Bertoglio, J.C., Calderon, S., Lesina, B., Pilleux, L., Morazzoni, P., Riva, A., . . . Petrangolini, G. (2013). Effect of SAMITAL^® in the treatment of chemotherapy-induced mucositis in adult oncohematological patients. Future Oncology, 9, 1727–1732. 

To evaluate the efficacy and safety of SAMITAL in reducing mucositis in patients undergoing treatment for hematologic malignancies

Patients used SAMITAL mouth rinse three to four times daily and held it in the mouth for one minute.

• N = 25  
• AGE: 18–84 years (Note: in the abstract, age was 18–74 years)
• MALES: 19 (76%), FEMALES: 6 (24%)
• KEY DISEASE CHARACTERISTICS: Adult patients with cancer undergoing treatment for hematologic malignancies

• SITE: Single site  
• SETTING TYPE: Inpatient   
• LOCATION: Hospital Clinico Regional de Valdivia, Valdivia, Chile

• PHASE OF CARE: Transition phase after active treatment
• APPLICATIONS: Elder care

• Observational, uncontrolled study

• World Health Organization (WHO) mucositis grading scale (variables: stomatitis, dysphagia, gastritis, enteritis, pain, and feeding) performance status of less than 2

The grade of mucositis was reduced from grade 2 to 0–1 in seven patients (25%). It is stated that pain, mucosal erosions, bleeding, and dysphagia were reduced; however, it is unclear how these were measured.

SAMITAL may have some benefit in the prevention and management of oral mucositis.

• Small sample (< 30)
• Risk of bias (no control group)
• Risk of bias (no blinding)  
• Risk of bias (no random assignment)
• Risk of bias(sample characteristics)
• Selective outcomes reporting
• Findings not generalizable
• Other limitations/explanation: Due to the small sample, the researchers performed only descriptive statistics.

The authors suggested performing randomized, placebo-controlled clinical trials to confirm the suitability of SAMITAL for the treatment and prophylaxis of mucositis.