Refractory Cancer PainIT-ESASNCT04491123
Intrathecal Analgesia Effects on Cancer Patients Discomfort Symptoms
An observational study of Refractory Cancer Pain and Intrathecal Analgesia, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Cancer Pain, Intrathecal Analgesia
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2018to 30 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: cancer patients with refractory localized cancer pain because of drug side effects or intractable pain who will receive intrathecal analgesia.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Refractory Cancer Pain, Intrathecal Analgesia
- Keywords
- Refractory cancer pain, intrathecal analgesia, pain management, discomfort symptoms management
- Medical subject headings
- Cancer Pain, Agnosia
What is being measured
The primary outcome is the main question the study is designed to answer.
Number Evaluation of Edmonton symptoms
Edmonton symptom assessment system
Measured: up to 90 days after patient inclusion
Secondary outcomes (1)
Autonomy assessment score for activities of daily living
Autonomy assessment score for activities of daily living
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start1 Nov 2018
- Primary completion30 Apr 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Cancer PainStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Institut du Cancer de Montpellier - Val d'Aurelle, Centre Hospitalier Universitaire de Nīmes, Oncopole Toulouse
- Responsible party
- Sponsor
- Investigators
- Raphael RENAMBATZ-ICHAMBE, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491123
- Sponsor's protocol ID
- RECHMPL19_0065
- Acronym
- IT-ESAS
- Status last verified
- Jul 2020
- First submitted
- 11 Mar 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Discomfort Symptoms in Patients With Refractory Cancer Pain and Intrathecal Analgesia Management
- ClinicalTrials.gov ID
- NCT04491123
- Acronym / sponsor ID
- IT-ESAS / RECHMPL19_0065
- Conditions
- Refractory Cancer Pain, Intrathecal Analgesia
- Keywords
- Refractory cancer pain, intrathecal analgesia, pain management, discomfort symptoms management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Institut du Cancer de Montpellier - Val d'Aurelle, Centre Hospitalier Universitaire de Nīmes, Oncopole Toulouse
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 29 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- cancer patients with refractory localized cancer pain because of drug side effects or intractable pain who will receive intrathecal analgesia.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number Evaluation of Edmonton symptoms
Time frame: up to 90 days after patient inclusion
Edmonton symptom assessment system
1 secondary outcome
Autonomy assessment score for activities of daily living
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Individual participant dataSharing planned: Undecided. NC
Related trials for Refractory Cancer Pain
Not yet recruitingPhase 1/2
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Psilocybin in Cancer Pain Study
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RecruitingObservational study
Dexmedetomidine for Refractory Pain in Palliative Cancer Patients
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Lidocaine Infusions for Pain in Patients With Malignant Bowel Obstruction
Malignant Bowel Obstruction, Cancer Pain
Active, not recruitingObservational study
Patients Referred to the Chronic Pain Unit for Palliative Treatment With Ozone Therapy Between 2022 and 2025
Radiation Toxicity, Chemotherapeutic Toxicity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raphael RENAMBATZ-ICHAMBE principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractory Cancer Pain and Intrathecal Analgesia, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number Evaluation of Edmonton symptoms (time frame: up to 90 days after patient inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.