LymphedemaNCT02494115
Comfort Subcutaneous Drainage: a Descriptive Study Among Palliative Phase Cancer Patients
A study testing subcutaneous drainage in people with Lymphedema, run by Centre Hospitalier Universitaire de Nice at 3 sites in France.
Trial summary
Physical embarrassment, pain and psychological impact linked to the body image distortion are often associated to these lymphedemas. Investigators decided to study new therapeutic method because of major discomfort due to these oedemas and doctors' difficulty to manage them. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphedema
- What is being tested?
- subcutaneous drainage
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesFrance
- Study dates
- 6 Jan 2016to 15 Sep 2018
- Phase
- Interventional
- 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
Who may be able to join
- Cancer patients
- Palliative care patients according to the SFAP (French Palliative care society) definition
- Patient taken care of in one of the palliative care structures implied in this project (palliative care unit, palliative care field team, hospital at home, palliative care day hospital)
- Patients presenting lower limb lymphedema resistant to traditional treatments or for whom these treatments are not adapted
- Lymphedema being a source of discomfort for the patient asking for relief
- Patient wishing a new treatment for lymphedema
- Patients with full cognitive capacities evaluated by the practitioner in charge of him
- Patients available during the study
Who cannot join
- Lost-of-sight or transferred to another hospital subjects
- Subjects wishing to end their participation before study ending
Trial locations and contacts
3 sites in 1 country.
France3 sites
Centre Hospitalier
Avignon, 84902
CAL
Nice, Alpes-maritimes, 06001
Centre Hospitalier Universitaire de Nice
Nice, 06000
About this study
Official title: Comfort Subcutaneous Drainage: a Descriptive Study Among Palliative Care Cancer Patients Presenting Severe Refractory Lower Limbs Lymphedema
Physical embarrassment, pain and psychological impact linked to the body image distortion are often associated to these lymphedemas. Investigators decided to study new therapeutic method because of major discomfort due to these oedemas and doctors' difficulty to manage them.
Subcutaneous drainage also called lymphocentesis seems to be an interesting technique. This local treatment consists in inserting in lower limbs several catheters draining into enclosed bags in order to evacuate lymph fluid and to lower local pressure.
Read more
Very few studies have been published concerning this technique and are presenting only a small number of cases. They cannot allow clear conclusions of this technique's efficiency but show encouraging results.
Investigators want to collect more data on this technique using a larger number of subjects in order to evaluate subcutaneous drainage effects on the comfort of palliative care cancer patients presenting lower limbs lymphedema. Investigators will consider as lymphedema, oedemas with no renal or cardiovascular identified cause and excluding anasarca.
Read the detailed description
Lower limbs lymphedemas are often reported in advanced palliative phase cancer patients. These oedemas have multiple causes and are complicated to be taken care of. Actual available treatments such as physiotherapist massage and compression stockings, are often lacking efficiency and are not adapted for these patients.
Physical embarrassment, pain and psychological impact linked to the body image distortion are often associated to these lymphedemas. Investigators decided to study new therapeutic method because of major discomfort due to these oedemas and doctors' difficulty to manage them.
Subcutaneous drainage also called lymphocentesis seems to be an interesting technique. This local treatment consists in inserting in lower limbs several catheters draining into enclosed bags in order to evacuate lymph fluid and to lower local pressure.
Very few studies have been published concerning this technique and are presenting only a small number of cases. They cannot allow clear conclusions of this technique's efficiency but show encouraging results.
Investigators want to collect more data on this technique using a larger number of subjects in order to evaluate subcutaneous drainage effects on the comfort of palliative care cancer patients presenting lower limbs lymphedema. Investigators will consider as lymphedema, oedemas with no renal or cardiovascular identified cause and excluding anasarca.
This study should be completed by a comparative randomized study to increase the evidence level if it shows a technical interest for drainage.
- Conditions
- Lymphedema
- Being tested
- subcutaneous drainage
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subcutaneous drainageProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| subcutaneous drainage | Experimental | This local treatment consists in inserting in lower limbs several catheters draining into enclosed bags in order to evacuate lymph fluid and to lower local pressure. Receives: Procedure: subcutaneous drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
evolution of the patient's discomfort due to his oedemas
It will be measured with a numeric scale from 0 no discomfort to 10 maximal discomfort.
