Comparison of Transdermal Fentanyl and Morphine for Oral Mucositis Pain in Nasopharyngeal Cancer Patients
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|ClinicalTrials.gov Identifier: NCT04292990|
Recruitment Status : Not yet recruiting
First Posted : March 3, 2020
Last Update Posted : July 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pain Nasopharyngeal Carcinoma Head and Neck Cancer Radiation Induced Oral Mucositis||Drug: Fentanyl Drug: Morphine||Phase 4|
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 (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||December 2020|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Intervention: Drug: Fentanyl Transdermal Patch
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 Name: Duragesic
Active Comparator: Morphine
Intervention: Drug: Morphine Controlled-Release Tablets
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 Name: MeiShi KangDing
- Pain Intensity Measure [ Time Frame: 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.
- Incidence of Treatment-Related Adverse Events [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04292990
|Contact: Jiarong Chen, PhDfirstname.lastname@example.org|
|Contact: Yanghao Ruanemail@example.com|
|Principal Investigator:||Jiarong Chen, PhD||Affiliated Jiangmen Hospital of Sun Yat-Sen University|