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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2011 by University of Edinburgh
Sponsor:
Collaborator:
NHS Lothian
Information provided by (Responsible Party):
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT01493635
First received: December 15, 2011
Last updated: NA
Last verified: November 2011
History: No changes posted
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 450
Study Start Date: March 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01493635

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

No publications provided

Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT01493635     History of Changes
Other Study ID Numbers: 11/SS/0079
Study First Received: December 15, 2011
Last Updated: December 15, 2011
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014