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

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.

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.

Study Overview

• Status: Completed
• Conditions: Lymphedema
• Intervention / Treatment: Procedure: subcutaneous drainage

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Avignon, France, 84902
    • Centre hospitalier
  • Nice, France, 06000
    • Centre Hospitalier Universitaire de Nice
  • Alpes-maritimes
    • Nice, Alpes-maritimes, France, 06001
      • CAL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: subcutaneous drainage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	on the 3rd day after lymphcentesis

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Flora TREMELLAT, MD, tremellat.f@chu-nice.fr

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2016
• Primary Completion (Actual): September 15, 2018
• Study Completion (Actual): September 15, 2018

Study Registration Dates

• First Submitted: June 26, 2015
• First Submitted That Met QC Criteria: July 7, 2015
• First Posted (Estimated): July 10, 2015

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: 14-PP12