Cancer, Pain
Conditions
Brief summary
The World Health Organization analgesic ladder for cancer pain relief is an internationally used approach to managing cancer pain. Patients generally start on Step 1 of the ladder (paracetamol). As pain increases or is not well controlled on this, they progress to Step 2 which involves a stronger pain killer (weak opioid such as codeine). If pain is still not controlled they progress to Step 3 of the ladder which is a strong opioid (such as morphine). Work to date has suggested that Step 2 may be unnecessary and most patients usually require Step 3 analgesia. The TVT trial aims to examine the standard approach (Step 1-Step2-Step-3) versus a two step approach (Step 1-Step 3).
Interventions
OTHERanalgesic ladder
Patients will be managed according to the standard 3 Step approach of the WHO analgesic ladder (Step 1 - Step 2 - Step 3).
Sponsors
NHS Lothian
University of Edinburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | Up to 20 days |
Countries
United Kingdom
Outcome results
None listed