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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04292990
Recruitment Status : Not yet recruiting
First Posted : March 3, 2020
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Jiarong Chen, MD, Jiangmen Central Hospital

Tracking Information
First Submitted Date  ICMJE March 1, 2020
First Posted Date  ICMJE March 3, 2020
Last Update Posted Date July 29, 2020
Estimated Study Start Date  ICMJE December 2020
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 1, 2020)
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)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2020)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2020)
  • 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 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Transdermal Fentanyl and Morphine for Oral Mucositis Pain in Nasopharyngeal Cancer Patients
Official Title  ICMJE A Comparison of Oral Controlled-release Morphine With Transdermal Fentanyl in Nasopharyngeal Cancer Patients With Moderate or Severe Oral Mucositis Pain Induced by Chemoradiotherapy
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pain
  • Nasopharyngeal Carcinoma
  • Head and Neck Cancer
  • Radiation Induced Oral Mucositis
Intervention  ICMJE
  • 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 Name: Duragesic
  • 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 Name: MeiShi KangDing
Study Arms  ICMJE
  • Experimental: Fentanyl
    Intervention: Drug: Fentanyl Transdermal Patch
    Intervention: Drug: Fentanyl
  • Active Comparator: Morphine
    Intervention: Drug: Morphine Controlled-Release Tablets
    Intervention: Drug: Morphine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 1, 2020)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jiarong Chen, PhD 86-0750-3399003 garwingchan@163.com
Contact: Yanghao Ruan ruanyanghao@126.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04292990
Other Study ID Numbers  ICMJE JM0019001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jiarong Chen, MD, Jiangmen Central Hospital
Study Sponsor  ICMJE Jiarong Chen, MD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jiarong Chen, PhD Affiliated Jiangmen Hospital of Sun Yat-Sen University
PRS Account Jiangmen Central Hospital
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP