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

• ClinicalTrials.gov Identifier: NCT04979078
• Recruitment Status: Recruiting
• First Posted: July 27, 2021
• Last Update Posted: February 15, 2022
• Sponsor: Jessa Hospital
• Collaborator: Hasselt University
• Information provided by (Responsible Party): Jessa Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hand-foot Syndrome; Hand-foot Skin Reaction	Device: Photobiomodulation therapy (PBMT)	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluating the Effectiveness of Photobiomodulation Therapy in the Management of Hand-foot Syndrome and Hand-foot Skin Reaction: A Single-arm Trial
• Actual Study Start Date: January 12, 2022
• Estimated Primary Completion Date: March 2023
• Estimated Study Completion Date: March 2028

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Skin reaction evaluation - CTCAE [ Time Frame: Baseline ]
   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. Skin reaction evaluation - CTCAE [ Time Frame: Session 3 of PBMT ]
   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.
3. Skin reaction evaluation - CTCAE [ Time Frame: Session 6 of PBMT ]
   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.
4. Skin reaction evaluation - CTCAE [ Time Frame: Final PBM session (session 9) ]
   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.
5. Skin reaction evaluation - CTCAE [ Time Frame: 2 weeks post-PBMT ]
   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.
6. Skin reaction evaluation - WHO [ Time Frame: Baseline ]
   The severity of the skin reactions will be evaluated by the World Health Association (WHO) grading scale for HFS/HFSR
7. Skin reaction evaluation - WHO [ Time Frame: Session 3 of PBMT ]
   The severity of the skin reactions will be evaluated by the World Health Association (WHO) grading scale for HFS/HFSR
8. Skin reaction evaluation - WHO [ Time Frame: Session 6 of PBMT ]
   The severity of the skin reactions will be evaluated by the World Health Association (WHO) grading scale for HFS/HFSR
9. Skin reaction evaluation - WHO [ Time Frame: Final PBM session (session 9) ]
   The severity of the skin reactions will be evaluated by the World Health Association (WHO) grading scale for HFS/HFSR
10. Skin reaction evaluation - WHO [ Time Frame: 2 weeks post-PBMT ]
    The severity of the skin reactions will be evaluated by the World Health Association (WHO) grading scale for HFS/HFSR
11. Clinical photograph [ Time Frame: Baseline ]
    A clinical photograph of the palm of patients' hands and sole of their feet
12. Clinical photograph [ Time Frame: Session 3 of PBMT ]
    A clinical photograph of the palm of patients' hands and sole of their feet
13. Clinical photograph [ Time Frame: Session 6 of PBMT ]
    A clinical photograph of the palm of patients' hands and sole of their feet
14. Clinical photograph [ Time Frame: Final PBM session (session 9) ]
    A clinical photograph of the palm of patients' hands and sole of their feet
15. Clinical photograph [ Time Frame: 2 weeks post-PBMT ]
    A clinical photograph of the palm of patients' hands and sole of their feet

Secondary Outcome Measures :

1. Patient subjective evaluation of skin reactions [ Time Frame: Baseline ]
   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. Patient subjective evaluation of skin reactions [ Time Frame: Session 3 of PBMT ]
   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)
3. Patient subjective evaluation of skin reactions [ Time Frame: Session 6 of PBMT ]
   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)
4. Patient subjective evaluation of skin reactions [ Time Frame: Final PBM session (Session 9) ]
   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)
5. Patient subjective evaluation of skin reactions [ Time Frame: 2 weeks post-PBMT ]
   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)
6. Quality of life - DLQI [ Time Frame: Baseline ]
   Dermatology Life Quality Index (DLQI) is a questionnaire with 10 items and is used to measure QoL of dermatological patients.
7. Quality of life - DLQI [ Time Frame: Session 3 of PBMT ]
   Dermatology Life Quality Index (DLQI) is a questionnaire with 10 items and is used to measure QoL of dermatological patients.
8. Quality of life - DLQI [ Time Frame: Session 6 of PBMT ]
   Dermatology Life Quality Index (DLQI) is a questionnaire with 10 items and is used to measure QoL of dermatological patients.
9. Quality of life - DLQI [ Time Frame: Final PBM session (session 9) ]
   Dermatology Life Quality Index (DLQI) is a questionnaire with 10 items and is used to measure QoL of dermatological patients.
10. Quality of life - DLQI [ Time Frame: 2 weeks post-PBMT ]
    Dermatology Life Quality Index (DLQI) is a questionnaire with 10 items and is used to measure QoL of dermatological patients.
11. Quality of life - Skindex-29 [ Time Frame: Baseline ]
    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).
12. Quality of life - Skindex-29 [ Time Frame: Session 3 of PBMT ]
    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).
13. Quality of life - Skindex-29 [ Time Frame: Session 6 of PBMT ]
    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).
14. Quality of life - Skindex-29 [ Time Frame: Final PBM session (session 9) ]
    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).
15. Quality of life - Skindex-29 [ Time Frame: 2 weeks post-PBMT ]
    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).
16. Patients' satisfaction with the therapeutic intervention [ Time Frame: Final PBM session (session 9) ]
    The patients will be asked to evaluate their satisfaction with PBM on a 5-point Likert scale
17. Patients' satisfaction with the therapeutic intervention [ Time Frame: Two weeks post-PBMT ]
    The patients will be asked to evaluate their satisfaction with PBM on a 5-point Likert scale

