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Clinical Trials/NCT01115374
NCT01115374CompletedNot Applicable

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

Fundacion IMIM1 site in 1 country34 target enrollmentStarted: May 1, 2008Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
34
Locations
1
Primary Endpoint
Volume of lymphedema

Study Overview

Brief Summary

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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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
  • •Local infection
  • •Pregnancy
  • •Thrombophlebitis

Arms & Interventions

manual lymphatic drainage

Active Comparator

Application of manual lymphatic drainage

Intervention: Manual lymphatic drainage (Procedure)

low frequency sound waves

Experimental

Application of low frequency sound waves

Intervention: low frequency sound waves (Device)

Outcomes

Primary Outcomes

Volume of lymphedema

Time Frame: 2 months

Evaluation of the lymphedema volume measuring size of the extremity affected

Secondary Outcomes

  • Pain(2 months)
  • Quality of life(2 months)

Investigators

Sponsor
Fundacion IMIM
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Roser Belmonte

MD

Fundacion IMIM

Study Sites (1)

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