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

Pain Clinical Trial

— TVT  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01493635
• Other study ID #: 11/SS/0079
• Status: Completed
• Phase: N/A
• First received: December 15, 2011
• Last updated: May 16, 2017
• Start date: November 2012
• Est. completion date: March 2016

Study information

• Verified date: December 2015
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Pain

Intervention

Other:
• analgesic ladder
Patients will be managed according to the standard 3 Step approach of the WHO analgesic ladder (Step 1 - Step 2 - Step 3).
• analgesic ladder
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.

Locations

Country	Name	City	State
United Kingdom	Western General Hospital	Edinburgh

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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