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Treatment of breast cancer-associated lymphedema. A randomized study of the (cost-)effectiveness of manual lymphatic drainage and/or intermittent pneumatic compression

Treatment of breast cancer-associated lymphedema. A randomized study of the (cost-)effectiveness of manual lymphatic drainage and/or intermittent pneumatic compression - Evaluation of treatment of breast cancer-associated lymphedema.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON30736
Enrollment
207
Registered
2007-07-17
Start date
2007-01-01
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

Lymphedema

Interventions

Manual lymphatic drainage (MLD) is performed 3 times a week during 30 minutes, completed by multilayered compression bandages. It is performed by certified edema therapists, according to the Dr. Vod

Sponsors

Academisch Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Untreated lymphedema in one arm, developed after treatment for breast cancer. An increase in the volume of the affected arm >= 20% compared with the non-affected arm. Lymphedema developed >= 12 weeks after surgical treatment for breast cancer (axillary lymph node dissection and/or axillary radiation included).

Exclusion criteria

Exclusion criteria: Bilateral lymphedema. Breast cancer recurrence. Active clinical infection. Deep venous thrombosis. Pre-existent lymphedema.

Design outcomes

Primary

MeasureTime frame
The primary outcome measure will be percentage reduction in the excess limb volume. The normal limb acts as the patient*s own control. Inverse water volumetry (gold standard for measuring limb volume) will be used to quantify limb volume.

Secondary

MeasureTime frame
Health care costs will be measured and evaluated. For this we refer to the HTA-methodology study. The quality of life will be measured by means of two validated instruments at the time of enrolment, after completing the treatment, and at 6 months after inclusion: functional assessment of cancer therapy (FACTB) with the FACTB Plus 4 subscale, and the EuroQol-50.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)