Oxycodone or Standard Pain Therapy in Treating Patients With Cancer Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Pain, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: acetaminophen
* Drug: codeine phosphate
* Drug: dextropropoxyphene hydrochloride
* Drug: morphine sulfate
* Drug: oxycodone hydrochloride
* Procedure: management of therapy complications
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: acetaminophen|nan|
|Drug: codeine phosphate|nan|
|Drug: dextropropoxyphene hydrochloride|nan|
|Drug: morphine sulfate|nan|
|Drug: oxycodone hydrochloride|nan|
|Procedure: management of therapy complications|nan|
|Procedure: quality-of-life assessment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unspecified adult solid tumor, protocol specific, pain