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

RecruitingNAAges 18 Years - anyAllJessa Hospital
NCT04979078 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Diagnosed with cancer of different aetiologies * Undergoing chemotherapy or targeted therapy (TKIs) * Diagnosed with HFS-HFSR grade 1, 2 or 3 (National Cancer Institute - Common Terminology Criteria for Adverse Events, NCI-CTCAE v5) * Age ≥ 18 years * Able to comply to the study protocol * Able to sign written informed consent Exclusion Criteria: * Pre-existing skin rash, ulceration or open wound in the treatment area (hand, foot) * Known allergy to polyurethane * Substance abuse patients or patients with medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results as judged by the investigator * Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator
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What it tests

  • Photobiomodulation therapy (PBMT)
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Where

2 sites
Hasselt University
Hasselt, Belgium
Jessa Ziekenhuis VZW
Hasselt, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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