Colchicine mouth washings to improve oral mucositis in patients with hematological malignancies: a clinical trial.
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; 9 days (range 1-17 days) for the control group versus 6 days (range 3-13 days) 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]).


CONCLUSIONS
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.
Garavito
Andrés Avila
AA
Clinical Oncology and Hematology Department, Clínica de Oncología Astorga and Unidad de Trasplante de Médula Osea Clínica SOMA, Medellín, Colombia.
Cardona
Andrés Felipe
AF
Reveiz
Ludovic
L
Ospina
Edgar
E
Yepes
Andrés
A
Ospina
Vannesa
V
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects; D003078:Colchicine / Q000008:administration & dosage*; D003105:Colombia; D005260:Female; D019337:Hematologic Neoplasms / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009061:Mouth Mucosa / Q000187:drug effects; D009067:Mouthwashes / Q000008:administration & dosage*; D019226:Oral Ulcer / Q000139:chemically induced / Q000517:prevention & control*; D020011:Protective Agents / Q000008:administration & dosage*; D012720:Severity of Illness Index; D013280:Stomatitis / Q000139:chemically induced / Q000517:prevention & control*; D016896:Treatment Outcome
D009067:Mouthwashes; D020011:Protective Agents; D003078:Colchicine