Oxycodone or Standard Pain Therapy in Treating Patients With Cancer Pain
RATIONALE: Oxycodone helps lessen pain caused by cancer and may improve quality of life. It is not yet known whether oxycodone works better and is more cost effective than standard therapy in treating patients with cancer pain.
PURPOSE: This randomized phase IV trial is studying oxycodone to see how well it works compared with standard pain therapy in treating patients with cancer pain and if it is more cost effective than standard pain therapy.
|Pain Unspecified Adult Solid Tumor, Protocol Specific||Drug: acetaminophen Drug: codeine phosphate Drug: dextropropoxyphene hydrochloride Drug: morphine sulfate Drug: oxycodone hydrochloride Procedure: management of therapy complications Procedure: quality-of-life assessment||Phase 4|
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||An Open, Randomized, Parallel Group Study in Patients With Cancer Pain, To Compare a Two-Step Analgesic Ladder (Non-Opioid to Oxycodone) With Conventional Management Using A Three-Step Approach|
- Percentage of time in assessment periods 1 and 2 (i.e., first 4 weeks) with a Box-Scale (BS)-11 pain score of ≤ 4 (i.e., mild pain)
- Percentage of time in assessment periods 3 and 4 with a BS-11 pain score of ≤ 4
- Mean BS-11 pain scores
- Time to reach stable pain control
- Mean escape medication use
- Quality of sleep
- Global assessment of pain relief with study drugs
- Mean pain intensity, pain interference, and pain relief scores as measured by the Brief Pain Inventory
- Overall number of phone calls, home visits by a nurse, home visits by a doctor, and unscheduled visits to a healthcare provider, related to pain control or analgesic medication during study treatment
|Study Start Date:||January 2004|
|Study Completion Date:||February 2006|
- Compare overall pain management in patients with cancer-related pain treated with oxycodone hydrochloride vs standard three-step analgesic therapy.
- Compare the health economics of these regimens in these patients.
- Explore the factors that inform patients' decisions about commencing opioid analgesia.
OUTLINE: This is an open-label, multicenter, randomized, parallel group, pilot study. Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive an analgesic regimen, according to their level of pain, for up to 18 weeks.
- Step 1: Patients in mild pain receive oral acetaminophen 4 times daily.
- Step 2: Patients in mild-to-moderate pain receive oral codeine or oral dextropropoxyphene hydrochloride 4 times daily and oral acetaminophen 4 times daily.
- Step 3: Patients in moderate-to-severe pain receive oral morphine or oral oxycodone hydrochloride 6 times daily (every 4 hours) with or without a non-opioid analgesic.
Patients may also receive an adjuvant drug (i.e., for side effects or for primary indication other than pain management that is analgesic in selected circumstances).
- Arm II: Patients receive oral oxycodone hydrochloride twice daily for up to 18 weeks. Patients may receive a different opioid analgesic or analgesia or adjuvant medication as in arm I, if needed.
Patients in both arms may also receive additional medication for breakthrough pain.
Patients complete a patient-assessment booklet (PAB) daily which includes a Box-Scale (BS)-11 rating for average pain; questions regarding contact (e.g., telephone or visit) with healthcare professionals on that day; and information regarding the number of times escape medication is used.
Quality of life and levels of cancer pain are assessed using the short form of the Brief Pain Inventory (BPI).
After completion of study treatment, patients are followed at 4 weeks.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00378937
|Study Chair:||Geoff Hanks, MD||University Hospitals Bristol NHS Foundation Trust|