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

This study has been completed.
NHS Lothian
Information provided by (Responsible Party):
University of Edinburgh Identifier:
First received: December 15, 2011
Last updated: May 16, 2017
Last verified: December 2015
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).

Condition Intervention
Cancer Pain Other: analgesic ladder

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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.

Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • 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. [ Time Frame: Up to 20 days ]

Enrollment: 152
Study Start Date: November 2012
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard 3 Step approach.
Standard 3 Step approach of the WHO analgesic ladder (Step 1 - Step 2 - Step 3).
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).
Experimental: 2 Step approach.
2 Step approach of the WHO analgesic ladder (Step 1 - Step 3).
Other: 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01493635

United Kingdom
Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
Principal Investigator: Marie Fallon University of Edinburgh
  More Information

Responsible Party: University of Edinburgh Identifier: NCT01493635     History of Changes
Other Study ID Numbers: 11/SS/0079
Study First Received: December 15, 2011
Last Updated: May 16, 2017

Additional relevant MeSH terms:
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs processed this record on September 21, 2017