A Randomised, Open-label, Parallel Group Study Comparing the Efficacy and Safety of Kapanol Administered Every 12 Hours to 24 Hours in Patients with Moderate to Severe Cancer Pain
Leelanuntakit S
Pain Clinic, National Cancer Institute, Department of Medical Services, Ministry of Public Health, Bangkok
A randomised, open-label parallel group study comparing the efficacy and safety of Kapanol capsules administered every 12 hours to every 24 hours to patients with moderate to severe cancer related pain. Thirty advanced or terminal stage cancer patients with life expectancy of more than 8 weeks, aged 18 years old or over who were inpatients at pain clinic service and requiring oral morphine for analgesia were recruited. They were converted to receive Kapanol capsules for the Lead-in Period for 3-14 days with rescue medication not more than 2 dosages per day and maintained at a constant dosage for at least 3 days. Fifteen patients were randomised into group A for Kapanol capsules every 24 hours regimen and the rest into group B for Kapanol capsules every 12 hours regimen as the Treatment period for 7 days. Immediate release morphine solution was available as rescue medication for breakthrough or incidental pain. One patient in Group A dropped out before completing the study due to the knowledge of his poor prognosis. Even though the disease in these patients were advanced and had metastasized to vital organs, there were only four patients in these two study groups with elevation of liver function tests and all were due to the disease process. The vital signs of both study groups on the day before the Lead-in Peroid and on the day after the Treatment Period were not significantly different. Patients's pain assessments by using visual analogue scale were not significantly different during both regiments. The quality of life and the Karnofsky scales were similar at the time before the Lead-in Period, during the Lead-in Period and in both regimens. No serious adverse effects such as depressed respiration and hypotension were seen during the study phases. "Rescue Immediate Release Morphine Solution" was used in 12 patients, six in each group and all for incidental pain. The efficacy on pain control was evaluated by suing the patients' pain assessment score and this was not different statistically. The patient's assessment about the efficacy on pain control was more than 80% in the good and very good levels for both groups. There were no statistically different patient preferences for previous morphine regimens, Kapanol capsules every 24 hours regimen seemed to be more advantageous. In the investigator's opinion, Kapanol capsules in more convenient for use in tube feeding in cancer patients, as the capsules can be detached and the pellets released into the feeding tube.
วิสัญญีสาร ปี 2542, July-September ปีที่: 25 ฉบับที่ 3 หน้า 201-211