NCT04491123

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 29, 2020

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

1.5 years

First QC Date

March 11, 2020

Last Update Submit

July 28, 2020

Conditions

Refractory Cancer PainIntrathecal Analgesia

Keywords

Refractory cancer painintrathecal analgesiapain managementdiscomfort symptoms management

Outcome Measures

Primary Outcomes (1)

  • Number Evaluation of Edmonton symptoms

    Edmonton symptom assessment system

    up to 90 days after patient inclusion

Secondary Outcomes (1)

  • Autonomy assessment score for activities of daily living

    1 day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Cancer PainAgnosia

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • Raphael RENAMBATZ-ICHAMBE

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2020

First Posted

July 29, 2020

Study Start

November 1, 2018

Primary Completion

April 30, 2020

Study Completion

June 30, 2020

Last Updated

July 29, 2020

Record last verified: 2020-07

Locations

FR(1)