NCT02473744

Brief Summary

  • Background : Edema of lower extremities is a concern ranging from 19 % to 60% of palliative cancer patients. Lymphedema decreases mobility, induces pain, impacts daily activities, esthetic and behavior. Usual treatment is based on diuretics and physiotherapy but is often unsuccessful. In case of conventional treatment failure, in palliative care, subcutaneous drainage can be discussed with the patients. The technique is simple, easy to use but remains off the record. Since 2004, 23 cases were reported with various methods. All the cases reported were undertaken with various technical approaches and efficacy criteria.
  • Purpose : Investigator hypothesize that the subcutaneous drainage of edema (SDO) is effective in case of refractory lymphedema of the lower limbs in palliative care and leads to an improvement in QOL in terms of behavioral and autonomy.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 17, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

July 27, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2017

Completed
Last Updated

November 14, 2017

Status Verified

November 1, 2017

Enrollment Period

2 years

First QC Date

June 8, 2015

Last Update Submit

November 9, 2017

Conditions

Edema

Keywords

lower limb edemasubcutaneous drainagebioelectrical impedancequality of life

Outcome Measures

Primary Outcomes (1)

  • Karnofsky's scale

    Change in autonomy evaluated by Karnofsky's scale between Day 7 and Day 0

    7 days

Secondary Outcomes (8)

  • Karnofsky's scale

    4 Days

  • The 15th item of the European Organisation for Research and Treatment of Cancer quality of life questionnaires of palliative cancer care patients (EORTC QLQ C15 PAL),

    4 days and 7 days

  • Modify Dermatology Life Quality Index (MDLQI)

    4 days and 7 days

  • Verbal numeric scale for pain

    4 days and 7 days

  • Bioelectrical impedance analysis of lower limbs, calves and thighs

    4 days and 7 days

  • +3 more secondary outcomes

Study Arms (1)

Oedematous lower limb subcutaneous drainage

EXPERIMENTAL

In case of lymphoedema in palliative situation, a subcutaneous drainage can be performed. It is a simple method, easy to use. After topic analgesia, three subcutaneous channels are created and an absorbent pad collects the lymphatic fluid.

Other: subcutaneous drainage

Interventions

subcutaneous drainageOTHER

After topic analgesia, three subcutaneous channels are created and an absorbent pad collects the lymphatic fluid.

Oedematous lower limb subcutaneous drainage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18
  • palliative care patients
  • Karnofsky Scale \< 50%
  • Uni or bilateral lower limb oedema even if associated with lumbar or pelvi-scrotal oedema or ascitis whatever etiology involved (cancer, organ failure, hypoalbuminemia…)
  • Effective Social security regimen affiliation
  • Signed informed consent

You may not qualify if:

  • Refusal to take part in the study
  • Local anesthesic contraindication
  • Infected skin lesions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University hospital

Bordeaux, 33000, France

Location

University hospital

Limoges, 87042, France

Location

University hospital

Nantes, 40031, France

Location

Hospital

Périgueux, 24019, France

Location

Joseph Ducuing hospital

Toulouse, 31027, France

Location

University hospital

Toulouse, 31059, France

Location

Hospital

Valenciennes, 59300, France

Location

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bertrand SARDIN, MD

    University Hospital, Limoges

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 8, 2015

First Posted

June 17, 2015

Study Start

July 27, 2015

Primary Completion

July 20, 2017

Study Completion

July 20, 2017

Last Updated

November 14, 2017

Record last verified: 2017-11

Locations

FR(7)