Pneumatic compression versus manual lymph drainage as part of decongestive care for breast cancer–related lymphedema
Comparison of Intermittent Pneumatic Compression Therapy as an Alternative or an Adjunct to Manual Lymphatic Drainage Within Complete Decongestive Therapy for Breast Cancer-Related Lymphedema
This study tests whether adding or replacing manual lymph drainage with intermittent pneumatic compression helps women with unilateral breast cancer–related arm lymphedema.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Pamukkale University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Denizli) |
| Trial ID | NCT07154043 on ClinicalTrials.gov |
What this trial studies
Participants with unilateral breast cancer–related upper extremity lymphedema receive complete decongestive therapy (CDT) delivered in different ways: standard CDT including manual lymph drainage (MLD), CDT plus intermittent pneumatic compression (IPC), or CDT with IPC instead of MLD. Eligible women are adults (18–65) with at least six months of unilateral lymphedema meeting >20% limb volume or >2 cm circumference difference after mastectomy and axillary dissection. Outcomes include changes in limb volume and circumference, symptoms such as heaviness and tension, upper limb function, and quality of life measured before and after the treatment period. The trial aims to clarify whether IPC can be a useful adjunct or alternative to MLD within routine CDT.
Who should consider this trial
Good fit: Women aged 18–65 with unilateral breast cancer–related arm lymphedema for at least six months, with >20% limb volume difference or >2 cm circumference difference, who completed primary breast cancer treatment at least six months ago and have not had recent lymphedema therapy are ideal candidates.
Not a fit: Patients with bilateral lymphedema, bilateral axillary dissection, metastatic or active cancer, stage 3 lymphedema, ongoing radiotherapy/chemotherapy, or uncontrolled serious systemic disease are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If effective, IPC could offer an alternative or complementary option to manual lymph drainage that reduces swelling and improves arm comfort and function.
How similar studies have performed: Previous trials comparing IPC and MLD have reported inconsistent results—some found no difference while others noted benefits of IPC for heaviness—so evidence to date is mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female gender * Patients aged 18-65 years * Having a history of unilateral mastectomy and lymph node dissection at least one year ago due to breast cancer diagnosis. * Having unilateral breast cancer-related upper extremity lymphedema (\>20% volume difference between the two upper extremities or \>2 cm difference in circumference at any measured point) according to the diagnostic criteria of the International Society of Lymphology (Committee 2023) for at least six months. * Not having received lymphedema treatment or exercise therapy for the last six months * Completing breast cancer primary treatment at least 6 months ago (except hormone therapy/aromatase inhibitors) Exclusion Criteria: * Bilateral breast cancer * Bilateral axillary lymph node dissection * Metastatic breast cancer * Receiving ongoing radiotherapy or chemotherapy * Primary or bilateral lymphedema * Having active cancer * Presence of stage 3 lymphedema * Uncontrolled serious systemic disease (cardiopulmonary diseases, arterial or venous diseases, renal dysfunction, uncontrolled hypertension or hypotension, cardiac arrhythmia, scleroderma, Sudek's atrophy). * Current or recent (within the last 3 months) infection (cellulitis, lymphangitis) or deep venous thrombosis * Presence of open wounds * Using medications that may affect body fluid and electrolyte balance (diuretics, etc.). * Individuals with serious mental and sensory problems * Being pregnant * Body mass index \>40 kg/m2
Where this trial is running
Denizli
- Pamukkale University — Denizli, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Emre Bezmez, M.D.
- Email: emrebezmez@gmail.com
- Phone: +905319902220
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.