RecruitingNot ApplicableNCT04690439

Photobiomodulation Therapy for the Management of Breast Cancer-related Lymphedema

Evaluating the Effectiveness of Photobiomodulation Therapy in the Management of Breast Cancer-Related Lymphedema: a Randomized Controlled Trial

Sponsor

Jessa Hospital

Enrollment

104 participants

Start Date

Feb 22, 2021

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Lymphedema of Upper Arm Breast Cancer Related Lymphedema

Summary

Up to one out of five patients with breast cancer will develop lymphedema in the upper extremity after cancer treatment. Patients with breast cancer-related lymphedema (BCRL) suffer from pain, heaviness, tightness, and a decreased range of motion. Photobiomodulation therapy (PBMT) is a non-invasive therapy based on the application of visible and/or near-infrared light produced by a laser diode or a light-emitting diode. The scientifically proven biologic effects of PBM are improved wound healing, and a reduction in pain, inflammation, and oedema. Therefore, the aim of this study is to evaluate the effectiveness of PBMT on the management of BCRL.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria7

Diagnosed with breast cancer
Underwent ipsilateral lumpectomy or mastectomy + sentinel lymph node biopsy +/- lymph node dissection
Underwent radiotherapy with or without chemotherapy
Diagnosed with BCRL (i.e. International Society of Lymphology (ISL) lymphedema stage I or higher)
Age ≥ 18 years
Able to comply to the study protocol
Able to sign written informed consent

Exclusion Criteria7

Metastatic disease
Pregnancy
History of surgery or trauma to the arm
History of arm infection in the past 3 months
Use of medications that affect body fluid (e.g., diuretics) in the last 3 months
Severe psychological disorder or dementia
Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator