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

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

Study Overview

• Status: Recruiting
• Conditions: Hand-foot Syndrome; Hand-foot Skin Reaction
• Intervention / Treatment: Device: Photobiomodulation therapy (PBMT)

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeroen Mebis, MD, PhD; Phone Number: +32 11 33 72 21; Email: Jeroen.mebis@jessazh.be
• Study Contact Backup: Name: Jolien Robijns, PhD; Phone Number: +32 11 33 72 29; Email: jolien.robijns@uhasselt.be

Study Locations

• Belgium
  • Limburg
    • Hasselt, Limburg, Belgium, 3500
      • Recruiting
      • Jessa Ziekenhuis VZW
      • Contact: Jeroen Mebis, MD, PhD; Phone Number: +32 11 33 72 21; Email: Jeroen.mebis@jessazh.be
      • Sub-Investigator: Jolien Robijns, PhD
    • Hasselt, Limburg, Belgium, 3500
      • Not yet recruiting
      • Hasselt University
      • Contact: Jolien Robijns, PhD; Phone Number: +32 11 33 72 29; Email: jolien.robijns@uhasselt.be
      • Contact: Jeroen Mebis, MD, PhD; Email: Jeroen.mebis@uhasselt.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
General patient-, disease-, and treatment-related information	General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (i.e., gender, age, smoking history, work habits, physical activity, skin condition, alcohol use, and medication use). Furthermore, information about disease- and treatment-related risk factors will be collected through medical records (e.g., tumor type and stage, tumor site, treatment type, etc).	Baseline
General patient-, disease-, and treatment-related information	General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (i.e., gender, age, smoking history, work habits, physical activity, skin condition, alcohol use, and medication use). Furthermore, information about disease- and treatment-related risk factors will be collected through medical records (e.g., tumor type and stage, tumor site, treatment type, etc).	Final PBM session (session 9)
General patient-, disease-, and treatment-related information	General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (i.e., gender, age, smoking history, work habits, physical activity, skin condition, alcohol use, and medication use). Furthermore, information about disease- and treatment-related risk factors will be collected through medical records (e.g., tumor type and stage, tumor site, treatment type, etc).	2 weeks post-PBMT
Appearance and date of local and regional recurrence	The possible appearance and date of local and/or regional recurrence will be collected.	1 year follow-up post-PBMT
Appearance and date of local and regional recurrence	The possible appearance and date of local and/or regional recurrence will be collected.	2 year follow-up post-PBMT
Appearance and date of local and regional recurrence	The possible appearance and date of local and/or regional recurrence will be collected.	3 year follow-up post-PBMT
Appearance and date of local and regional recurrence	The possible appearance and date of local and/or regional recurrence will be collected.	4 year follow-up post-PBMT
Appearance and date of local and regional recurrence	The possible appearance and date of local and/or regional recurrence will be collected.	5 year follow-up post-PBMT
Appearance and date of secondary tumors	The possible appearance and date of secondary tumors will be collected.	1 year follow-up post-PBMT
Appearance and date of secondary tumors	The possible appearance and date of secondary tumors will be collected.	2 year follow-up post-PBMT
Appearance and date of secondary tumors	The possible appearance and date of secondary tumors will be collected.	3 year follow-up post-PBMT
Appearance and date of secondary tumors	The possible appearance and date of secondary tumors will be collected.	4 year follow-up post-PBMT
Appearance and date of secondary tumors	The possible appearance and date of secondary tumors will be collected.	5 year follow-up post-PBMT
Appearance and date of distant metastasis	The possible appearance and date of distant metastasis will be collected.	1 year follow-up post-PBMT
Appearance and date of distant metastasis	The possible appearance and date of distant metastasis will be collected.	2 year follow-up post-PBMT
Appearance and date of distant metastasis	The possible appearance and date of distant metastasis will be collected.	3 year follow-up post-PBMT
Appearance and date of distant metastasis	The possible appearance and date of distant metastasis will be collected.	4 year follow-up post-PBMT
Appearance and date of distant metastasis	The possible appearance and date of distant metastasis will be collected.	5 year follow-up post-PBMT
Date of death of any cause	If the patient dies within the first year after the treatment, their date of death will be collected.	1 year follow-up post-PBMT
Date of death of any cause	If the patient dies within 2 years after the treatment, their date of death will be collected.	2 year follow-up post-PBMT
Date of death of any cause	If the patient dies within 3 years after the treatment, their date of death will be collected.	3 year follow-up post-PBMT
Date of death of any cause	If the patient dies within 4 years after the treatment, their date of death will be collected.	4 year follow-up post-PBMT
Date of death of any cause	If the patient dies within 5 years after the treatment, their date of death will be collected.	5 year follow-up post-PBMT

Collaborators and Investigators

• Sponsor: Jessa Hospital
• Collaborators: Hasselt University
• Investigators: Principal Investigator: Jeroen Mebis, MD, PhD, Head of Medical Oncology Department

Publications and helpful links

Helpful Links

• Website of the Limburg Oncologic Laser Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2022
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2029

Study Registration Dates

• First Submitted: July 16, 2021
• First Submitted That Met QC Criteria: July 16, 2021
• First Posted (Actual): July 27, 2021

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Oncology; Dermatology; Photobiomodulation; Supportive cancer care; Skin toxicity; Hand-foot syndrome; Light therapy; Hand-foot skin reaction; Hand-foot skin toxicity
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Skin Diseases; Disease; Dermatitis; Drug-Related Side Effects and Adverse Reactions; Drug Eruptions; Drug Hypersensitivity; Syndrome; Hand-Foot Syndrome
• Other Study ID Numbers: 2021/071

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No