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


N/A
18 Years
N/A
Not Enrolling
Female
Lymphedema

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Outcome Measure:

Volume of lymphedema

Outcome Description:

Evaluation of the lymphedema volume measuring size of the extremity affected

Outcome Time Frame:

2 months

Safety Issue:

No

Principal Investigator

Roser Belmonte, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital de la Esperanza, Barcelona, Spain

Authority:

Spain: Comité Ético de Investigación Clínica

Study ID:

LES_OBSF_DLM

NCT ID:

NCT01115374

Start Date:

May 2008

Completion Date:

July 2009

Related Keywords:

  • Lymphedema
  • Lymphedema

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