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

NCT04292990 | Unknown Phase 4

• 1 other identifier: JM0019001
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain; Nasopharyngeal Carcinoma; Head and Neck Cancer; Radiation Induced Oral Mucositis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of Treatment-Related Adverse Events

  Through chemoradiotherapy completion, 3 weeks

• Quality-of-Life composite Index

  Through chemoradiotherapy completion, an average of 2 weeks

Study Arms (2)

Fentanyl

EXPERIMENTAL

Intervention: Drug: Fentanyl Transdermal Patch

Drug: Fentanyl

Morphine

ACTIVE COMPARATOR

Intervention: Drug: Morphine Controlled-Release Tablets

Drug: Morphine

Interventions

Fentanyl DRUG

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.

Also known as: Duragesic

Fentanyl

Morphine DRUG

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.

Also known as: MeiShi KangDing

Morphine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiarong Chen, MD: lead

MeSH Terms

Conditions

Pain; Nasopharyngeal Carcinoma; Head and Neck Neoplasms

Interventions

Fentanyl; Morphine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Jiarong Chen, PhD

  Affiliated Jiangmen Hospital of Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiarong Chen, PhD

CONTACT

86-0750-3399003; garwingchan@163.com

Yanghao Ruan

CONTACT

ruanyanghao@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 1, 2020
• First Posted: March 3, 2020
• Study Start: December 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 29, 2020

Record last verified: 2020-07