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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01493635
Recruitment Status : Completed
First Posted : December 16, 2011
Last Update Posted : May 17, 2017
NHS Lothian
Information provided by (Responsible Party):
University of Edinburgh

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).

Condition or disease Intervention/treatment Phase
Cancer Pain Other: analgesic ladder Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
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.
Study Start Date : November 2012
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: University of Edinburgh Identifier: NCT01493635     History of Changes
Other Study ID Numbers: 11/SS/0079
First Posted: December 16, 2011    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: December 2015

Additional relevant MeSH terms:
Cancer Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs