4 days [range 2–14]).

Significance of results:

Although our findings suggest that colchicine mouthwash is helpful in reducing the severity and duration of chemotherapy-induced OM, randomized trials are needed to confirm these results.

Type
Original Articles
Copyright
Copyright © Cambridge University Press 2008

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