Guo, S.P., Wu, S.G., Zhou, J., Feng, H.X., Li, F.Y., Wu, Y.J., . . . He, Z.Y. (2014). Transdermal fentanyl for pain due to chemoradiotherapy-induced oral mucositis in nasopharyngeal cancer patients: Evaluating efficacy, safety, and improvement in quality of life. Drug Design, Development and Therapy, 8, 497.

To evaluate the safety and efficacy of transdermal fentanyl for oral mucositis pain

Transdermal fentanyl was given at a rate of 25 mcg per hour to patients with pain scores greater than five during treatment and increased by 25 mcg per hour to maintain pain scores less than or equal to three on a numeric rating scale. Study assessments were done on days 1, 4, 7, and 10. Patients rated pain daily.

• N = 78
• MEDIAN AGE = 41 years (range = 31–52 years)
• MALES: 75.6%, FEMALES: 24.4%
• KEY DISEASE CHARACTERISTICS: All participants had nasopharyngeal cancer and were receiving daily radiation therapy of prescribed doses of 70 Gy to the planning target volume. Patients also were receiving chemotherapy of cisplatin with 5-FU or taxol and cisplatin.

• SITE: Single-site
• SETTING TYPE: Outpatient
• LOCATION: China

PHASE OF CARE: Active antitumor treatment

Open-label, observational trial

• Pain numeric rating scale
• Score for pain, Physical activity levels, Additional pain medication, Additional physician/emergency room visits, Sleep, Mood, and Side effects (SPAASMS)

Mean pain scores declined from 7.41 before treatment to 5.54 (SD = 0.86, p < 0.001) on day 1 and 2.82 (SD = 0.68, p < 0.001) on day 10. Sleep quality was improved after treatment (p < 0.001). The most frequent side effect was nausea and vomiting. No patients discontinued treatment.

Transdermal fentanyl was quickly effective in reducing pain from oral mucositis in this patient population. Pain reduction was associated with improved sleep.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Measurement/methods not well described
• Other limitations/explanation: The method of sleep quality measurement was not described. The final doses of fentanyl were not reported.

The findings of this study demonstrated that transdermal fentanyl was effective in reducing oral mucositis-related pain within one day, and pain scores continued to decline during combined radiation and chemotherapy. They also suggested that adequate pain control in this patient population improves sleep quality and other aspects of quality of life.