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
- 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
- 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
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.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care
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)
Geoff Hanks, MD
University Hospitals Bristol NHS Trust
United States: Federal Government