Status:

NOT_YET_RECRUITING

Comparison of IPC Therapy as an Alternative or an Adjunct to MLD Within CDT for BCRL

Lead Sponsor:

Pamukkale University

Conditions:

Breast Cancer-Related Lymphedema

BCRL

Eligibility:

FEMALE

18-65 years

Phase:

NA

Brief Summary

Breast cancer is the most common cancer among women worldwide and lymphedema is one of its most significant complications. Breast cancer-related lymphedema (BCRL) may develop shortly after treatment o...

Detailed Description

Breast cancer is the most common malignancy among women worldwide and remains the leading cause of cancer-related mortality in women. Breast cancer-related lymphedema (BCRL) is one of the most importa...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

September 15 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2026

Estimated Enrollment :

45 Patients enrolled

Trial Details

Trial ID

NCT07154043

Start Date

September 15 2025

End Date

December 1 2026

Last Update

September 4 2025

Active Locations (1)

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1

Pamukkale University

Denizli, Turkey (Türkiye)

Comparison of IPC Therapy as an Alternative or an Adjunct to MLD Within CDT for BCRL | DecenTrialz