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PCA vs Non-PCA Intravenous Hydromorphone Titration for Severe Cancer Pain

Primary Purpose

Cancer Pain

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Hydromorphone
PCA pump
Sponsored by
Fujian Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer Pain focused on measuring hydromorphone titration

Eligibility Criteria

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

Inclusion Criteria:

  1. With written informed consent signed voluntarily by patients themselves.
  2. Cancer patients aged 18-70 years old.
  3. Patients with cancer pain more than or equal to NRS 7 during previous 24 hours.
  4. Patients who will not be treated with radiotherapy within 7 days prior to randomization and during study.
  5. Patients who need chemotherapy, long term administration of hormone, targeted therapy, or bisphosphonates therapy should undergo a stable anti- tumor therapy prior to randomization.
  6. Patients or his/her caregivers who are able to fill out the questionnaire forms.
  7. Ability to correctly understand and cooperate with medication guidance of doctors and nurses.
  8. Without a history of anaphylaxis of narcotic drugs.
  9. Without psychiatric problems.
  10. ECOG performance status ≤3.
  11. Not participated in another drug clinical trial within one month before inclusion（including hydromorphone）.

Exclusion Criteria:

  1. Patients diagnosed with non-cancer pain or unexplained pain.
  2. Patients suffered with post-op pain.
  3. Patients having paralytic ileus.
  4. Patients who have hypersensitivity to hydromorphone.
  5. There are abnormal lab results, with obvious clinical significance, such as the creatinine ≥ 2 fold of upper limit of normal value, or ALT or AST ≥ 2.5 fold of upper limit of normal value (≥ 5 fold,to the patients with liver metastasis or primary liver cancer), or liver function of Child C grade.
  6. Patients having a incoercible Nausea and vomiting.
  7. Monoamine oxidase inhibitor (MAOI) was administrated two week before randomization.
  8. Patients who are pregnant or lactating,who plans to be pregnant within one month after the trial（including male）.
  9. Patients who are opioid abuse.
  10. Patients who are alcohol abuse.
  11. Patients who are cognitive dysfunction.
  12. Patients having a severe psychotic depression.
  13. Patients with any other medical condition or reason, in that investigator's opinion, makes the patient unable to participate in a clinical trial.

Sites / Locations

  • Rongbo Lin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PCA IV Hydromorphone titration

non-PCA IV Hydromorphone titration

Arm Description

PCA titration using programmable pump: bolus hydromorphone at 0.5mg (for opioid intolerance) or hydromorphone dose equivalent to 10% to 20% of the total opioid taken in the previous 24 hours with a lockout time 15 min (for opioid tolerance) was administered by the patients educated. No basal infusion was set in the pump.Repeated assessment of NRS score with a interval of 15 minutes until stable pain control. Then Repeated assessment of NRS score with a interval of 1 hour. The titration will be done on the patient's request (manipulation by the patient himelf/herself) in 24hrs.

Non-PCA titration administered by a nurse or clinician: Initial hydromorphone doses were same with PCA titration. Repeated assessment of NRS score with a interval of 15 minutes until stable pain control. Then Repeated assessment of NRS score with a interval of 1 hour. The dose of hydromorphone increased by 50%-100% if pain unchanged or increased, or repeat same dose if pain decrease to 4-6. The titration will be done on the patient's request (manipulation by a nurse) in 24hrs.

Outcomes

Primary Outcome Measures

The time of successful titration in 24 hours
The satisfied pain control was defined NRS pain score ≤ 3 at rest in at least 2 consecutive assessment (15 minutes interval). The time needed to successful titration was extended to achieve satisfied pain control again if NRS pain score ≥ 7 after satisfied pain control within 24 hours. The failure of successful titration was defined that satisfied pain control does not achieve within 24 hours.

