Clinical trial · Interventional
Two Step Versus the Standard Three Step Approach of the WHO Analgesic Ladder for Cancer Pain Relief.
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| analgesic ladder | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard 3 Step approach.
- description
- Standard 3 Step approach of the WHO analgesic ladder (Step 1 - Step 2 - Step 3).
- interventionNames
- Other: analgesic ladder
- type
- EXPERIMENTAL
- label
- 2 Step approach.
- description
- 2 Step approach of the WHO analgesic ladder (Step 1 - Step 3).
- interventionNames
- Other: analgesic ladder
Primary outcomes (1)
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available