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

Primary Purpose

Pain, Nasopharyngeal Carcinoma, Head and Neck Cancer

Status

Unknown status

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Fentanyl

Morphine

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fentanyl

Morphine

Arm Description

Intervention: Drug: Fentanyl Transdermal Patch

Intervention: Drug: Morphine Controlled-Release Tablets

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT04292990

First Posted

March 1, 2020

Last Updated

July 28, 2020

Sponsor

Jiarong Chen, MD

1. Study Identification

Unique Protocol Identification Number

NCT04292990

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Unknown status

Study Start Date

December 2020 (Anticipated)

Primary Completion Date

December 2021 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jiarong Chen, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Fentanyl

Arm Type

Experimental

Arm Description

Intervention: Drug: Fentanyl Transdermal Patch

Arm Title

Morphine

Arm Type

Active Comparator

Arm Description

Intervention: Drug: Morphine Controlled-Release Tablets

Intervention Type

Drug

Intervention Name(s)

Fentanyl

Other Intervention Name(s)

Duragesic

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Morphine

Other Intervention Name(s)

MeiShi KangDing

Intervention Description

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.

Primary Outcome Measure Information:

Title

Pain Intensity Measure

Description

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.

Time Frame

Through chemoradiotherapy completion, 3 weeks

Secondary Outcome Measure Information:

Title

Incidence of Treatment-Related Adverse Events

Description

All adverse events were recorded during treatment, and the skin was examined for local reactions during treatment and after removal of fentanyl transdermal patch.

Time Frame

Through chemoradiotherapy completion, 3 weeks

Title

Quality-of-Life composite Index

Description

Time Frame

Through chemoradiotherapy completion, an average of 2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jiarong Chen, PhD

Phone

86-0750-3399003

garwingchan@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Yanghao Ruan

ruanyanghao@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jiarong Chen, PhD

Organizational Affiliation

Affiliated Jiangmen Hospital of Sun Yat-Sen University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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