- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01493635
Two Step Versus the Standard Three Step Approach of the WHO Analgesic Ladder for Cancer Pain Relief. (TVT)
May 16, 2017 updated by: University of Edinburgh
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.
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).
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
152
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Edinburgh, United Kingdom, EH4 2XU
- Western General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard 3 Step approach.
Standard 3 Step approach of the WHO analgesic ladder (Step 1 - Step 2 - Step 3).
|
Patients will be managed according to the standard 3 Step approach of the WHO analgesic ladder (Step 1 - Step 2 - Step 3).
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.
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Experimental: 2 Step approach.
2 Step approach of the WHO analgesic ladder (Step 1 - Step 3).
|
Patients will be managed according to the standard 3 Step approach of the WHO analgesic ladder (Step 1 - Step 2 - Step 3).
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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.
Time Frame: Up to 20 days
|
Up to 20 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Marie Fallon, University of Edinburgh
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
December 15, 2011
First Submitted That Met QC Criteria
December 15, 2011
First Posted (Estimate)
December 16, 2011
Study Record Updates
Last Update Posted (Actual)
May 17, 2017
Last Update Submitted That Met QC Criteria
May 16, 2017
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11/SS/0079
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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