An observational study in Cancer Pain, Real-world Study and Oxycodone, sponsored by Henan Cancer Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-27.
Sponsored by Henan Cancer Hospital · Observational
The goal of this real world study is to observe the efficacy and safety of Oxycodone Hydrochloride Sustained-release Tablets in the treatment of moderate to severe cancer pain participants in real clinical practice.
After entering the study, participants will take Oxycodone Hydrochloride Sustained-release Tablets. The investigators need to observe and record relevant data, and finally analyze and summarize the data to understand the efficacy and safety.
This study is a prospective, single arm, multicenter real world study, the investigators didn't set up a control group. After the participant is enrolled, the participant will enter a 14 day treatment cycle, where the medication will be proportionally converted into Oxycodone Hydrochloride Sustained-release Tablets. The daily medication dose will be adjusted based on the number of pain outbreaks and pain scores (According to the drug increment principle of NCCN), and various information (Daily oxycodone dose, average pain score, minimal pain score, most severe pain score, number of breakout pain, name of rescue drugs, number of rescue, heart rate, blood pressure, respiratory rate, SPO2, combination of drugs, pain control satisfaction, etc) about the participant's medication will be recorded. The participant will not be limited to whether to combine medication. Observe the efficacy and safety of Oxycodone Hydrochloride Sustained-release Tablets.
338 studies on the registry are indexed under Cancer Pain; 71 are open to participants now.
This study's planned enrollment of 916 is above the median of 140 across 68 observational studies indexed under Cancer Pain.
Browse Cancer Pain studies →Henan Cancer Hospital is the lead sponsor of 228 studies on the registry; 130 are open to participants now.
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This study is a prospective, single arm, multicenter real-world study that only needs to meet the requirements of age, disease type, drug dosage, and no severe mental illness in the study population
Exclusion Criteria:
Mean difference in pain intensity after treatment
Use the Numeric Rating Scale（NRS, 0 to 10 points, lower scores indicate better pain control） to evaluate the average pain score per day over the past 24 hours. Calculate the daily difference in pain intensity (PID) by subtracting the daily NRS score from the baseline NRS score. Divide the sum of PID on days 1 to 14 by 14 to obtain the mean difference in pain intensity (MPID).
Time frame: From the 1st to 14th day of treatment
The proportion of patients with effective pain relief
Effective pain relief is defined as a decrease of 30% or more in average pain intensity from day 1 to day 14 compared to the baseline period.
Time frame: From the 1st to 14th day of treatment
The proportion of patients with effective pain control
The proportion of patients whose pain is under control. It requires the Numeric Rating Scale (NRS, 0 to 10 points, lower scores indicate better pain control) is ≤ 3 points, and the break-through cancer pain is ≤ 3 times per day.
Time frame: From the 1st to 14th day of treatment
The time for the patient's pain to be effectively controlled
The time from the beginning of treatment to effective pain control for patients. It requires the Numeric Rating Scale (NRS, 0 to 10 points, lower scores indicate better pain control) is ≤ 3 points, and the break-through cancer pain is ≤ 3 times per day.
Time frame: From the 1st to 14th day of treatment
The improvement of patient symptoms
We use the Brief Pain Inventory (BPI) to evaluate the improvement of patient symptoms. There are a total of 7 projects, with each project scoring 0-10 points. The lower the score, the more significant the improvement in symptoms.
Time frame: On the 3rd, 7th, and 14th days after treatment
The satisfaction with pain control
0-10 points (the higher the score, the higher the satisfaction), participants can rate treatment satisfaction based on the efficacy and safety of the experimental drug. It's the patient's subjective perception of pain control.
Time frame: On the 3rd, 7th, and 14th days after treatment
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Henan Cancer Hospital