Aoyama, T., Nishikawa, K., Takiguchi, N., Tanabe, K., Imano, M., Fukushima, R., . . . Tsuburaya, A. (2014). Double-blind, placebo-controlled, randomized phase II study of TJ-14 (hangeshashinto) for gastric cancer chemotherapy-induced oral mucositis. Cancer Chemotherapy & Pharmacology, 73, 1047–1054.

DOI Link

Study Purpose

To study the safety and efficacy of TJ-14 in preventing or treating chemotherapy-induced mucositis versus a placebo in patients with gastric cancer

Intervention Characteristics/Basic Study Process

Patients who identified a Common Terminology Criteria for Adverse Events (CTCAE version 4) grade 1 or greater mucositis were randomized on a one-to-one ratio and stratified according to age, chemotherapy regimen, institution, and previous treatment for oral mucositis. Participants received either TJ-14 or a placebo beginning with their next cycle of chemotherapy. The placebo was prepared to mimic the intervention. TJ-14 and the placebo were given three times per day. Patients were instructed to dissolve 2.5 g (total daily dose 7.5 g) of either TJ-14 or the placebo in 50 mL of regular drinking water and to rinse the oral cavity for 10 seconds. Treatment began on the first day of the protocol treatment, continued till the final day, and was administered as much as possible for one course of treatment. No other mouthwash prophylactic interventions for oral mucositis were allowed during the trial period. Assessments took place during the screening cycle from the beginning of the protocol treatment or the appearance of mucositis until all symptoms disappeared.

Sample Characteristics

  • N = 91
  • AVERAGE AGE = 68 years
  • MALES: 62.2% (TJ-14); 60.9% (placebo), FEMALES: 37.8% (TJ-14); 39.1% (placebo)
  • KEY DISEASE CHARACTERISTICS: Patients with gastric cancer who developed an oral mucositis score > 1 on the CTCAE scale during the screening cycle of chemotherapy.
  • OTHER KEY SAMPLE CHARACTERISTICS: None

Setting

  • SITE: Multi-institutional facilities           
  • SETTING TYPE: Cancer center
  • LOCATION: Japan

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active treatment
  • APPLICATIONS: Elder care, palliative care 

Study Design

Randomized, double-blinded, controlled, phase II trial

Measurement Instruments/Methods

  • The National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0
  • Time to resolution of mucositis was defined by the authors as the time from the initiation of the protocol treatment or the first day of mucositis to the day when the patient was symptom-free.
  • Patients self-reported the ability to eat solid foods.
  • Physical examinations, laboratory evaluations, and the reporting of adverse events were used to evaluate safety.

Results

In this study, 40% of patients in the intervention group and 41.3% of patients in the placebo group experienced ≥ grade 2 oral mucositis, and there was no difference between the groups (p = .588). In addition, there was no difference between the two groups concerning the duration of oral mucositis (p = .937).

Conclusions

This study did not demonstrate any beneficial effects of TJ-14 in reducing the incidence of chemotherapy-induced oral mucositis.

Limitations

  • Small sample (< 100)
  • Other limitations/explanation: It is possible that dose reductions in chemotherapy affected the duration of the treatment instead of the standard treatment, which postpones chemotherapy because of mucositis.

Nursing Implications

No prophylactic or treatment-related benefits of TH-14 were evident in this study regardless of the grade of chemotherapy-induced oral mucositis. Nurses should consider other interventions for the prevention and treatment of oral mucositis.