Clinical Trial

Photobiomodulation Therapy in the Management of Hand-foot Syndrome and Hand-foot Skin Reaction

Study acronym: DermLight
Recruiting
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Record status
This record was last updated June 18, 2023 (before its estimated August 2024 completion). Its status may not reflect the trial's current state.
Summary
Hand-foot syndrome (HFS) is a side effect of chemotherapy. HFS is characterized by redness, swelling, and pain on the palms of the hands and/or soles of the feet, which can progress to blistering. Hand-foot skin reaction (HFSR) refers to symptoms affecting the hands and/or feet associated with multikinase inhibitors (TKIs). HFS and HFSR are painful complications that can lead to compromised daily activities, sleep-wake disturbance and impaired mobility, eventually decreasing Quality of Life (QoL). 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. The aim of this study is to evaluate the effectiveness of PBMT in the management of HFS and HFSR.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2021-07-16; most recent amendment 2023-06-15.
Status change: Not Yet Recruiting → Recruiting 2022-02-14
Trial Details
NCT Number NCT04979078
Lead Sponsor Jessa Hospital
Collaborators: Hasselt University
Conditions Hand-foot Syndrome, Hand-foot Skin Reaction
Enrollment 40 participants
Start Date 2022-01-12
Primary Completion 2024-08 (estimated)
Study Completion 2029-08 (estimated)
Updated on ClinicalTrials.gov 2023-06-18