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

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.

Study Overview

• Status: Unknown
• Conditions: Pain; Head and Neck Cancer; Nasopharyngeal Carcinoma; Radiation Induced Oral Mucositis
• Intervention / Treatment: Drug: Fentanyl; Drug: Morphine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 4

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fentanyl; Intervention: Drug: Fentanyl Transdermal Patch	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.; Other Names: Duragesic
Active Comparator: Morphine; Intervention: Drug: Morphine Controlled-Release Tablets	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.; Other Names: MeiShi KangDing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity Measure	Self reported pain intensity once a day according to the numeric rating scale (NRS), with 0-10(0=no pain, 10=pain as bad as can be). The higher scores indicate worse pain.	Through chemoradiotherapy completion, 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Related Adverse Events	All adverse events were recorded during treatment, and the skin was examined for local reactions during treatment and after removal of fentanyl transdermal patch.	Through chemoradiotherapy completion, 3 weeks
Quality-of-Life composite Index	Quality-of-Life was assessed using Karnofsky performance status (KPS) standards of the Union for International Cancer Control and SPAASMS (Score for pain, Physical activity levels, Additional pain medication, Additional physician/emergency room visits, Sleep, Mood, and Side effects) scores before and after 3 days of treatment. The higher KPS scores(0-100) of patients indicate better quality of life, but the higher SPAASMS scores(0-31) mean worse outcome.	Through chemoradiotherapy completion, an average of 2 weeks

Collaborators and Investigators

• Sponsor: Jiarong Chen, MD
• Investigators: Principal Investigator: Jiarong Chen, PhD, Affiliated Jiangmen Hospital of Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: March 1, 2020
• First Submitted That Met QC Criteria: March 1, 2020
• First Posted (Actual): March 3, 2020

Study Record Updates

• Last Update Posted (Actual): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 28, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Diseases; Gastroenteritis; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases; Nasopharyngeal Carcinoma; Nasopharyngeal Neoplasms; Mucositis; Stomatitis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl; Morphine
• Other Study ID Numbers: JM0019001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No