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

• Status: Not yet recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiarong Chen, MD
• Treatments: Fentanyl; Morphine

Criteria

Inclusion Criteria:

• Patients were pathologically newly diagnosed with nasopharyngeal carcinoma and had no previous history of other tumors

• According to the treatment strategies of doctors, patients need to receive radiotherapy with or without chemotherapy (for example, neoadjuvant chemotherapy, concurrent chemotherapy, adjuvant chemotherapy) or targeted therapy

• Never use a opioid before treatment

• Hematology: WBC≥4.0×109/L, ANC≥1.5×109/L, PLT≥100×109/L,Hb≥90g/L.

• Participants with the ability to assess the pain level

• Willingness to return to enrolling institution for follow-up

Exclusion Criteria:

• Patients do not conform to the inclusion criteria

• Known allergy to fentanyl, morphine, or any known component of the drug formulation

• Refuse to use of opioid drugs

• Nasopharyngeal patients with mental illness

• Current untreated or unresolved oral candidiasis or oral HSV infection

• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

• Pregnant or Nursing women

• Men or women of childbearing potential who are unwilling to employ adequate contraception

• Other contraindications or unsuitable conditions for radiotherapy