Photobiomodulation Therapy in the Management of Hand-foot Syndrome and Hand-foot Skin Reaction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJessa Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Photobiomodulation therapy (PBMT)
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Jessa Hospital
Lead sponsor
Hasselt University
Collaborator
Source ClinicalTrials.gov