Pawar, D., Neve, R. S., Kalgane, S., Riva, A., Bombardelli, E., Ronchi, M., et al. (2012). SAMITAL((R)) improves chemo/radiotherapy-induced oral mucositis in patients with head and neck cancer: results of a randomized, placebo-controlled, single-blind Phase II study. Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer.
Investigate the safety and efficacy of SAMITAL in the treatment of oral mucoitis with chemo-radiation therapy.
Patients received either Samital or a matching placebo mouth rinse. Patients were blinded to which treatment they had. Random assignment was not described. Samital is a combination of three botanical drug extracts: vaccinium myrtillus, macleaya cordad, and Echinacea angustifolial root. The formulation is standardized, and forms a gel-like substance when re-constituted. Patients were to use the rinse 4 times daily for a total of 7 weeks. Each rinse was done using 4 aliquots over 30 minutes.
The study was comprised of 17 patients, with a mean age of 52.4 years.
MALES 89%, FEMALES 11%
KEY DISEASE CHARACTERISTICS: All had head and neck cancer and were receiving chemo-radiation. All had oral mucositis ≥ grade 3 on study entry, and 30% had cancer of the tongue.
SITE: Single site
SETTING TYPE: Outpatient
LOCATION: India
PHASE OF CARE: Active antitumor treatment
Single, blind, placebo controlled phase II
None of the control group patients completed the study; most only completed seven days. Patients on SAMITAL showed significant improvement from baseline in mucositis grade from 2.94 ± 0.43 to 2.0 ± 0.35, drinking, eating, sleeping, and speaking (p < 0.05) after day 31. Those in the placebo group did not show significant changes from baseline.
Findings suggest that SAMITAL might have some benefit in management of oral mucositis; however, this study has substantial limitations and does not provide strong evidence.
This study examined use of SAMITAL, a botantical preparation, for its efficacy in management of oral mucositis. Some positive effects are described; however, this study does not provide strong evidence. Further well-designed research in this area may be warranted.