An International, Multicentre, Open Randomised Parallel Group Trial Comparing a Two Step Approach for Cancer Pain Relief With the Standard Three Step Approach of the WHO Analgesic Ladder in Patients With Cancer Pain Requiring Step 2 Analgesia.
18 Years
N/A
Both
Cancer, Pain
Trial Information
An International, Multicentre, Open Randomised Parallel Group Trial Comparing a Two Step Approach for Cancer Pain Relief With the Standard Three Step Approach of the WHO Analgesic Ladder in Patients With Cancer Pain Requiring Step 2 Analgesia.
Inclusion Criteria:
- 18 years of age and over.
- Patient has a cancer diagnosis (based on radiological, histological, cytological, or
operative evidence). Those with haematological malignancies are eligible.
- Cancer related pain - which in the opinion of the clinician is caused by the presence
of tumour or metastases.
- Average pain score > 4, on a numerical rating scale from 0-10, requiring step 2
analgesia (weak opioid).
- Patient is able to comply with trial procedures.
Exclusion Criteria:
- Patients who have received radiotherapy in the previous 6 weeks or are planned to
receive radiotherapy during the trial period where in either case, it is expected to
affect pain during the trial period.
- Pain due to surgery in the preceding 4 weeks.
- Life expectancy less than two months (based on clinical impression).
- Patients with psychotic disorders or cognitive impairment.
- Patients who have received regular doses (scheduled doses - NOT as required dosing)
of weak or strong opioids in the preceding two weeks.
- Patients using immediate release opioids > 2 doses/24 hours, in the previous 24
hours.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Time to achieving stable pain control, where stable pain control is defined as the first day of three consecutive days with average pain score less than or equal to 3 using scores from the Patient Diary and patient assessments.
Outcome Time Frame:
Up to 20 days
Safety Issue:
No
Principal Investigator
Marie Fallon
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Edinburgh
Authority:
United Kingdom: Research Ethics Committee
Study ID:
11/SS/0079
NCT ID:
NCT01493635
Start Date:
March 2012
Completion Date:
December 2014
Related Keywords:
- Cancer
- Pain
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