Secondary Outcome Measures

The percentage of patients titrated successfully within 60 minutes
The percentage of patients who titrated successfully within 60 minutes
The percentage of patients titrated successfully within 24 hours
The percentage of patients who titrated successfully within 24 hours
The mean NRS pain score of 24 hours
The Numerical Rating Scale (NRS) is used to assess the severity of pain. The scale represents pain levels in 0-10 numbers, with 0 indicating no pain and 10 indicating the most severe pain. Ask the patient to choose the number that best represents his or her pain level, or ask the patient to ask: How severe is participant's pain? The health care provider selects the appropriate number based on the patient's description of the pain. 1-3 points indicate mild pain, 4-6 points indicate moderate pain, and 7-10 points indicate severe pain. "The mean NRS pain score of 24 hrs" is defined as the sum of the scores within 24 hours divided by the number of evaluations within 24 hours.
The total dose of hydromorphone titrated from start of titration to TST
The total dose of hydromorphone titrated from start of titration to TST
The total dose of hydromorphone titrated within 24 hrs
The total dose of hydromorphone titrated within 24 hrs
Improvement of patient symptoms
The change from baseline in questionnaire: Chinese version of the Edmonton Symptom Assessment System
Adverse Events
treatment-related Adverse Events:

Full Information

First Posted
December 13, 2017
Last Updated
March 4, 2021
Sponsor
Fujian Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03375515
Brief Title
PCA vs Non-PCA Intravenous Hydromorphone Titration for Severe Cancer Pain
Official Title
Patient Controlled Analgesia (PCA) vs Non-PCA Intravenous Hydromorphone Titration for Severe Cancer Pain: A Prospective, Randomized, Controlled, Multi-center, Phase III Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
September 29, 2018 (Actual)
Primary Completion Date
December 10, 2019 (Actual)
Study Completion Date
January 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujian Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A large number of studies have shown that patients feel more satisfied with hydromorphone in the pain management. and a systematic review found that hydromorphone may be better suited than morphine for titration of acute analgesia. However, current researches on intravenous opioid titration for cancer pain such as hydromorphone are relatively insufficient in China. Therefore, a prospective, multi-center, randomized controlled study is conducted to assess the efficacy and safety of comparing patient-controlled analgesia (PCA) versus non-PCA intravenous hydromorphone titration for severe cancer pain.
Detailed Description
The opioid dose for individual with cancer pain to provide adequate relief of pain with an acceptable degree of side effects is variable. Opioid titration is a process to obtain the tailored dose. Conventional titration is administered by a clinician or nurse. PCA is that patients control cancer pain by self-administration of intravenous opioids using programmable pump. The aim of our study is to evaluate the efficacy of PCA titration versus conventional titration intravenously for severe cancer pain (10-point numerical rating scale, NRS ≥ 7). Injectable Hydromorphone was selected as pharmaceutical analgesics, which works as well as morphine and oxycodone and had similar side effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Pain
Keywords
hydromorphone titration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
214 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PCA IV Hydromorphone titration
Arm Type
Experimental
Arm Description
PCA titration using programmable pump: bolus hydromorphone at 0.5mg (for opioid intolerance) or hydromorphone dose equivalent to 10% to 20% of the total opioid taken in the previous 24 hours with a lockout time 15 min (for opioid tolerance) was administered by the patients educated. No basal infusion was set in the pump.Repeated assessment of NRS score with a interval of 15 minutes until stable pain control. Then Repeated assessment of NRS score with a interval of 1 hour. The titration will be done on the patient's request (manipulation by the patient himelf/herself) in 24hrs.
Arm Title
non-PCA IV Hydromorphone titration
Arm Type
Active Comparator
Arm Description
Non-PCA titration administered by a nurse or clinician: Initial hydromorphone doses were same with PCA titration. Repeated assessment of NRS score with a interval of 15 minutes until stable pain control. Then Repeated assessment of NRS score with a interval of 1 hour. The dose of hydromorphone increased by 50%-100% if pain unchanged or increased, or repeat same dose if pain decrease to 4-6. The titration will be done on the patient's request (manipulation by a nurse) in 24hrs.
Intervention Type
Drug
Intervention Name(s)
Hydromorphone
Intervention Description
