Has Manual Lymphatic Drainage (MLD), immediately applied after the axillary dissection during 5 months, a preventive effect on the development of arm lymphedema

Effectiveness of Manual Lymphatic Drainage (MLD) applied on patients treated for breast cancer: a randomised controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22079

Enrollment

160

Registered

2007-09-13

Start date

2007-10-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer, lymphedema, prevention, manual lymphatic drainage Borstkanker, lymfoedeem, preventie, manuele lymfedrainage

Interventions

1. In the periphery: not standardised

2. In our hospital: standardised

Control group: Exercises. Experimental group: Exercises + MLD. Exercises: The patient performs an exercise schema independently at home. The physiotherapist performs mobilisations of the shoulder an

Eligibility

Inclusion criteria

Inclusion criteria: Patients who had primary breast surgery with axillary dissection in the University Hospital Leuven (UZ Leuven).

Exclusion criteria

Exclusion criteria: 1. Patients who had breast surgery with sentinel procedure; 2. Patients with bilateral axillary dissection; 3. Patients not measured preoperatively; 4. Patients who refuse to participate in the study.

Design outcomes

Primary

Measure	Time frame
Incidence of arm lymphedema: defined by > 200 ml increase of the arm volume compared with the preoperative value. All patients from the control group and from the experimental group are measured first preoperatively and then 1 month, 3 months, 6 months, 1 year and 2 years after the breast surgery.	—

Secondary

Measure	Time frame
Functioning problems of the patients. At each measurement session the patient fills in the 'LYMF-SBP questionnaire'. This is a reliable and valid questionnaire that scores the consequences of an arm lymphedema in terms of 'International Classification of Functioning Disability and Health'. Shoulder mobility: anteflexion, abduction, functional exo- and endorotation (also each measurement session). Visible axillo-axillary anastomoses and visible rerouting of lymphatics from the arm to the trunk. Patients are asked to undergo a lymphoscintigraphic examination at the following points in time: before the start of the therapy, after 5 months of therapy and 6 months later. We want to include 20 patients in the experimental group and 20 patients in the control group.	—

Measure

Time frame

Functioning problems of the patients. At each measurement session the patient fills in the 'LYMF-SBP questionnaire'. This is a reliable and valid questionnaire that scores the consequences of an arm lymphedema in terms of 'International Classification of Functioning Disability and Health'. Shoulder mobility: anteflexion, abduction, functional exo- and endorotation (also each measurement session). Visible axillo-axillary anastomoses and visible rerouting of lymphatics from the arm to the trunk. Patients are asked to undergo a lymphoscintigraphic examination at the following points in time: before the start of the therapy, after 5 months of therapy and 6 months later. We want to include 20 patients in the experimental group and 20 patients in the control group.

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Contacts

Public ContactNele Devoogdt

UZ Leuven Dienst Fysische Geneeskunde en Revalidatie Herestraat 49

n.devoogdt@ha.be0032 (0) 16 348550

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)