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

NCT02494115 | Completed DMC

• 1 other identifier: 14-PP12
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

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.

Conditions

Lymphedema

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Procedure: subcutaneous drainage

Interventions

subcutaneous drainage PROCEDURE

subcutaneous drainage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Lost-of-sight or transferred to another hospital subjects
• Subjects wishing to end their participation before study ending

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (3)

CAL

Nice, Alpes-maritimes, 06001, France

Location

Centre Hospitalier

Avignon, 84902, France

Location

Centre Hospitalier Universitaire de Nice

Nice, 06000, France

Location

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Flora TREMELLAT, MD

  tremellat.f@chu-nice.fr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2015
• First Posted: July 10, 2015
• Study Start: January 6, 2016
• Primary Completion: September 15, 2018
• Study Completion: September 15, 2018
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

FR (3)