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

NCT01493635 | Completed

• 1 other identifier: 11/SS/0079
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 20 days

Study Arms (2)

Standard 3 Step approach.

ACTIVE COMPARATOR

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

Other: analgesic ladder

2 Step approach.

EXPERIMENTAL

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

Other: analgesic ladder

Interventions

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).

Standard 3 Step approach.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator

Study Sites (1)

Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marie Fallon

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2011
• First Posted: December 16, 2011
• Study Start: November 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 17, 2017

Record last verified: 2015-12

Locations

GB (1)