Clinical trial NCT04243954: Intravenous vs Oral Analgesia in Cancer Patients With Severe Pain After Successful Titration
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer Pain
Keywords: Orally
PCA intravenously
Analgesia
Severe cancer pain
Lead sponsor: Fujian Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2020-01-28
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. The patients were 18-80 years old and diagnosed as malignant tumor by pathology;
2. Patients with cancer pain is NRS pain score ≥ 7 during previous 24 hours;
3. Patients who will not be treated with radiotherapy within 7 days prior to randomization and during study ;
4. Patients who need chemotherapy, long term administration of hormone, targeted therapy, or bisphosphonates therapy should undergo a stable anti- tumor therapy prior to randomization ;
5. Patients or his/her caregivers who are able to fill out the questionnaire forms ;
6. Ability to correctly understand and cooperate with medication guidance of doctors and nurses ;
7. Without psychiatric problems;
8. ECOG performance status ≤3;
9. Not participated in another drug clinical trial within one month before inclusion（including hydromorphone）;
10. The subjects voluntarily signed the informed consent.

Exclusion Criteria:

1. The pain is confirmed not due to cancer;
2. Patients with severe post-operative pain;
3. Patients with paralytic ileus;
4. Patients with brain metastasis;
5. Patients hypersensitive to opioids;
6. 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;
7. Patients who cannot take drugs orally;
8. Patients with an incoercible nausea or vomiting;
9. Those who have received monoamine oxidase inhibitor (MAOI) within two weeks before randomization;
10. Patients who are pregnant or in lactation, or who plan to be pregnant within one month after the trial;
11. Those with opioid addiction;
12. Alcoholic patients;
13. Those with cognitive dysfunction;
14. Those with severe depression;
15. Patients with other conditions or reasons causing the patients unable to complete the clinical trial.

Primary outcomes:
measure: Mean pain score
timeFrame: From day1 to day3
measure: Number of Breakthrough cancer Pain (BTcP) episodes
timeFrame: From day1 to day3
Secondary outcomes:
measure: Number of patients with an average NRS pain score> 3
timeFrame: From day1 to day3
measure: Number of patients with an average NRS pain score> 6
timeFrame: From day1 to day3
measure: Total dosage of opioids
timeFrame: 3 days
measure: Satisfaction score
timeFrame: 3 days
measure: Quality of life of patients
timeFrame: At 24 hours
measure: Number of patients who switched/discontinued therapy due to serious adverse events or lack of pain control
timeFrame: 3 days
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: China, Fujian
state: Fujian
Study officials:
affiliation: Fujian Cancer Hospital
name: Rongbo Lin, MD
role: PRINCIPAL_INVESTIGATOR
References: