Lymphedema Therapy With Sound Wave Lymphatic Drainage
Efficacy of Low Frequency Sound Waves in the Treatment of Breast Cancer Related Lymphedema: a Cross-over Randomized Trial
1 other identifier
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 30, 2010
CompletedFirst Posted
Study publicly available on registry
May 4, 2010
CompletedFebruary 4, 2016
February 1, 2016
1.2 years
March 30, 2010
February 3, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Volume of lymphedema
Evaluation of the lymphedema volume measuring size of the extremity affected
2 months
Secondary Outcomes (2)
Pain
2 months
Quality of life
2 months
Study Arms (2)
manual lymphatic drainage
ACTIVE COMPARATORApplication of manual lymphatic drainage
low frequency sound waves
EXPERIMENTALApplication of low frequency sound waves
Interventions
Application of manual lymphatic drainage (one session every work day during two weeks, total 10 sessions)
Application of low frequency sound waves (one session every work day during two weeks, total 10 sessions)
Eligibility Criteria
You may qualify if:
- Lymphedema presence at least for 1 year
- No previous treatments for lymphedema in the last 6 months
You may not qualify if:
- Electronic devices or metalic implants
- Cardiac failure or hypertension
- Epilepsy
- Local infection
- Pregnancy
- Thrombophlebitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fundacion IMIMlead
Study Sites (1)
Hospital de la Esperanza
Barcelona, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roser Belmonte, MD
Hospital de la Esperanza, Barcelona, Spain
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
March 30, 2010
First Posted
May 4, 2010
Study Start
May 1, 2008
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
February 4, 2016
Record last verified: 2016-02