Cancer PainPhase 2NCT04243954
Intravenous vs Oral Analgesia in Cancer Patients With Severe Pain After Successful Titration
A Phase 2 study testing PCA IV Hydromorphone (continuous dose = 0), PCA IV Hydromorphone (continuous dose ≠ 0) and Oral morphine in people with Cancer Pain, run by Fujian Cancer Hospital at 1 site in China.
Trial summary
Pain is one of the most common and fear symptoms for cancer patients, which seriously affects the quality of life in cancer patients. At present, oral opioid is the most common route to administrate cancer pain. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer Pain
- What is being tested?
- PCA IV Hydromorphone (continuous dose = 0), PCA IV Hydromorphone (continuous dose ≠ 0) and Oral morphine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2020to 21 Nov 2020
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients were 18-80 years old and diagnosed as malignant tumor by pathology;
- Patients with cancer pain is NRS pain score ≥ 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 ;
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- Without psychiatric problems;
- ECOG performance status ≤3;
- Not participated in another drug clinical trial within one month before inclusion（including hydromorphone）;
- The subjects voluntarily signed the informed consent.
Who cannot join
- The pain is confirmed not due to cancer;
- Patients with severe post-operative pain;
- Patients with paralytic ileus;
- Patients with brain metastasis;
- Patients hypersensitive to opioids;
- Patients with abnormal lab results that have obvious clinical significance, such as creatine ≥ 2 fold of upper limit of normal value, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 fold of upper limit of normal value, or liver function of Child C grade;
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- Patients who cannot take drugs orally;
- Patients with an incoercible nausea or vomiting;
- Those who have received monoamine oxidase inhibitor (MAOI) within two weeks before randomization;
- Patients who are pregnant or in lactation, or who plan to be pregnant within one month after the trial;
- Those with opioid addiction;
- Alcoholic patients;
- Those with cognitive dysfunction;
- Those with severe depression;
- Patients with other conditions or reasons causing the patients unable to complete the clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hydromorphone PCA Intravenously vs Sustained-Release Morphine Orally in Cancer Patients With Severe Pain After Successful Titration: A Multicenter, Randomized, Controlled, Phase II Trial
Pain is one of the most common and fear symptoms for cancer patients, which seriously affects the quality of life in cancer patients. At present, oral opioid is the most common route to administrate cancer pain. However, the patients do not satisfy the pain administration with oral opioid after successful titration in many cases, especially the cases with severe cancer pain. Patient controlled analgesia (PCA) with hydromorphone can take analgesic effect rapidly. The aim of this trial is to compare the maintenance with hydromorphone PCA intravenously or switch to Sustained-Release Morphine orally after successful titraton with hydromorphone PCA intravenously in severe cancer pain.
- Conditions
- Cancer Pain
- Being tested
- PCA IV Hydromorphone (continuous dose = 0), PCA IV Hydromorphone (continuous dose ≠ 0), Oral morphine
- Keywords
- Orally, PCA intravenously, Analgesia, Severe cancer pain
- Medical subject headings
- Cancer Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCA IV Hydromorphone (continuous dose = 0)Drug
Intravenous PCA with hydromorphone after successful titration of 24 hours. the PCA setting: 1) continuous dose = 0; 2) bolus dose = 10-20% of the total dosage of hydromorphone in the previous 24 hours: 3) lockout time = 10 minutes; 4) evaluate once every 24 hours
PCA IV Hydromorphone (continuous dose ≠ 0)Drug
Intravenous PCA with hydromorphone after successful titration of 24 hours. the PCA setting: 1) continuous dose (dose/hours) = the total dosage of hydromorphone in the previous 24 hours/24; 2) bolus dose = 10-20% of the total dosage of hydromorphone in the previous 24 hours; 3) lockout time = 10 minutes; 4) evaluate once every 24 hours
Oral morphineDrug
Swift to sustained-release morphine orally as background dose with immediate release morphine orally for breakthrough pain after successful titration of 24 hours.
Administration of morphine orally 1) Sustained-release morphine orally (dose/12 hours) = the total equianalgesic of the previous 24 hours/2×75% for d1; the total equianalgesic of the previous 24 hours/2 for day 2 and day 3; 2) Immediate release morphine orally = 10-20% of the total equianalgesic of the previous 24 hours; 3) Evaluate once every 24 hours
| Study group | Role | What they receive |
|---|---|---|
| PCA IV Hydromorphone (continuous dose = 0) | Experimental | 1. Intravenous PCA with hydromorphone after successful titration of 24 hours.
2. The PCA setting:
1) Continuous dose = 0; 2) Bolus dose = 10-20% of the total dosage of hydromorphone in the previous 24 hours: 3) Lockout time = 10 minutes; 4) Evaluate once every 24 hours Receives: Drug: PCA IV Hydromorphone (continuous dose = 0) |
| PCA IV Hydromorphone (continuous dose ≠ 0) | Experimental | 1. Intravenous PCA with hydromorphone after successful titration of 24 hours.
