Oxycodone or Standard Pain Therapy in Treating Patients With Cancer Pain

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00378937
First received: September 20, 2006
Last updated: August 1, 2013
Last verified: July 2007
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

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

Estimated Enrollment: 30
Study Start Date: January 2004
Study Completion Date: February 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378937

Sponsors and Collaborators
University Hospitals Bristol NHS Trust
Investigators
Study Chair: Geoff Hanks, MD University Hospitals Bristol NHS Trust
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00378937     History of Changes
Other Study ID Numbers: CRUK-ON/2003/1772, CDR0000507650, EU-20640, EUDRACT-2004-004235-66, NAPP-CRUK-ON/2003/1772
Study First Received: September 20, 2006
Last Updated: August 1, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific
pain

Additional relevant MeSH terms:
Acetaminophen
Oxycodone
Morphine
Codeine
Dextropropoxyphene
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 18, 2014