Oxycodone or Standard Pain Therapy in Treating Patients With Cancer Pain - Full Text View

Sponsored by:	University Hospitals Bristol NHS Trust
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00378937

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 IV

MedlinePlus related topics: Cancer

Drug Information available for: Oxycodone Oxycodone hydrochloride Acetaminophen Codeine Codeine phosphate Levopropoxyphene Levopropoxyphene napsylate Propoxyphene Propoxyphene hydrochloride Propoxyphene napsylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label
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

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

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

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

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000507650, CRUK-ON/2003/1772, EU-20640, EUDRACT-2004-004235-66, NAPP-CRUK-ON/2003/1772
Study First Received:	September 20, 2006
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00378937
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific
pain

Study placed in the following topic categories:

Naphazoline
Oxymetazoline
Morphine
Dextropropoxyphene
Guaifenesin
Phenylephrine

Oxycodone
Pain
Phenylpropanolamine
Acetaminophen
Codeine

Additional relevant MeSH terms:

Respiratory System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents

Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Antitussive Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 14, 2009