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

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Medical Conditions
  • Cancer
  • Pain
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Completed
Trial source and source ID number
Clinicaltrials.gov
NCT01493635
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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).
Research Details
    Sorry, this information is not available
Phase
N/A
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Other : analgesic ladder, Other : analgesic ladder

Study Arm Groups : Standard 3 Step approach., 2 Step approach.

Intervention Type
See Interventions above
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.; Up to 20 days
Secondary Outcome Measures
    Sorry, this information is not available
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
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Gender
All
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion 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.
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Edinburgh Cancer Centre at Western General Hospital
Edinburgh
Scotland
EH4 2XU
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific 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.
EudraCT Number
Not available for this trial
Funder(s)
  • NHS Lothian
Other Study ID Numbers
11/SS/0079
Sponsor(s)
University of Edinburgh
Key Dates
Recruitment Start Date

Nov 2012

Recruitment End Date

Mar 2016

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

15 Dec 2011

Date updated in source

16 May 2017