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

Primary Purpose

Cancer, Pain

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
analgesic ladder
analgesic ladder
Sponsored by
University of Edinburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Western General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard 3 Step approach.

2 Step approach.

Arm Description

Standard 3 Step approach of the WHO analgesic ladder (Step 1 - Step 2 - Step 3).

2 Step approach of the WHO analgesic ladder (Step 1 - Step 3).

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
December 15, 2011
Last Updated
May 16, 2017
Sponsor
University of Edinburgh
Collaborators
NHS Lothian
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1. Study Identification

Unique Protocol Identification Number
NCT01493635
Brief Title
Two Step Versus the Standard Three Step Approach of the WHO Analgesic Ladder for Cancer Pain Relief.
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Edinburgh
Collaborators
NHS Lothian

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard 3 Step approach.
Arm Type
Active Comparator
Arm Description
Standard 3 Step approach of the WHO analgesic ladder (Step 1 - Step 2 - Step 3).
Arm Title
2 Step approach.
Arm Type
Experimental
Arm Description
2 Step approach of the WHO analgesic ladder (Step 1 - Step 3).
Intervention Type
Other
Intervention Name(s)
analgesic ladder
Intervention Description
Patients will be managed according to the standard 3 Step approach of the WHO analgesic ladder (Step 1 - Step 2 - Step 3).
Intervention Type
Other
Intervention Name(s)
analgesic ladder
Intervention Description
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Fallon
Organizational Affiliation
University of Edinburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western General Hospital
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom

12. IPD Sharing Statement

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

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