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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Patients will receive PBM on the sole of their feet and palms of their hands
Hasselt University
Hasselt, Limburg, Belgium
NOT_YET_RECRUITINGJessa Ziekenhuis VZW
Hasselt, Limburg, Belgium
RECRUITINGSkin reaction evaluation - CTCAE
The severity of the skin reactions will be evaluated by the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5.
Time frame: Baseline
Skin reaction evaluation - CTCAE
The severity of the skin reactions will be evaluated by the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5.
Time frame: Session 3 of PBMT
Skin reaction evaluation - CTCAE
The severity of the skin reactions will be evaluated by the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5.
Time frame: Session 6 of PBMT
Skin reaction evaluation - CTCAE
The severity of the skin reactions will be evaluated by the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5.
Time frame: Final PBM session (session 9)
Skin reaction evaluation - CTCAE
The severity of the skin reactions will be evaluated by the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5.
Time frame: 2 weeks post-PBMT
Skin reaction evaluation - WHO
The severity of the skin reactions will be evaluated by the World Health Association (WHO) grading scale for HFS/HFSR
Time frame: Baseline
Skin reaction evaluation - WHO
The severity of the skin reactions will be evaluated by the World Health Association (WHO) grading scale for HFS/HFSR
Time frame: Session 3 of PBMT
Skin reaction evaluation - WHO
The severity of the skin reactions will be evaluated by the World Health Association (WHO) grading scale for HFS/HFSR
Time frame: Session 6 of PBMT
Skin reaction evaluation - WHO
The severity of the skin reactions will be evaluated by the World Health Association (WHO) grading scale for HFS/HFSR
Time frame: Final PBM session (session 9)
Skin reaction evaluation - WHO
The severity of the skin reactions will be evaluated by the World Health Association (WHO) grading scale for HFS/HFSR
Time frame: 2 weeks post-PBMT
Clinical photograph
A clinical photograph of the palm of patients' hands and sole of their feet
Time frame: Baseline
Clinical photograph
A clinical photograph of the palm of patients' hands and sole of their feet
Time frame: Session 3 of PBMT
Clinical photograph
A clinical photograph of the palm of patients' hands and sole of their feet
Time frame: Session 6 of PBMT
Clinical photograph
A clinical photograph of the palm of patients' hands and sole of their feet
Time frame: Final PBM session (session 9)
Clinical photograph
A clinical photograph of the palm of patients' hands and sole of their feet
Time frame: 2 weeks post-PBMT
Patient subjective evaluation of skin reactions
The patients will be asked to complete a questionnaire to evaluate the intensity of eight common symptoms of HFS/HFSR: pruritus, dryness, erythema, burning sensation, oedema, desquamation, blistering, and pain on an 11-point Numerical Rating Scale (NRS)
Time frame: Baseline
Patient subjective evaluation of skin reactions
The patients will be asked to complete a questionnaire to evaluate the intensity of eight common symptoms of HFS/HFSR: pruritus, dryness, erythema, burning sensation, oedema, desquamation, blistering, and pain on an 11-point Numerical Rating Scale (NRS)
Time frame: Session 3 of PBMT
Patient subjective evaluation of skin reactions
The patients will be asked to complete a questionnaire to evaluate the intensity of eight common symptoms of HFS/HFSR: pruritus, dryness, erythema, burning sensation, oedema, desquamation, blistering, and pain on an 11-point Numerical Rating Scale (NRS)
Time frame: Session 6 of PBMT
Patient subjective evaluation of skin reactions
The patients will be asked to complete a questionnaire to evaluate the intensity of eight common symptoms of HFS/HFSR: pruritus, dryness, erythema, burning sensation, oedema, desquamation, blistering, and pain on an 11-point Numerical Rating Scale (NRS)
Time frame: Final PBM session (Session 9)
Patient subjective evaluation of skin reactions
The patients will be asked to complete a questionnaire to evaluate the intensity of eight common symptoms of HFS/HFSR: pruritus, dryness, erythema, burning sensation, oedema, desquamation, blistering, and pain on an 11-point Numerical Rating Scale (NRS)
Time frame: 2 weeks post-PBMT
Quality of life - DLQI
Dermatology Life Quality Index (DLQI) is a questionnaire with 10 items and is used to measure QoL of dermatological patients.
Time frame: Baseline
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Quality of life - DLQI
Dermatology Life Quality Index (DLQI) is a questionnaire with 10 items and is used to measure QoL of dermatological patients.
Time frame: Session 3 of PBMT
Quality of life - DLQI
Dermatology Life Quality Index (DLQI) is a questionnaire with 10 items and is used to measure QoL of dermatological patients.
Time frame: Session 6 of PBMT
Quality of life - DLQI
Dermatology Life Quality Index (DLQI) is a questionnaire with 10 items and is used to measure QoL of dermatological patients.
Time frame: Final PBM session (session 9)
Quality of life - DLQI
Dermatology Life Quality Index (DLQI) is a questionnaire with 10 items and is used to measure QoL of dermatological patients.
Time frame: 2 weeks post-PBMT
Quality of life - Skindex-29
The skindex-29 is a validated instrument to measures patients' QoL specifically correlated with skin conditions. It has 3 scales addressing emotions (10 items), symptoms (7 items) and functioning (12 items).
Time frame: Baseline
Quality of life - Skindex-29
The skindex-29 is a validated instrument to measures patients' QoL specifically correlated with skin conditions. It has 3 scales addressing emotions (10 items), symptoms (7 items) and functioning (12 items).
Time frame: Session 3 of PBMT
Quality of life - Skindex-29
The skindex-29 is a validated instrument to measures patients' QoL specifically correlated with skin conditions. It has 3 scales addressing emotions (10 items), symptoms (7 items) and functioning (12 items).
Time frame: Session 6 of PBMT
Quality of life - Skindex-29
The skindex-29 is a validated instrument to measures patients' QoL specifically correlated with skin conditions. It has 3 scales addressing emotions (10 items), symptoms (7 items) and functioning (12 items).
Time frame: Final PBM session (session 9)
Quality of life - Skindex-29
The skindex-29 is a validated instrument to measures patients' QoL specifically correlated with skin conditions. It has 3 scales addressing emotions (10 items), symptoms (7 items) and functioning (12 items).
Time frame: 2 weeks post-PBMT
Patients' satisfaction with the therapeutic intervention
The patients will be asked to evaluate their satisfaction with PBM on a 5-point Likert scale
Time frame: Final PBM session (session 9)
Patients' satisfaction with the therapeutic intervention
The patients will be asked to evaluate their satisfaction with PBM on a 5-point Likert scale
Time frame: Two weeks post-PBMT