Measured: on the 3rd day after lymphcentesis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study start6 Jan 2016
- Primary completion15 Sep 2018
- Study completion15 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Flora TREMELLAT, MD, Principal investigator, tremellat.f@chu-nice.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494115
- Sponsor's protocol ID
- 14-PP12
- Status last verified
- Nov 2023
- First submitted
- 26 Jun 2015
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comfort Subcutaneous Drainage: a Descriptive Study Among Palliative Care Cancer Patients Presenting Severe Refractory Lower Limbs Lymphedema
- ClinicalTrials.gov ID
- NCT02494115
- Acronym / sponsor ID
- 14-PP12
- Conditions
- Lymphedema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 6 Jan 2016 (actual)
- Primary completion
- 15 Sep 2018 (actual)
- Study completion
- 15 Sep 2018 (actual)
- First posted
- 10 Jul 2015 (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.
Physical embarrassment, pain and psychological impact linked to the body image distortion are often associated to these lymphedemas. Investigators decided to study new therapeutic method because of major discomfort due to these oedemas and doctors' difficulty to manage them.
Subcutaneous drainage also called lymphocentesis seems to be an interesting technique. This local treatment consists in inserting in lower limbs several catheters draining into enclosed bags in order to evacuate lymph fluid and to lower local pressure.
Very few studies have been published concerning this technique and are presenting only a small number of cases. They cannot allow clear conclusions of this technique's efficiency but show encouraging results.
Investigators want to collect more data on this technique using a larger number of subjects in order to evaluate subcutaneous drainage effects on the comfort of palliative care cancer patients presenting lower limbs lymphedema. Investigators will consider as lymphedema, oedemas with no renal or cardiovascular identified cause and excluding anasarca.
Detailed description
Lower limbs lymphedemas are often reported in advanced palliative phase cancer patients. These oedemas have multiple causes and are complicated to be taken care of. Actual available treatments such as physiotherapist massage and compression stockings, are often lacking efficiency and are not adapted for these patients.
Physical embarrassment, pain and psychological impact linked to the body image distortion are often associated to these lymphedemas. Investigators decided to study new therapeutic method because of major discomfort due to these oedemas and doctors' difficulty to manage them.
Subcutaneous drainage also called lymphocentesis seems to be an interesting technique. This local treatment consists in inserting in lower limbs several catheters draining into enclosed bags in order to evacuate lymph fluid and to lower local pressure.
Very few studies have been published concerning this technique and are presenting only a small number of cases. They cannot allow clear conclusions of this technique's efficiency but show encouraging results.
Investigators want to collect more data on this technique using a larger number of subjects in order to evaluate subcutaneous drainage effects on the comfort of palliative care cancer patients presenting lower limbs lymphedema. Investigators will consider as lymphedema, oedemas with no renal or cardiovascular identified cause and excluding anasarca.
This study should be completed by a comparative randomized study to increase the evidence level if it shows a technical interest for drainage.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subcutaneous drainage | Experimental | Procedure: subcutaneous drainageThis local treatment consists in inserting in lower limbs several catheters draining into enclosed bags in order to evacuate lymph fluid and to lower local pressure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Cancer patients
- Palliative care patients according to the SFAP (French Palliative care society) definition
- Patient taken care of in one of the palliative care structures implied in this project (palliative care unit, palliative care field team, hospital at home, palliative care day hospital)
- Patients presenting lower limb lymphedema resistant to traditional treatments or for whom these treatments are not adapted
- Lymphedema being a source of discomfort for the patient asking for relief
Key exclusion criteria (2 listed)
- Lost-of-sight or transferred to another hospital subjects
- Subjects wishing to end their participation before study ending
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| subcutaneous drainage | Procedure or surgery | subcutaneous drainage |
Primary outcome
evolution of the patient's discomfort due to his oedemas
Time frame: on the 3rd day after lymphcentesis
It will be measured with a numeric scale from 0 no discomfort to 10 maximal discomfort.
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 18 Nov 2023.
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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.
Flora TREMELLAT, MD principal investigator
tremellat.f@chu-nice.fr
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing subcutaneous drainage in people with Lymphedema, run by Centre Hospitalier Universitaire de Nice at 3 sites 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 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: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
evolution of the patient's discomfort due to his oedemas (time frame: on the 3rd day after lymphcentesis). 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 18 Nov 2023.