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Oxycodone or Standard Pain Therapy in Treating Patients With Cancer Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00378937
Recruitment Status : Completed
First Posted : September 21, 2006
Last Update Posted : August 2, 2013
Information provided by:
National Cancer Institute (NCI)

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:



  • 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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 2004
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Oxycodone

Primary Outcome Measures :
  1. 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 :
  1. Percentage of time in assessment periods 3 and 4 with a BS-11 pain score of ≤ 4
  2. Mean BS-11 pain scores
  3. Time to reach stable pain control
  4. Mean escape medication use
  5. Quality of sleep
  6. Global assessment of pain relief with study drugs
  7. Mean pain intensity, pain interference, and pain relief scores as measured by the Brief Pain Inventory
  8. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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:

    • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00378937

Sponsors and Collaborators
University Hospitals Bristol NHS Foundation Trust
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Study Chair: Geoff Hanks, MD University Hospitals Bristol NHS Foundation Trust
Layout table for additonal information Identifier: NCT00378937    
Other Study ID Numbers: CRUK-ON/2003/1772
CDR0000507650 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: September 21, 2006    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: July 2007
Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific
Additional relevant MeSH terms:
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Cancer Pain
Neurologic Manifestations
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Antitussive Agents
Respiratory System Agents