Other Outcome Measures:

1. General patient-, disease-, and treatment-related information [ Time Frame: Baseline ]
   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. General patient-, disease-, and treatment-related information [ Time Frame: Final PBM session (session 9) ]
   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).
3. General patient-, disease-, and treatment-related information [ Time Frame: 2 weeks post-PBMT ]
   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).
4. Appearance and date of local and regional recurrence [ Time Frame: 1 year follow-up post-PBMT ]
   The possible appearance and date of local and/or regional recurrence will be collected.
5. Appearance and date of local and regional recurrence [ Time Frame: 2 year follow-up post-PBMT ]
   The possible appearance and date of local and/or regional recurrence will be collected.
6. Appearance and date of local and regional recurrence [ Time Frame: 3 year follow-up post-PBMT ]
   The possible appearance and date of local and/or regional recurrence will be collected.
7. Appearance and date of local and regional recurrence [ Time Frame: 4 year follow-up post-PBMT ]
   The possible appearance and date of local and/or regional recurrence will be collected.
8. Appearance and date of local and regional recurrence [ Time Frame: 5 year follow-up post-PBMT ]
   The possible appearance and date of local and/or regional recurrence will be collected.
9. Appearance and date of secondary tumors [ Time Frame: 1 year follow-up post-PBMT ]
   The possible appearance and date of secondary tumors will be collected.
10. Appearance and date of secondary tumors [ Time Frame: 2 year follow-up post-PBMT ]
    The possible appearance and date of secondary tumors will be collected.
11. Appearance and date of secondary tumors [ Time Frame: 3 year follow-up post-PBMT ]
    The possible appearance and date of secondary tumors will be collected.
12. Appearance and date of secondary tumors [ Time Frame: 4 year follow-up post-PBMT ]
    The possible appearance and date of secondary tumors will be collected.
13. Appearance and date of secondary tumors [ Time Frame: 5 year follow-up post-PBMT ]
    The possible appearance and date of secondary tumors will be collected.
14. Appearance and date of distant metastasis [ Time Frame: 1 year follow-up post-PBMT ]
    The possible appearance and date of distant metastasis will be collected.
15. Appearance and date of distant metastasis [ Time Frame: 2 year follow-up post-PBMT ]
    The possible appearance and date of distant metastasis will be collected.
16. Appearance and date of distant metastasis [ Time Frame: 3 year follow-up post-PBMT ]
    The possible appearance and date of distant metastasis will be collected.
17. Appearance and date of distant metastasis [ Time Frame: 4 year follow-up post-PBMT ]
    The possible appearance and date of distant metastasis will be collected.
18. Appearance and date of distant metastasis [ Time Frame: 5 year follow-up post-PBMT ]
    The possible appearance and date of distant metastasis will be collected.
19. Date of death of any cause [ Time Frame: 1 year follow-up post-PBMT ]
    If the patient dies within the first year after the treatment, their date of death will be collected.
20. Date of death of any cause [ Time Frame: 2 year follow-up post-PBMT ]
    If the patient dies within 2 years after the treatment, their date of death will be collected.
21. Date of death of any cause [ Time Frame: 3 year follow-up post-PBMT ]
    If the patient dies within 3 years after the treatment, their date of death will be collected.
22. Date of death of any cause [ Time Frame: 4 year follow-up post-PBMT ]
    If the patient dies within 4 years after the treatment, their date of death will be collected.
23. Date of death of any cause [ Time Frame: 5 year follow-up post-PBMT ]
    If the patient dies within 5 years after the treatment, their date of death will be collected.

Eligibility Criteria

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

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

Contacts and Locations

Contacts

Contact: Jeroen Mebis, MD, PhD; +32 11 33 72 21; Jeroen.mebis@jessazh.be

Contact: Jolien Robijns, PhD; +32 11 33 72 29; jolien.robijns@uhasselt.be

Locations

Belgium

Hasselt University; Not yet recruiting

Hasselt, Limburg, Belgium, 3500

Contact: Jeroen Mebis, MD, PhD Jeroen.mebis@uhasselt.be

Contact: Jolien Robijns, PhD +32 11 33 72 29 jolien.robijns@uhasselt.be

Jessa Ziekenhuis VZW; Recruiting

Hasselt, Limburg, Belgium, 3500

Contact: Jeroen Mebis, MD, PhD +32 11 33 72 21 Jeroen.mebis@jessazh.be

Sub-Investigator: Jolien Robijns, PhD

Sponsors and Collaborators

Jessa Hospital

Hasselt University

Investigators

• Principal Investigator: Jeroen Mebis, MD, PhD; Head of Medical Oncology Department

More Information

Additional Information:

Website of the Limburg Oncologic Laser Institute 

• Responsible Party: Jessa Hospital
• ClinicalTrials.gov Identifier: NCT04979078
• Other Study ID Numbers: 2021/071
• First Posted: July 27, 2021
• Last Update Posted: February 15, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jessa Hospital:

Dermatology; Oncology; Photobiomodulation; Skin toxicity; Hand-foot syndrome; Hand-foot skin reaction; Hand-foot skin toxicity; Supportive cancer care; Light therapy

Additional relevant MeSH terms:

Hand-Foot Syndrome; Syndrome; Disease; Pathologic Processes; Drug Eruptions; Dermatitis; Skin Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders