Pregabalin bone trial

Completed

Conditions: Bone metastasis
Cancer
Secondary malignant neoplasm of other sites

Registration Number: ISRCTN66947249

Lead Sponsor: othian Health Board (LHB) (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 206

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To establish if radiotherapy and pregabalin gives superior analgesia in CIBP than radiotherapy alone. <br><br>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 Outcome Measures

Name	Time	Method
1. Background, spontaneous and movement-related pain <br>2. Total opioid requirements, i.e. background and breakthrough doses<br>3. Tolerability of pregabalin<br>4. Global quality of life scores (European Quality of Life [EuroQoL] thermometer)<br>5. Hospital Anxiety and Depression (HAD) scores<br>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).<br>7. Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) only to be done in conjunction with QST <br>8. Opioid side-effects<br>9. Withdrawal from study<br>10. Serious adverse events - pregabalin <br><br>Primary and secondary outcomes will be measured at study baseline (date of first fraction of radiotherapy) and study endpoint (four weeks from study baseline).