NCT04292990

Comparison of Transdermal Fentanyl and Morphine for Oral Mucositis Pain in Nasopharyngeal Cancer Patients

A Comparison of Oral Controlled-release Morphine With Transdermal Fentanyl in Nasopharyngeal Cancer Patients With Moderate or Severe Oral Mucositis Pain Induced by Chemoradiotherapy

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Jiarong Chen, MD · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to explore the significance of analgesic treatment for radiation-induced oral mucositis pain in patients with nasopharyngeal carcinoma during radiotherapy, and to compare the analgesic effect of morphine controlled-release tablets with that of fentanyl transdermal patch. Half of participants will receive morphine controlled-release tablets,while the other half will receive fentanyl transdermal patch.

Detailed description

Morphine controlled-release tablets and fentanyl transdermal patch each relieve radiation-induced oral mucositis pain in patients with nasopharyngeal carcinoma. But they do so by different mechanisms and in different effects. Morphine is a classic strong analgesic, which has been widely used in patients with advanced cancer pain. It has achieved satisfactory results in pain control, sleep improvement and quality of life. Oral morphine has been regarded as the standard treatment for moderate and severe cancer pain. Fentanyl transdermal patch is a system device for transdermal delivery of drugs. It is compressed on a film containing fentanyl memory. The film can continuously release fentanyl into the blood circulation and maintain stable for more than 72 hours. It is not affected by gastrointestinal PH or food, and it has no hepatic frst-pass effect, with a bioavailability of up to 92%. This study will test the efficacy and safety of morphine controlled-release tablets compared to fentanyl transdermal patch in the treatment of pain in patients with radiation-induced oral mucositis.

Conditions

• Pain
• Nasopharyngeal Carcinoma
• Head and Neck Cancer
• Radiation Induced Oral Mucositis

Interventions

Type	Name	Description
DRUG	Fentanyl	Patch releasing drug at the rate of 25 µg/hour, increasing by 25 µg/hour increments to maintain the NRS score≤3 after the frst 24 hours according to no change in pain control. The maximum dose allowed in this study is 300 µg/hour.
DRUG	Morphine	Tablets taken orally, twice daily, morning \& evening with preferably 12 hours (not less than 6 hours) between doses. Titration phase: starting at 30 mg, increasing at a minimum of 3 days intervals by 20 mg, with a maximum dose of 100 mg. Maintenance phase: continuing on dose level established in titration phase.

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2020-03-03
• Last updated: 2020-07-29