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.

DOI Link

Study Purpose

Investigate the safety and efficacy of SAMITAL in the treatment of oral mucoitis with chemo-radiation therapy.

Intervention Characteristics/Basic Study Process

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.

Sample Characteristics

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.
 

Setting

SITE: Single site

SETTING TYPE: Outpatient

LOCATION: India

 

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Single, blind, placebo controlled phase II

Measurement Instruments/Methods

  • Investigator modified WHO mucositis scale
  • Daily oral mucositis questionnaire
  • VAS for oral pain
     

Results

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.

Conclusions

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.

Limitations

  • Small sample (<30)
  • Risk of bias (no blinding)
  • Unintended interventions or applicable interventions not described that would influence results*
  • Measurement/methods were not well described.  
  • Measurement validity/reliability questionable*
  • Subject withdrawals ≥10%
  • Other limitations/*explanation: There was no discussion of analgesics used in the analysis. Very high number of dropouts, and patients lost to followup. The lack of most control patients beyond week 2 makes any differences seen between the controls and experimental group highly suspect. Revised WHO scale has unknown reliability etc. It is not stated that group assignment was actually random, and though patients were blinded to the treatment, evaluators were not.

Nursing Implications

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.