Oxycodone or Standard Pain Therapy in Treating Patients With Cancer Pain

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)

Secondary outcome:

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

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: January 2004
Last updated: May 23, 2008