Two Step Versus the Standard Three Step Approach of the WHO Analgesic Ladder for Cancer Pain Relief.

Study Overview
=================
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).

Official Title
-----------------
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.

Conditions
-----------------
Cancer, Pain

Intervention / Treatment
-----------------
* Other: analgesic ladder
* Other: analgesic ladder


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard 3 Step approach.<br>Standard 3 Step approach of the WHO analgesic ladder (Step 1 - Step 2 - Step 3). | Other: analgesic ladder<br>* Patients will be managed according to the standard 3 Step approach of the WHO analgesic ladder (Step 1 - Step 2 - Step 3).<br>|
| Experimental: 2 Step approach.<br>2 Step approach of the WHO analgesic ladder (Step 1 - Step 3). | Other: analgesic ladder<br>* Patients managed according to the WHO analgesic ladder bypassing Step 2, i.e. patients will move from Step 1 of the WHO analgesic ladder to Step 3.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |