The condition under investigation is cancer induced bone pain (CIBP). This is a major cause of morbidity in patients with cancer and unfortunately standard treatments (including radiotherapy) can be in-effective or limited by side effects. GET STUFF FROM MARIE RE THIS MedDRA version: 9.1 Level: PT Classification code 10027452 Term: Metastases to bone MedDRA version: 9.1 Level: HLT Classification code 10033372 Term: Pain and discomfort NEC
Conditions
Interventions
Trade Name: Pregabalin
Product Name: pregabalin
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Pregabalin
CAS Number: 148553-50-8
Current Sponsor code: Lyrica
Concentration unit: mg milligram
Sponsors
Lothian Health Board
University of Edinburgh
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Clearly identifiable bone pain · Index bone pain ³ 4/10 · Written informed consent · Age ³ 18 years · Able to complete necessary assessments required as part of the trial · Life expectancy > 2 months · Due to receive palliative radiotherapy for bone pain Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: · Age 1.5mg/ml, creatinine clearance< 60 mmls/hr) · Change in any tumoricidal therapy before entering the study which may be expected to have an analgesic benefit during the study period · Patients receiving bisphosphonates purely as an analgesic regimen which may be expected to have effects during the study period. (Patients on regular bisphosphonates pre occurrence of current bone pain allowed.) · Bed bound patients · Patients who are having palliative radiotherapy to vertebral metastases · Patients receiving wide-field irradiation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish if radiotherapy and pregabalin gives superior analgesia in CIBP than radiotherapy alone. ;Secondary Objective: The trial will also assess the IMP effect on: · Background, spontaneous and movement-related pain · Total opioid requirements, ie background and breakthrough doses · Global quality of life scores (Euroqol thermometer) · HAD scores · Changes in sensory responses as assessed by Quantitative Sensory Testing (QST). · Opioid side-effects · Withdrawal from study Both the tolerability and any serious adverse events of the IMP will also be assessed ;Primary end point(s): Comparison of the proportion of patients improving in the placebo arm and the active arm where an improvement is defined as a reduction of two or more points on the pain scale between baseline at the start of the “Assessment” period and end of study. The pain measured here is the worst pain in the last 24 hours at the two assessment points. In addition, the two point reduction needs to be accompanied by a stable or reduced opioid dose compared to the “Assessment” period baseline dose. | — |
Countries
United Kingdom
Outcome results
None listed