Cancer PainPhase 3NCT03375515
PCA vs Non-PCA Intravenous Hydromorphone Titration for Severe Cancer Pain
A Phase 3 study testing Hydromorphone and PCA pump in people with Cancer Pain, run by Fujian Cancer Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cancer Pain
- What is being tested?
- Hydromorphone and PCA pump
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteChina
- Study dates
- 29 Sep 2018to 10 Jan 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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）.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Cancer Pain
- Being tested
- Hydromorphone, PCA pump
- Keywords
- hydromorphone titration
- Medical subject headings
- Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydromorphoneDrug
- 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.
PCA pumpDevice
- 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.
| Study group | Role | What they receive |
|---|---|---|
| PCA IV Hydromorphone titration | Experimental | 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. Receives: Drug: Hydromorphone; Device: PCA pump |
| non-PCA IV Hydromorphone titration | Active comparator | 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. Receives: Drug: Hydromorphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: In 24 hours
Secondary outcomes (7)
The percentage of patients titrated successfully within 60 minutes
The percentage of patients who titrated successfully within 60 minutes
Measured: Up to 60 minutes
The percentage of patients titrated successfully within 24 hours
The percentage of patients who titrated successfully within 24 hours
Measured: Up to 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.
Measured: Up to 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
Measured: Up to 24 hours
The total dose of hydromorphone titrated within 24 hrs
The total dose of hydromorphone titrated within 24 hrs
Measured: Up to 24 hours
Improvement of patient symptoms
The change from baseline in questionnaire: Chinese version of the Edmonton Symptom Assessment System
Measured: Up to 24 hours
Adverse Events
treatment-related Adverse Events:
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start29 Sep 2018
- Primary completion10 Dec 2019
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Rongbo Lin, Study director, Fujian Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03375515
- Sponsor's protocol ID
- HMORCT09-1
- Status last verified
- Apr 2020
- First submitted
- 13 Dec 2017
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03375515
- Acronym / sponsor ID
- HMORCT09-1
- Conditions
- Cancer Pain
- Keywords
- hydromorphone titration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 29 Sep 2018 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 18 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCA IV Hydromorphone titration | Experimental | Drug: Hydromorphone, Device: PCA pumpPCA 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 IV Hydromorphone titration | Active comparator | Drug: HydromorphoneNon-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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydromorphone1. 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. 2. 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. | Drug | PCA IV Hydromorphone titration, non-PCA IV Hydromorphone titration |
| PCA pump1. For opioid-intolerant patients: initial dose 0.5 mg intravenous hydromorphone. 2. 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. | Device | PCA IV Hydromorphone titration |
Primary outcome
The time of successful titration in 24 hours
Time frame: 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.
7 secondary outcomes
The percentage of patients titrated successfully within 60 minutes
Time frame: Up to 60 minutes
The percentage of patients titrated successfully within 24 hours
Time frame: Up to 24 hours
The mean NRS pain score of 24 hours
Time frame: Up to 24 hours
The total dose of hydromorphone titrated from start of titration to TST
Time frame: Up to 24 hours
The total dose of hydromorphone titrated within 24 hrs
Time frame: Up to 24 hours
Improvement of patient symptoms
Time frame: Up to 24 hours
Adverse Events
Time frame: Up to 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rongbo Lin study director
Fujian Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydromorphone and PCA pump in people with Cancer Pain, run by Fujian Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time of successful titration in 24 hours (time frame: In 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2021.