Oxycodone or Standard Pain Therapy in Treating Patients With Cancer Pain
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain; Unspecified Adult Solid Tumor, Protocol Specific
Intervention: acetaminophen (Drug); codeine phosphate (Drug); dextropropoxyphene hydrochloride (Drug); morphine sulfate (Drug); oxycodone hydrochloride (Drug); management of therapy complications (Procedure); quality-of-life assessment (Procedure)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Bristol Haematology and Oncology Centre
Official(s) and/or principal investigator(s):
Geoff Hanks, MD, Study Chair, Affiliation: Bristol Haematology and Oncology Centre
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.
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
Study design: Supportive Care, Randomized, Open Label
Primary outcome: 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
- 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
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.
Minimum age: 18 Years.
Maximum age: N/A.
- Diagnosis of cancer
- Requires regular step-2 analgesia for the management of cancer-related pain
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Must be able to take oral medication
- Must be willing and able to complete a daily patient assessment booklet (PAB)
- No history of the following conditions:
- Personality disorders that may lead to self-harm
- Admission to the hospital for psychiatric reasons
- Any other psychological disorder that, in the opinion of the investigator, would
preclude study treatment
- Not at risk of additional CNS depressant effects due to study drugs
- No known history of alcohol or drug abuse or, in the opinion of the investigator,
tendency towards drug abuse or addiction
- No current abuse of alcohol or drugs
- No known sensitivity to oxycodone hydrochloride or other opioids
- No history of a specific or allergic reaction to study drugs
- No contraindications as a result of adverse drug reaction or drug interactions of
oxycodone or other opioid drugs
- No other condition that, in the opinion of the investigator, would make the patient
unsuitable for study participation
PRIOR CONCURRENT THERAPY:
- More than 30 days since prior and no concurrent chemotherapy or radiotherapy
- At least 2 weeks since prior regular (i. e., 4 times per day) step-2 analgesics
- More than 3 months since prior regular use of opioids, defined as having a regular
prescription of an opioid medication
- Not planning to undergo cancer-related surgery
- No other concurrent opioid-based medication other than oxycodone hydrochloride
capsules as escape medication (arm II)
- No concurrent participation in another clinical trial involving a new chemical entity
Locations and Contacts
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: January 2004
Last updated: May 23, 2008