Comfort Subcutaneous Drainage: a Descriptive Study Among Palliative Phase Cancer Patients
Primary Purpose
Lymphedema
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
subcutaneous drainage
Sponsored by
About this trial
This is an interventional treatment trial for Lymphedema
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Lost-of-sight or transferred to another hospital subjects
- Subjects wishing to end their participation before study ending
Sites / Locations
- CALRecruiting
- Centre Hospitalier
- Centre Hospitalier Universitaire de NiceRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
subcutaneous drainage
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02494115
First Posted
June 26, 2015
Last Updated
September 26, 2016
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT02494115
Brief Title
Comfort Subcutaneous Drainage: a Descriptive Study Among Palliative Phase Cancer Patients
Official Title
Comfort Subcutaneous Drainage: a Descriptive Study Among Palliative Care Cancer Patients Presenting Severe Refractory Lower Limbs Lymphedema
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
January 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
subcutaneous drainage
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
subcutaneous drainage
Primary Outcome Measure Information:
Title
evolution of the patient's discomfort due to his oedemas
Description
It will be measured with a numeric scale from 0 no discomfort to 10 maximal discomfort.
Time Frame
on the 3rd day after lymphcentesis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Lost-of-sight or transferred to another hospital subjects
Subjects wishing to end their participation before study ending
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Flora TREMELLAT, MD
Email
tremellat.f@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Flora TREMELLAT, MD
Organizational Affiliation
tremellat.f@chu-nice.fr
Official's Role
Principal Investigator
Facility Information:
Facility Name
CAL
City
Nice
State/Province
Alpes-maritimes
ZIP/Postal Code
06001
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CIAIS Catherine, MD
First Name & Middle Initial & Last Name & Degree
CIAIS Catherine, MD
Facility Name
Centre Hospitalier
City
Avignon
ZIP/Postal Code
84902
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mireille PERINEAU-CASALS, PH
Facility Name
Centre Hospitalier Universitaire de Nice
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flora TREMELLAT, MD
12. IPD Sharing Statement
Learn more about this trial
Comfort Subcutaneous Drainage: a Descriptive Study Among Palliative Phase Cancer Patients
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