Ghalayani, P., Emami, H., Pakravan, F., & Nasr Isfahani, M. (2014). Comparison of triamcinolone acetonide mucoadhesive film with licorice mucoadhesive film on radiotherapy-induced oral mucositis: A randomized double-blinded clinical trial. Asia-Pacific Journal of Clinical Oncology. Advance online publication.

DOI Link

Study Purpose

To determine whether improved pain control and/or ulcer management of oral mucositis in patients with head and neck cancer receiving postoperative radiation therapy can be achieved with licorice mucoadhesive film or triamcinolone acetonide mucoadhesive film

Intervention Characteristics/Basic Study Process

When patients reached a World Health Organization (WHO) grade 2 or 3 mucositis rating, they were randomized according to a balanced block randomization to receive either triamcinolone (T) (.5 mg triamcinolone acetonide in film) or licorice (L) (.18 mg polyphenols as pyrogallol extracted from licorice root) in addition to the standard of care. The standard of care included frequent mouth rinses using boiled water, regular brushing and flossing, scaling, and the removal of plaque and tartar during radiation therapy. The films were applied to the upper lip four times per day. The intervention continued for four weeks or until the cessation of mucositis. The use of analgesics was not permitted before or during the study. Two investigators rated the severity of the mucositis, and data were collected on a weekly basis. Compliance was measured by counting unused films.

Sample Characteristics

  • N = 60  
  • AVERAGE AGE = 57.93 years
  • MALES: 60% (T group); 63.3% (L group), FEMALES: 40% (T group); 36.7% (L group)
  • KEY DISEASE CHARACTERISTICS: This study included patients with head and neck cancer (documented histologically) undergoing radiation therapy with grades 2 and 3 oral mucositis as determined by the WHO scale.
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients were older than 18 years. The ability to continue throughout the entire study was required. The study included men and nonpregnant women. The study excluded patients undergoing chemotherapy and immunotherapy or taking investigational drugs. The study excluded patients with a significant history of drug or alcohol abuse and pregnant women.

Setting

  • SITE: Single-site    
  • SETTING TYPE: Inpatient    
  • LOCATION: Isfahan, Iran

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Double-blinded, prospective, randomized, controlled trial

Measurement Instruments/Methods

  • World Health Organization (WHO) mucositis scale
  • Data forms
  • Visual Analog Scale (VAS)

Results

There was a significant difference in the mean value of the mucositis scores for the T and L interventions when compared to the control group (p < .05) although there was no difference between the two intervention groups. No statistically significant difference was achieved (p > .05) between interventions in reducing pain during radiation therapy. However, each was statistically significant (p < .05) in reducing pain during radiation therapy when compared to the standard of care alone. A slight additional reduction in pain was noted in the L group, but it was not significant.

Conclusions

Both triamcinolone acetonide mucoadhesive film and licorice mucoadhesive film reduced the mean mucositis score and the pain associated with mucositis during radiation therapy when compared to the group that only received standard of care. However, there was no significant difference between the two interventions for mucositis scores or pain scores when compared to each other.

Limitations

  • Small sample (< 100)
  • Findings not generalizable
  • Other limitations/explanation: State-run cancer center; convenience sampling; pre-existing oral complications

Nursing Implications

Although there is not enough evidence to recommended the use of this intervention, this study is a good starting point for nurse research to continue working toward finding additional, better ways to treat and prevent oral mucositis and its complications in patients undergoing cancer treatment.