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OpenTrials
Completed

NCT Number: NCT01115374

Lymphedema Therapy With Sound Wave Lymphatic Drainage

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de la Esperanza

Barcelona, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manual Lymphatic Drainage

Procedure

Application of manual lymphatic drainage (one session every work day during two weeks, total 10 sessions)

Other names: Decongestive physiotherapy

low frequency sound waves

Device

Application of low frequency sound waves (one session every work day during two weeks, total 10 sessions)

Other names: Device based physiotherapy

Primary outcomes

  1. Volume of lymphedema

    Time frame: 2 months

    Evaluation of the lymphedema volume measuring size of the extremity affected

Secondary outcomes

  1. Pain

    Time frame: 2 months

    Visual Analog Scales of pain

  2. Quality of life

    Time frame: 2 months

    Quality of life using the Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer (FACT-B+4)

Sponsors and collaborators

Lead sponsor

Fundacion IMIM

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 4, 2010
Registry last updated
Feb 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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