Cancer PainNCT02856399
Long-term Effects of Methadone for Cancer Pain
An observational study of Cancer Pain, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The methadone is an useful opioid for the cancer pain treatment, mostly used in second or last line during the opioid rotation. The Methadone had an anti-MNDA effect, and clinicians agree that the methadone could have an effect in neuropathic cancer pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Pain
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2014to Aug 2018
- 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: Patients undergoing a methadone treatment for cancer pain
Who may be able to join
- Patients with t methadone for cancer pain in opioid rotation
- Able to fill the questionnaire
- Performance status (PS) from 0 to 2
Who cannot join
- Patients PS 3
- Unable to sign the informed consent
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Unité de Soins Palliatifs - Hospices Civils de Lyon - Centre Hospitalier Lyon Sud, 165 Chemin du Grand Revoyet
Pierre-Bénite, 69310
Marilene FILBET, Pr Associate, (0)478864148 ext. +33, marilene.filbet@chu-lyon.fr
About this study
The methadone is an useful opioid for the cancer pain treatment, mostly used in second or last line during the opioid rotation. The Methadone had an anti-MNDA effect, and clinicians agree that the methadone could have an effect in neuropathic cancer pain. During a previous study the investigators find that the pain was still improving after the week 2, but they had only a small number of patients still included at this stage and they cannot conclude.
The investigators decide to follow up systematically all the patients undergoing a methadone treatment for cancer pain, at day 28, to study the hypothesis about the long-term pain improvement.
- Conditions
- Cancer Pain
- Keywords
- methadone, cancer pain, long term effect
- Medical subject headings
- Cancer Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between EVA pain score at Day 28 and Day 0
long-term effects of methadone for cancer pain
Measured: pain score measure at Day 0 and Day 28
Secondary outcomes (4)
Change in score of neuropathic pain intensity NPSI
Measured: Day 0 and Day 28
Change in depression and anxiety score HADS
Measured: Day 0 and Day 28
Change in quality of life score QOL C30
Measured: Day 0 and Day 28
Side effect record
Measured: up to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startNov 2014
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marilene FILBET, Pr Associate, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02856399
- Sponsor's protocol ID
- 69HCL16_0523
- Status last verified
- Aug 2016
- First submitted
- 2 Aug 2016
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effects of Methadone for Cancer Pain
- ClinicalTrials.gov ID
- NCT02856399
- Acronym / sponsor ID
- 69HCL16_0523
- Conditions
- Cancer Pain
- Keywords
- methadone, cancer pain, long term effect
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 4 Aug 2016 (estimated)
- 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.
The methadone is an useful opioid for the cancer pain treatment, mostly used in second or last line during the opioid rotation. The Methadone had an anti-MNDA effect, and clinicians agree that the methadone could have an effect in neuropathic cancer pain. During a previous study the investigators find that the pain was still improving after the week 2, but they had only a small number of patients still included at this stage and they cannot conclude.
The investigators decide to follow up systematically all the patients undergoing a methadone treatment for cancer pain, at day 28, to study the hypothesis about the long-term pain improvement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing a methadone treatment for cancer pain
Key inclusion criteria (3 listed)
- Patients with t methadone for cancer pain in opioid rotation
- Able to fill the questionnaire
- Performance status (PS) from 0 to 2
Key exclusion criteria (2 listed)
- Patients PS 3
- Unable to sign the informed consent
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
Difference between EVA pain score at Day 28 and Day 0
Time frame: pain score measure at Day 0 and Day 28
long-term effects of methadone for cancer pain
4 secondary outcomes
Change in score of neuropathic pain intensity NPSI
Time frame: Day 0 and Day 28
Change in depression and anxiety score HADS
Time frame: Day 0 and Day 28
Change in quality of life score QOL C30
Time frame: Day 0 and Day 28
Side effect record
Time frame: up to Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
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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.
Marilene FILBET, Pr Associate principal investigator
Hospices Civils de Lyon
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 Cancer Pain, run by Hospices Civils de Lyon 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 4 Aug 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marilene FILBET, Pr Associate ((0)478864148 ext. +33, marilene.filbet@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between EVA pain score at Day 28 and Day 0 (time frame: pain score measure at Day 0 and Day 28). 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 4 Aug 2016.