2. The PCA setting:
1) Continuous dose (dose/hours) = the total dosage of hydromorphone in the previous 24 hours/24; 2) Bolus dose = 10-20% of the total dosage of hydromorphone in the previous 24 hours; 3) Lockout time = 10 minutes; 4) Evaluate once every 24 hours Receives: Drug: PCA IV Hydromorphone (continuous dose ≠ 0) |
| Oral Morphine | Active comparator | 1. Swift to sustained-release morphine orally as background dose with immediate release morphine orally for breakthrough pain after successful titration of 24 hours.
2. Administration of morphine orally 1) Sustained-release morphine orally (dose/12 hours) = the total equianalgesic of the previous 24 hours/2×75% for d1; the total equianalgesic of the previous 24 hours/2 for day 2 and day 3; 2) Immediate release morphine orally = 10-20% of the total equianalgesic of the previous 24 hours; 3) Evaluate once every 24 hours Receives: Drug: Oral morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean pain score
The Numerical Rating Scale (NRS, a score of 0 means no pain and 10 means the most severe) is used to assess the severity of pain. NRS of 24 hours is assessed every day. The mean pain score is a sum of NRS of day 1 (the day after successful titration of 24 hours) to day 3 divided by 3.
If the NRS of the morphine orally group >3, the NRS in the hydromorphone PCA intravenously group declines more than 30% compared to morphine orally group, which is regards a positive result.
Measured: From day1 to day3
Number of Breakthrough cancer Pain (BTcP) episodes
If NRS of the morphine orally group pain score ≤3 , or if NRS in the hydromorphone PCA intravenously group declines less than 30% compared to morphine orally group, number of Breakthrough cancer Pain (BTcP) episodes in the one of both the hydromorphone PCA intravenously group declines less than 30% compared to morphine orally group, which is regards a positive result.
Measured: From day1 to day3
Secondary outcomes (6)
Number of patients with an average NRS pain score> 3
The Numerical Rating Scale (NRS, a score of 0 means no pain and 10 means the most severe) is used to assess the severity of pain.
Measured: From day1 to day3
Number of patients with an average NRS pain score> 6
The Numerical Rating Scale (NRS, a score of 0 means no pain and 10 means the most severe) is used to assess the severity of pain.
Measured: From day1 to day3
Total dosage of opioids
The total dosage of opioids in day 1 to day 3 (day 1 is the day after successful titration of 24 hours)
Measured: 3 days
Satisfaction score
The satisfaction score of the patients to analgesia was evaluated by 10-point scale: 0 points for dissatisfaction, 10 points for very satisfied, the higher the score, the higher the satisfaction.
Measured: 3 days
Quality of life of patients
Chinese version of the Edmonton Symptom Assessment System.
Measured: At 24 hours
Number of patients who switched/discontinued therapy due to serious adverse events or lack of pain control
The number of patients who switched/discontinued therapy due to serious adverse events or lack of pain control
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start10 Apr 2020
- Primary completion21 Oct 2020
- Study completion21 Nov 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Rongbo Lin, MD, Principal investigator, Fujian Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04243954
- Sponsor's protocol ID
- HMORCT09-2
- Status last verified
- Feb 2021
- First submitted
- 10 Jan 2020
- Last updated
- 5 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 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydromorphone PCA Intravenously vs Sustained-Release Morphine Orally in Cancer Patients With Severe Pain After Successful Titration: A Multicenter, Randomized, Controlled, Phase II Trial
- ClinicalTrials.gov ID
- NCT04243954
- Acronym / sponsor ID
- HMORCT09-2
- Conditions
- Cancer Pain
- Keywords
- Orally, PCA intravenously, Analgesia, Severe cancer pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 10 Apr 2020 (actual)
- Primary completion
- 21 Oct 2020 (actual)
- Study completion
- 21 Nov 2020 (actual)
- First posted
- 28 Jan 2020 (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.
