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

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Evaluating the Effectiveness of Photobiomodulation Therapy in the Management of Hand-foot Syndrome and Hand-foot Skin Reaction: A Single-arm Trial

Conditions
-----------------
Hand-foot Syndrome, Hand-foot Skin Reaction

Intervention / Treatment
-----------------
* Device: Photobiomodulation therapy (PBMT)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>The experimental group receives 9 sessions of photobiomodulation therapy (3x/week for 3 weeks). | Device: Photobiomodulation therapy (PBMT)<br>* Patients will receive PBM on the sole of their feet and palms of their hands<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 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 | 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 | 2 weeks post-PBMT | 
| Clinical photograph | A clinical photograph of the palm of patients' hands and sole of their feet | Baseline | 
| Clinical photograph | A clinical photograph of the palm of patients' hands and sole of their feet | Session 3 of PBMT | 
| Clinical photograph | A clinical photograph of the palm of patients' hands and sole of their feet | Session 6 of PBMT | 
| Clinical photograph | A clinical photograph of the palm of patients' hands and sole of their feet | Final PBM session (session 9) | 
| Clinical photograph | A clinical photograph of the palm of patients' hands and sole of their feet | 2 weeks post-PBMT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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) | 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) | 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) | 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. | Baseline | 
| Quality of life - DLQI | Dermatology Life Quality Index (DLQI) is a questionnaire with 10 items and is used to measure QoL of dermatological patients. | 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. | 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. | 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. | 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). | 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). | 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). | 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). | 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). | 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 | 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 | Two weeks post-PBMT | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dermatology, Oncology, Photobiomodulation, Skin toxicity, Hand-foot syndrome, Hand-foot skin reaction, Hand-foot skin toxicity, Supportive cancer care, Light therapy