For opioid-intolerant patients: continuous infusion of hydromorphone 0 mg per hour, and a demand dose of 0.5 mg with a lockout interval of 15 minutes. For opioid-tolerant patients: basal rate 0 mg per hour, and a demand dose of 10% of the hydromorphone dose equivalent to the total opioid taken in the previous 24 hrs with a lockout interval of 15 minutes.
Intervention Type
Device
Intervention Name(s)
PCA pump
Intervention Description
For opioid-intolerant patients: initial dose 0.5 mg intravenous hydromorphone. For opioid-tolerant patients: intravenous hydromorphone with a initial dose equivalent to 10%(5-15%) of the total opioid taken in the previous 24 hrs.
Primary Outcome Measure Information:
Title
The time of successful titration in 24 hours
Description
The satisfied pain control was defined NRS pain score ≤ 3 at rest in at least 2 consecutive assessment (15 minutes interval). The time needed to successful titration was extended to achieve satisfied pain control again if NRS pain score ≥ 7 after satisfied pain control within 24 hours. The failure of successful titration was defined that satisfied pain control does not achieve within 24 hours.
Time Frame
In 24 hours
Secondary Outcome Measure Information:
Title
The percentage of patients titrated successfully within 60 minutes
Description
The percentage of patients who titrated successfully within 60 minutes
Time Frame
Up to 60 minutes
Title
The percentage of patients titrated successfully within 24 hours
Description
The percentage of patients who titrated successfully within 24 hours
Time Frame
Up to 24 hours
Title
The mean NRS pain score of 24 hours
Description
The Numerical Rating Scale (NRS) is used to assess the severity of pain. The scale represents pain levels in 0-10 numbers, with 0 indicating no pain and 10 indicating the most severe pain. Ask the patient to choose the number that best represents his or her pain level, or ask the patient to ask: How severe is participant's pain? The health care provider selects the appropriate number based on the patient's description of the pain. 1-3 points indicate mild pain, 4-6 points indicate moderate pain, and 7-10 points indicate severe pain. "The mean NRS pain score of 24 hrs" is defined as the sum of the scores within 24 hours divided by the number of evaluations within 24 hours.
Time Frame
Up to 24 hours
Title
The total dose of hydromorphone titrated from start of titration to TST
Description
The total dose of hydromorphone titrated from start of titration to TST
Time Frame
Up to 24 hours
Title
The total dose of hydromorphone titrated within 24 hrs
Description
The total dose of hydromorphone titrated within 24 hrs
Time Frame
Up to 24 hours
Title
Improvement of patient symptoms
Description
The change from baseline in questionnaire: Chinese version of the Edmonton Symptom Assessment System
Time Frame
Up to 24 hours
Title
Adverse Events
Description
treatment-related Adverse Events:
Time Frame
Up to 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: With written informed consent signed voluntarily by patients themselves. Cancer patients aged 18-70 years old. Patients with cancer pain more than or equal to NRS 7 during previous 24 hours. Patients who will not be treated with radiotherapy within 7 days prior to randomization and during study. Patients who need chemotherapy, long term administration of hormone, targeted therapy, or bisphosphonates therapy should undergo a stable anti- tumor therapy prior to randomization. Patients or his/her caregivers who are able to fill out the questionnaire forms. Ability to correctly understand and cooperate with medication guidance of doctors and nurses. Without a history of anaphylaxis of narcotic drugs. Without psychiatric problems. ECOG performance status ≤3. Not participated in another drug clinical trial within one month before inclusion（including hydromorphone）. Exclusion Criteria: Patients diagnosed with non-cancer pain or unexplained pain. Patients suffered with post-op pain. Patients having paralytic ileus. Patients who have hypersensitivity to hydromorphone. There are abnormal lab results, with obvious clinical significance, such as the creatinine ≥ 2 fold of upper limit of normal value, or ALT or AST ≥ 2.5 fold of upper limit of normal value (≥ 5 fold,to the patients with liver metastasis or primary liver cancer), or liver function of Child C grade. Patients having a incoercible Nausea and vomiting. Monoamine oxidase inhibitor (MAOI) was administrated two week before randomization. Patients who are pregnant or lactating,who plans to be pregnant within one month after the trial（including male）. Patients who are opioid abuse. Patients who are alcohol abuse. Patients who are cognitive dysfunction. Patients having a severe psychotic depression. Patients with any other medical condition or reason, in that investigator's opinion, makes the patient unable to participate in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rongbo Lin
Organizational Affiliation
Fujian Cancer Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Rongbo Lin
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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PCA vs Non-PCA Intravenous Hydromorphone Titration for Severe Cancer Pain

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