Actively Recruiting
Photobiomodulation Therapy in the Management of Hand-foot Syndrome and Hand-foot Skin Reaction
Led by Jessa Hospital · Updated on 2023-06-18
40
Participants Needed
2
Research Sites
394 weeks
Total Duration
On this page
Sponsors
J
Jessa Hospital
Lead Sponsor
H
Hasselt University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Photobiomodulation Therapy in the Management of Hand-foot Syndrome and Hand-foot Skin Reaction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with cancer of different aetiologies
- Undergoing chemotherapy or targeted therapy (TKIs)
- Diagnosed with HFS or HFSR grade 1, 2, or 3 (NCI-CTCAE v5)
- Age 18 years or older
- Able to comply with the study protocol
- Able to sign written informed consent
You will not qualify if you...
- Pre-existing skin rash, ulceration, or open wound in treatment areas (hand, foot)
- Known allergy to polyurethane
- Substance abuse or medical, psychological, or social conditions interfering with participation or evaluation
- Any unstable condition affecting safety or compliance as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Hasselt University
Hasselt, Limburg, Belgium, 3500
Not Yet Recruiting
2
Jessa Ziekenhuis VZW
Hasselt, Limburg, Belgium, 3500
Actively Recruiting
Research Team
J
Jeroen Mebis, MD, PhD
CONTACT
J
Jolien Robijns, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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