Photobiomodulation Therapy in the Management of Hand-foot Syndrome and Hand-foot Skin Reaction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Photobiomodulation therapy (PBMT).
- Who it may be relevant to
- Registry conditions: Hand-foot Syndrome, Hand-foot Skin Reaction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluating the Effectiveness of Photobiomodulation Therapy in the Management of Hand-foot Syndrome and Hand-foot Skin Reaction: A Single-arm Trial
Overview
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.
Detailed description
The aim of this study is to evaluate the efficacy of PBMT in the management of HFS and HFSR in patients with cancer treated with chemotherapy or TKIs up to 2 weeks post-PBMT.
Primary objective: The study seeks primarily to determine the effectiveness of PBMT in reducing the severity of HFS and HFSR in patients with cancer of different etiology undergoing chemotherapy or TKIs, diagnosed with HFS or HFSR (grade 1-3).
Secondary objective 1 : HFS/HFSR-related symptoms
A secondary aim of this study is to evaluate if PBMT and can reduce the HFS/HSFR-related symptoms during PBM treatment and up to 2 weeks post-PBMT
Secondary Objective 2: Quality of life
A secondary aim of this study is to evaluate if PBMT can improve the patients' QoL during PBM treatment and up to 2 weeks post-PBMT
Secondary Objective 3: Patient satisfaction
A secondary aim of this study is to evaluate if patients are satisfied with PBMT as a treatment for HFS and HFSR during the treatment sessions and up to 2 weeks post-PBMT
Secondary Objective 4: PBM safety
A secondary aim of this study is to evaluate the safety of PBM in oncologic patients up to 5 years post-PBMT.
Interventions
- Device Photobiomodulation therapy (PBMT)
Patients will receive PBM on the sole of their feet and palms of their hands
Primary outcome measures
- Skin reaction evaluation - CTCAE [Time frame: Baseline]
- Skin reaction evaluation - CTCAE [Time frame: Session 3 of PBMT]
- Skin reaction evaluation - CTCAE [Time frame: Session 6 of PBMT]
- Skin reaction evaluation - CTCAE [Time frame: Final PBM session (session 9)]
- Skin reaction evaluation - CTCAE [Time frame: 2 weeks post-PBMT]
- Skin reaction evaluation - WHO [Time frame: Baseline]
- Skin reaction evaluation - WHO [Time frame: Session 3 of PBMT]
- Skin reaction evaluation - WHO [Time frame: Session 6 of PBMT]
- Skin reaction evaluation - WHO [Time frame: Final PBM session (session 9)]
- Skin reaction evaluation - WHO [Time frame: 2 weeks post-PBMT]
Secondary outcome measures (12)
- Patient subjective evaluation of skin reactions [Time frame: Baseline]
- Patient subjective evaluation of skin reactions [Time frame: Session 3 of PBMT]
- Patient subjective evaluation of skin reactions [Time frame: Session 6 of PBMT]
- Patient subjective evaluation of skin reactions [Time frame: Final PBM session (Session 9)]
- Patient subjective evaluation of skin reactions [Time frame: 2 weeks post-PBMT]
- Quality of life - DLQI [Time frame: Baseline]
- Quality of life - DLQI [Time frame: Session 3 of PBMT]
- Quality of life - DLQI [Time frame: Session 6 of PBMT]
- Quality of life - DLQI [Time frame: Final PBM session (session 9)]
- Quality of life - DLQI [Time frame: 2 weeks post-PBMT]
- Quality of life - Skindex-29 [Time frame: Baseline]
- Quality of life - Skindex-29 [Time frame: Session 3 of PBMT]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Belgium · 2 centers
- Hasselt University — Hasselt
- Jessa Ziekenhuis VZW — Hasselt
Identifiers
NCT: NCT04979078 · 2021/071