Oxycodone or Standard Pain Therapy in Treating Patients With Cancer Pain

Sponsor

University Hospitals Bristol and Weston NHS Foundation Trust (Other)

Overall Status

Completed

CT.gov ID

NCT00378937

Collaborator

(none)

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
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

Detailed Description

OBJECTIVES:

Primary

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.

Secondary

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Masking:

None (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

Study Start Date :

Jan 1, 2004

Actual Study Completion Date :

Feb 1, 2006

Outcome Measures

Primary Outcome Measures

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) []

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Diagnosis of cancer
Requires regular step-2 analgesia for the management of cancer-related pain

PATIENT CHARACTERISTICS:

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:
Depression
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