Pain is one of the most common and fear symptoms for cancer patients, which seriously affects the quality of life in cancer patients. At present, oral opioid is the most common route to administrate cancer pain. However, the patients do not satisfy the pain administration with oral opioid after successful titration in many cases, especially the cases with severe cancer pain. Patient controlled analgesia (PCA) with hydromorphone can take analgesic effect rapidly. The aim of this trial is to compare the maintenance with hydromorphone PCA intravenously or switch to Sustained-Release Morphine orally after successful titraton with hydromorphone PCA intravenously in severe cancer pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PCA IV Hydromorphone (continuous dose = 0) | Experimental | Drug: PCA IV Hydromorphone (continuous dose = 0)1. Intravenous PCA with hydromorphone after successful titration of 24 hours. 2. The PCA setting: 1) Continuous dose = 0; 2) Bolus dose = 10-20% of the total dosage of hydromorphone in the previous 24 hours: 3) Lockout time = 10 minutes; 4) Evaluate once every 24 hours |
| PCA IV Hydromorphone (continuous dose ≠ 0) | Experimental | Drug: PCA IV Hydromorphone (continuous dose ≠ 0)1. Intravenous PCA with hydromorphone after successful titration of 24 hours. 2. The PCA setting: 1) Continuous dose (dose/hours) = the total dosage of hydromorphone in the previous 24 hours/24; 2) Bolus dose = 10-20% of the total dosage of hydromorphone in the previous 24 hours; 3) Lockout time = 10 minutes; 4) Evaluate once every 24 hours |
| Oral Morphine | Active comparator | Drug: Oral morphine1. Swift to sustained-release morphine orally as background dose with immediate release morphine orally for breakthrough pain after successful titration of 24 hours. 2. Administration of morphine orally 1) Sustained-release morphine orally (dose/12 hours) = the total equianalgesic of the previous 24 hours/2×75% for d1; the total equianalgesic of the previous 24 hours/2 for day 2 and day 3; 2) Immediate release morphine orally = 10-20% of the total equianalgesic of the previous 24 hours; 3) Evaluate once every 24 hours |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The patients were 18-80 years old and diagnosed as malignant tumor by pathology;
- Patients with cancer pain is NRS pain score ≥ 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 ;
Key exclusion criteria (15 listed)
- The pain is confirmed not due to cancer;
- Patients with severe post-operative pain;
- Patients with paralytic ileus;
- Patients with brain metastasis;
- Patients hypersensitive to opioids;
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 |
|---|---|---|
| PCA IV Hydromorphone (continuous dose = 0)Intravenous PCA with hydromorphone after successful titration of 24 hours. the PCA setting: 1) continuous dose = 0; 2) bolus dose = 10-20% of the total dosage of hydromorphone in the previous 24 hours: 3) lockout time = 10 minutes; 4) evaluate once every 24 hours | Drug | PCA IV Hydromorphone (continuous dose = 0) |
| PCA IV Hydromorphone (continuous dose ≠ 0)Intravenous PCA with hydromorphone after successful titration of 24 hours. the PCA setting: 1) continuous dose (dose/hours) = the total dosage of hydromorphone in the previous 24 hours/24; 2) bolus dose = 10-20% of the total dosage of hydromorphone in the previous 24 hours; 3) lockout time = 10 minutes; 4) evaluate once every 24 hours | Drug | PCA IV Hydromorphone (continuous dose ≠ 0) |
| Oral morphineSwift to sustained-release morphine orally as background dose with immediate release morphine orally for breakthrough pain after successful titration of 24 hours. Administration of morphine orally 1) Sustained-release morphine orally (dose/12 hours) = the total equianalgesic of the previous 24 hours/2×75% for d1; the total equianalgesic of the previous 24 hours/2 for day 2 and day 3; 2) Immediate release morphine orally = 10-20% of the total equianalgesic of the previous 24 hours; 3) Evaluate once every 24 hours | Drug | Oral Morphine |
Primary outcome
Mean pain score
Time frame: From day1 to day3
The Numerical Rating Scale (NRS, a score of 0 means no pain and 10 means the most severe) is used to assess the severity of pain. NRS of 24 hours is assessed every day. The mean pain score is a sum of NRS of day 1 (the day after successful titration of 24 hours) to day 3 divided by 3. If the NRS of the morphine orally group >3, the NRS in the hydromorphone PCA intravenously group declines more than 30% compared to morphine orally group, which is regards a positive result.
Number of Breakthrough cancer Pain (BTcP) episodes
Time frame: From day1 to day3
If NRS of the morphine orally group pain score ≤3 , or if NRS in the hydromorphone PCA intravenously group declines less than 30% compared to morphine orally group, number of Breakthrough cancer Pain (BTcP) episodes in the one of both the hydromorphone PCA intravenously group declines less than 30% compared to morphine orally group, which is regards a positive result.
6 secondary outcomes
Number of patients with an average NRS pain score> 3
Time frame: From day1 to day3
Number of patients with an average NRS pain score> 6
Time frame: From day1 to day3
Total dosage of opioids
Time frame: 3 days
Satisfaction score
Time frame: 3 days
Quality of life of patients
Time frame: At 24 hours
Number of patients who switched/discontinued therapy due to serious adverse events or lack of pain control
Time frame: 3 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 5 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, MD principal investigator
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 2 study testing PCA IV Hydromorphone (continuous dose = 0), PCA IV Hydromorphone (continuous dose ≠ 0) and Oral morphine 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 10 inclusion and 15 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 5 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Mean pain score (time frame: From day1 to day3). The study lists 2 primary outcomes in all. 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 5 Mar 2021.