Garavito, A.A., Cardona, A.F., Reveiz, L., Ospina, E., Yepes, A., & Ospina, V. (2008). Colchicine mouth washings to improve oral mucositis in patients with hematological malignancies: A clinical trial. Palliative & Supportive Care, 6, 371–376.

DOI Link

Study Purpose

To evaluate the use of colchicine solution in the treatment of mucositis in patients with hematologic malignancies undergoing chemotherapy

Intervention Characteristics/Basic Study Process

Group A (control) used a 9% sodium chloride (NaCl) and water solution. Group B used a colchicine solution of 2 mg dissolved in 500 cc of sterile water starting the first day of symptoms of oral mucositis until the fifth day of the disease (inflammatory phase). Following the fifth day, patients in group B received same as group A. The solution for both groups was prepared fresh every morning. Both groups gargled for two minutes, four times a day while being supervised by a researcher. Twice a day, patients brushed with a soft toothbrush, if possible. During the study, patients were allowed concomitant interventions for oral mucositis (OM), such as systemic antibiotics, antimycotics, antivirials, antiemetics, analgesics, and granulocyte colony-stimulating factor (G-CSF) support. Cryotherapy and other oral mouthwashes were not permitted.

Sample Characteristics

  • The study reported on 82 patients, with a median age of 42 years in group A and 50 years in group B.
  • The sample had 37 females and 45 males.
  • Patients had OM and had been diagnosed with lymphoma or acute leukemia treated with high-risk chemotherapy.

Setting

The study was conducted in an inpatient cancer center in Bogota, Columbia.

Study Design

This study used a single arm, nonrandomized, sequentially enrolled, historical control group.

Measurement Instruments/Methods

  • Oral assessments were done once a day until resolution using the World Health Organization (WHO) Oral Toxicity Scale.
  • Oral pain was evaluated twice a day using a visual analog scale (VAS).
  • Tolerability of mouthwash was evaluated by the patient once daily using a VAS.
  • Maximum daily body temperature was recorded until OM was resolved.
  • The characteristics, severity, and duration of OM, length of inpatient hospitalization, severity of OM-related pain, days of opioid consumption, tolerability of mouthwashes, change in oral pH (using pH meter), and occurrence of infection were evaluated using the Mann-Whitney test and Fisher’s exact test.
  • Statistical analyses were performed using the SPSS 12.0 Statistical package.

Results

  • Patients in the treatment group experienced significantly lower median duration of OM (6 days versus 9 days) (p = 0.028).
  • Patients in the treatment group experienced significantly fewer median days to healing of mucosal lesions (4 days versus 7 days) (p = 0.047).
  • No differences were found in the number of days of hospitalizations, variations in weight, voice characteristics, salivation production, mucosal pH, and frequency and volume of oral mucosal bleeding.
  • Oral pain assessment was similar, and no significant differences were found in opioid consumption.
  • No differences were found in tolerability of mouthwashes.
  • No serious side effects were reported with colchicine mouthwash.
  • No differences were found in incidence of febrile neutropenia.

Conclusions

Colchicine mouthwash may be helpful in reducing the severity and duration of chemotherapy-induced OM.

Limitations

  • The sample size was small.
  • The study was not randomized or blinded.
  • Patients were able to use multiple other interventions for mucositis. Use of these interventions was not reported or discussed, so one cannot tell which interventions actually had an effect.

Nursing Implications

Further studies are needed to confirm results. This was done in an inpatient setting under direct supervision; these findings may not be applicable in other situations.