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

Sponsor

Jiarong Chen, MD (Other)

Overall Status

Unknown status

CT.gov ID

NCT04292990

Collaborator

(none)

300

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Nasopharyngeal Carcinoma Head and Neck Cancer Radiation Induced Oral Mucositis	Drug: Fentanyl Drug: Morphine	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Dec 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Pain Intensity Measure [Through chemoradiotherapy completion, 3 weeks]
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.

Secondary Outcome Measures

Incidence of Treatment-Related Adverse Events [Through chemoradiotherapy completion, 3 weeks]
All adverse events were recorded during treatment, and the skin was examined for local reactions during treatment and after removal of fentanyl transdermal patch.
Quality-of-Life composite Index [Through chemoradiotherapy completion, an average of 2 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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