Lymphedema Therapy With Sound Wave Lymphatic Drainage

Overview

Lymphedema is a frequent sequela of breast cancer treatment, that can develop up to 40% of patients. Lymphedema is the accumulation of protein-rich fluid (lymph) in the interstitial spaces of the affected body part due to a blockage or malfunction in the lymph system. It can appear in the arm, shoulder, breast, or thoracic area. Lymphedema swelling causes discomfort and sometimes disability. The treatment of lymphedema associated with breast cancer can include complex decongestive physiotherapy, compression therapy, therapeutic exercises, and pharmacotherapy.

In this study two treatments will be compared to reduce lymphedema: the manual lymphatic drainage (standard care) versus the low frequency sound waves.

Full Title of Study: “Efficacy of Low Frequency Sound Waves in the Treatment of Breast Cancer Related Lymphedema: a Cross-over Randomized Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: July 2009

Detailed Description

Lymphedema, a sequela of breast cancer and breast cancer therapy, changes functional abilities and may affect a patient's psychosocial adjustment and overall quality of life. Lymphedema is the accumulation of lymph fluid in the interstitial space. Fluid accumulation in the limbs causes enlargement, often with a feeling of heaviness.Chronic inflammation leads to fibrosis of the lymphatics, which compounds the problem. Several studies have examined the incidence of lymphedema when axillary radiation is given after axillary dissection vs radiation to an undissected axilla. The risk of lymphedema is higher in women treated with axillary dissection and adjuvant radiation to the axilla, with edema reported in 9% to 40% of patients. Patients with lymphedema may report symptoms such as a sensation of arm fullness and mild discomfort, which are seen in the early stages of the condition. Joint immobility, pain, and skin changes are noted frequently in the later stages of lymphedema. Patients also may be predisposed to infections involving the affected extremity. The treatment of lymphedema associated with breast cancer can include complex decongestive physiotherapy, compression therapy, therapeutic exercises, and pharmacotherapy. Manual lymphatic drainage is the standard decongestive therapy. Recently, low frequency sound waves has been used to reduce lymphedema. The aim of this study is to compare the efficacy of the manual lymphatic drainage versus the low frequency sound waves.

Interventions

  • Procedure: Manual lymphatic drainage
    • Application of manual lymphatic drainage (one session every work day during two weeks, total 10 sessions)
  • Device: low frequency sound waves
    • Application of low frequency sound waves (one session every work day during two weeks, total 10 sessions)

Arms, Groups and Cohorts

  • Active Comparator: manual lymphatic drainage
    • Application of manual lymphatic drainage
  • Experimental: low frequency sound waves
    • Application of low frequency sound waves

Clinical Trial Outcome Measures

Primary Measures

  • Volume of lymphedema
    • Time Frame: 2 months
    • Evaluation of the lymphedema volume measuring size of the extremity affected

Secondary Measures

  • Pain
    • Time Frame: 2 months
    • Visual Analog Scales of pain
  • Quality of life
    • Time Frame: 2 months
    • Quality of life using the Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer (FACT-B+4)

Participating in This Clinical Trial

Inclusion Criteria

  • Lymphedema presence at least for 1 year
  • No previous treatments for lymphedema in the last 6 months

Exclusion Criteria

  • Electronic devices or metalic implants
  • Cardiac failure or hypertension
  • Epilepsy
  • Local infection
  • Pregnancy
  • Thrombophlebitis

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fundacion IMIM
  • Provider of Information About this Clinical Study
    • Principal Investigator: Roser Belmonte, MD – Fundacion IMIM
  • Overall Official(s)
    • Roser Belmonte, MD, Principal Investigator, Hospital de la Esperanza, Barcelona, Spain

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