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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Belgium
Hasselt University
RECRUITING
Hasselt
Jessa Ziekenhuis
RECRUITING
Hasselt
Contact Information
Primary
Jolien Robijns, PhD
jolien.robijns@jessazh.be
011337229
Time Frame
Start Date: 2021-02-22
Estimated Completion Date: 2028-02
Participants
Target number of participants: 104
Treatments
Experimental: Group A
Group A will receive first PBM + manual lymphatic drainage for 9 weeks (2 sessions/week), followed by 9 weeks only manual lymphatic drainage.
Active_comparator: Group B
Group B will first receive only manual lymphatic drainage for 9 weeks, followed by the combination of PBM and manual lymphatic drainage for 9 weeks (2x/week).
Related Therapeutic Areas
Breast Cancer
Lymphedema
Sponsors
Collaborators: Hasselt University
Leads: Jessa Hospital

This content was sourced from clinicaltrials.gov

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