Clinical trial NCT04292990: Comparison of Transdermal Fentanyl and Morphine for Oral Mucositis Pain in Nasopharyngeal Cancer Patients
Official title: A Comparison of Oral Controlled-release Morphine With Transdermal Fentanyl in Nasopharyngeal Cancer Patients With Moderate or Severe Oral Mucositis Pain Induced by Chemoradiotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain
Nasopharyngeal Carcinoma
Head and Neck Cancer
Radiation Induced Oral Mucositis
Lead sponsor: Jiangmen Central Hospital
Sponsor class: OTHER
First posted: 2020-03-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

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

Primary outcomes:
measure: Pain Intensity Measure
timeFrame: Through chemoradiotherapy completion, 3 weeks
Secondary outcomes:
measure: Incidence of Treatment-Related Adverse Events
timeFrame: Through chemoradiotherapy completion, 3 weeks
measure: Quality-of-Life composite Index
timeFrame: Through chemoradiotherapy completion, an average of 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Affiliated Jiangmen Hospital of Sun Yat-Sen University
name: Jiarong Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References: