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

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).

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Key information

Conditions

Cancer Neoplasms Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

analgesic ladder

Other

Patients will be managed according to the standard 3 Step approach of the WHO analgesic ladder (Step 1 - Step 2 - Step 3).

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

NHS Lothian

Registry information

Official study 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.

Acronym: TVT

Important dates

Study start: 2012
Primary completion: 2016
Study completion: 2016
First posted: Dec 16, 2011
Registry last updated: May 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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