Intrathecal Analgesia Effects on Cancer Patients Discomfort Symptoms (IT-ESAS)

July 28, 2020 updated by: University Hospital, Montpellier

Evaluation of Discomfort Symptoms in Patients With Refractory Cancer Pain and Intrathecal Analgesia Management

Intrathecal analgesia is used in refractory cancer pain because of drug sides effects or intractable pain. The aim of this approach is to improve pain management, and also to improve patient comfort. This study will assess patient discomfort symptoms before and after setting up intrathecal analgesia.

Study Overview

Status

Completed

Conditions

Detailed Description

Descriptive multicenter study including patients with refractory cancer pain (unmanageable drug sides effects or intractable pain) who will receive intrathecal analgesia Patient discomfort symptoms will be evaluated before and after the beginning of intrathecal analgesia at 15, 30, 60 and 90 days.

Moreover, the impact on patient close relatives and on return home will be assessed.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Uhmontpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

cancer patients with refractory localized cancer pain because of drug side effects or intractable pain who will receive intrathecal analgesia.

Description

Inclusion criteria:

  • patients aged 18 and older
  • obligation of affiliation or beneficiary of a social security scheme
  • patients with cancer and refractory localized cancer pain because of drug side effects or intractable pain
  • localized pain in topography accessible to intrathecal analgesia (legs, abdomen and pelvis, pancoast-tobias symdrom)
  • patient's informed consent for the study
  • patient able to complete the evaluation questionnaires
  • estimed vital prognosis more than three month
  • patient with all conditions for intrathecal anagelsia

Exclusion criteria:

  • patient with intracranial hypertension
  • refusal of patient to be included in the study
  • refusal of patient to receive intrathecal analgesia
  • patient with many refractory pain localizations not accessible to intrathecal analgesia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number Evaluation of Edmonton symptoms
Time Frame: up to 90 days after patient inclusion
Edmonton symptom assessment system
up to 90 days after patient inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Autonomy assessment score for activities of daily living
Time Frame: 1 day
Autonomy assessment score for activities of daily living
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Collaborators

Centre Hospitalier Universitaire de Nīmes
Institut du Cancer de Montpellier
Oncopole Toulouse

Investigators

  • Principal Investigator: Raphael RENAMBATZ-ICHAMBE, University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Actual)

April 30, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

March 11, 2020

First Submitted That Met QC Criteria

July 28, 2020

First Posted (Actual)

July 29, 2020

Study Record Updates

Last Update Posted (Actual)

July 29, 2020

Last Update Submitted That Met QC Criteria

July 28, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL19_0065

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

NC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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