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

Hand-foot Syndrome Clinical Trial

— DermLight  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04979078
• Other study ID #: 2021/071
• Status: Recruiting
• Phase: N/A
• Start date: January 12, 2022
• Est. completion date: August 2029

Study information

• Verified date: June 2023
• Source: Jessa Hospital
• Contact: Jeroen Mebis, MD, PhD
• Phone: +32 11 33 72 21
• Email: Jeroen.mebis[@]jessazh.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2029
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hand-foot Skin Reaction
• Hand-foot Syndrome
• Syndrome

Intervention

Device:
• Photobiomodulation therapy (PBMT)
Patients will receive PBM on the sole of their feet and palms of their hands

Locations

Country	Name	City	State
Belgium	Hasselt University	Hasselt	Limburg
Belgium	Jessa Ziekenhuis VZW	Hasselt	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Jessa Hospital	Hasselt University

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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)
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Appearance and date of secondary tumors	The possible appearance and date of secondary tumors will be collected.	1 year follow-up post-PBMT
Other	Appearance and date of secondary tumors	The possible appearance and date of secondary tumors will be collected.	2 year follow-up post-PBMT
Other	Appearance and date of secondary tumors	The possible appearance and date of secondary tumors will be collected.	3 year follow-up post-PBMT
Other	Appearance and date of secondary tumors	The possible appearance and date of secondary tumors will be collected.	4 year follow-up post-PBMT
Other	Appearance and date of secondary tumors	The possible appearance and date of secondary tumors will be collected.	5 year follow-up post-PBMT
Other	Appearance and date of distant metastasis	The possible appearance and date of distant metastasis will be collected.	1 year follow-up post-PBMT
Other	Appearance and date of distant metastasis	The possible appearance and date of distant metastasis will be collected.	2 year follow-up post-PBMT
Other	Appearance and date of distant metastasis	The possible appearance and date of distant metastasis will be collected.	3 year follow-up post-PBMT
Other	Appearance and date of distant metastasis	The possible appearance and date of distant metastasis will be collected.	4 year follow-up post-PBMT
Other	Appearance and date of distant metastasis	The possible appearance and date of distant metastasis will be collected.	5 year follow-up post-PBMT
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	Clinical photograph	A clinical photograph of the palm of patients' hands and sole of their feet	Baseline
Primary	Clinical photograph	A clinical photograph of the palm of patients' hands and sole of their feet	Session 3 of PBMT
Primary	Clinical photograph	A clinical photograph of the palm of patients' hands and sole of their feet	Session 6 of PBMT
Primary	Clinical photograph	A clinical photograph of the palm of patients' hands and sole of their feet	Final PBM session (session 9)
Primary	Clinical photograph	A clinical photograph of the palm of patients' hands and sole of their feet	2 weeks post-PBMT
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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

External Links

•   Website of the Limburg Oncologic Laser Institute