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

NCT ID: NCT04292990

Last Updated: 2020-07-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-31
• Study Completion Date: 2021-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fentanyl

Intervention: Drug: Fentanyl Transdermal Patch

Group Type: EXPERIMENTAL

Fentanyl

Intervention Type: DRUG

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.

Morphine

Intervention: Drug: Morphine Controlled-Release Tablets

Group Type: ACTIVE_COMPARATOR

Morphine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Duragesic; MeiShi KangDing

Eligibility 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiarong Chen, MD

OTHER

Sponsor Role: lead

Responsible Party

Jiarong Chen, MD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jiarong Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

Affiliated Jiangmen Hospital of Sun Yat-Sen University

Central Contacts

Jiarong Chen, PhD

Role: CONTACT

garwingchan@163.com

86-0750-3399003

Yanghao Ruan

Role: CONTACT

ruanyanghao@126.com

Other Identifiers

JM0019001

Identifier Type: -

Identifier Source: org_study_id