Comfort Subcutaneous Drainage: a Descriptive Study Among Palliative Phase Cancer Patients

Not Applicable

Completed

• Conditions: Lymphedema
• Interventions: Procedure: subcutaneous drainage

• Registration Number: NCT02494115
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Study Timeline

• Study First Submitted: 2015-06-26
• Study First Submitted QC: 2015-07-07
• Study First Posted: 2015-07-10
• Study Start: 2016-01-06
• Primary Completion: 2018-09-15
• Study Completion: 2018-09-15
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
subcutaneous drainage	subcutaneous drainage	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.

Primary Outcome Measures

Name	Time	Method
evolution of the patient's discomfort due to his oedemas	on the 3rd day after lymphcentesis	It will be measured with a numeric scale from 0 no discomfort to 10 maximal discomfort.

Trial Locations

Locations (3)

CAL; 🇫🇷 Nice, Alpes-maritimes, France

Centre Hospitalier; 🇫🇷 Avignon, France

Centre Hospitalier Universitaire de Nice; 🇫🇷 Nice, France