title: Colchicine mouth washings to improve oral mucositis in patients with hematological malignancies: a clinical trial.
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; 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.
authors.affiliation: Clinical Oncology and Hematology Department, Clínica de Oncología Astorga and Unidad de Trasplante de Médula Osea Clínica SOMA, Medellín, Colombia.
authors.forename: Andrés Avila
authors.initials: AA
authors.lastname: Garavito
authors.forename: Andrés Felipe
authors.initials: AF
authors.lastname: Cardona
authors.forename: Ludovic
authors.initials: L
authors.lastname: Reveiz
authors.forename: Edgar
authors.initials: E
authors.lastname: Ospina
authors.forename: Andrés
authors.initials: A
authors.lastname: Yepes
authors.forename: Vannesa
authors.initials: V
authors.lastname: Ospina
mesh_terms: 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
chemical_list: D009067:Mouthwashes; D020011:Protective Agents; D003078:Colchicine