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

NCT ID: NCT01493635

Last Updated: 2017-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2016-03-31

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).

Conditions

Cancer; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard 3 Step approach.

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

Group Type: ACTIVE_COMPARATOR

analgesic ladder

Intervention Type: OTHER

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

2 Step approach.

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

Group Type: EXPERIMENTAL

analgesic ladder

Intervention Type: OTHER

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.

Interventions

analgesic ladder

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

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NHS Lothian

OTHER_GOV

Sponsor Role: collaborator

University of Edinburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie Fallon

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Locations

Western General Hospital

Edinburgh, , United Kingdom

Countries

United Kingdom

Other Identifiers

11/SS/0079

Identifier Type: -

Identifier Source: org_study_id