Bone metastasis Cancer Secondary malignant neoplasm of other sites
Conditions
Interventions
This study will be a double-blind randomised controlled trial. Patients who are due to receive palliative radiotherapy to cancer induced bone pain will be assessed, if agreeable, for inclusion in the
Sponsors
Lothian Health Board (LHB) (UK)
University of Edinburgh (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Clearly identifiable bone pain 2. Index bone pain greater than or equal to 4/10 3. Written informed consent 4. Aged greater than or equal to 18 years, either sex 5. Able to complete necessary assessments required as part of the trial 6. Life expectancy greater than two months 7. Due to receive palliative radiotherapy for bone pain
Exclusion criteria
Exclusion criteria: 1. Aged less than 18 years 2. Current gabapentin/pregabalin use 3. Significant renal impairment (plasma creatinine greater than 1.5 mg/ml, creatinine clearance less than 60 mmls/hr) 4. Change in any tumoricidal therapy before entering the study which may be expected to have an analgesic benefit during the study period 5. 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) 6. Bed-bound patients 7. Patients who are having palliative radiotherapy to vertebral metastases 8. Patients receiving wide-field irradiation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To establish if radiotherapy and pregabalin gives superior analgesia in CIBP than radiotherapy alone. Primary and secondary outcomes will be measured at study baseline (date of first fraction of radiotherapy) and study endpoint (four weeks from study baseline). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Background, spontaneous and movement-related pain 2. Total opioid requirements, i.e. background and breakthrough doses 3. Tolerability of pregabalin 4. Global quality of life scores (European Quality of Life [EuroQoL] thermometer) 5. Hospital Anxiety and Depression (HAD) scores 6. Changes in sensory responses as assessed by Quantitative Sensory Testing (QST). Modified short version for those patients who want to complete this (20 minutes). 7. Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) only to be done in conjunction with QST 8. Opioid side-effects 9. Withdrawal from study 10. Serious adverse events - pregabalin Primary and secondary outcomes will be measured at study baseline (date of first fraction of radiotherapy) and study endpoint (four weeks from study baseline). | — |
Countries
United Kingdom
Outcome results
None listed