Clinical trial NCT01115374: Lymphedema Therapy With Sound Wave Lymphatic Drainage
Official title: Efficacy of Low Frequency Sound Waves in the Treatment of Breast Cancer Related Lymphedema: a Cross-over Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema
Lead sponsor: Fundacion IMIM
Sponsor class: OTHER
First posted: 2010-05-04
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Volume of lymphedema
timeFrame: 2 months
Secondary outcomes:
measure: Pain
timeFrame: 2 months
measure: Quality of life
timeFrame: 2 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Esperanza
Study officials:
affiliation: Hospital de la Esperanza, Barcelona, Spain
name: Roser Belmonte, MD
role: PRINCIPAL_INVESTIGATOR
References: