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NCT Number: NCT04979078

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

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.

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Key information

Conditions

Hand-foot Syndrome Chemically-Induced Disorders Dermatitis Drug Eruptions Drug Hypersensitivity Drug-Related Side Effects and Adverse Reactions Hand-foot Skin Reaction Neoplasms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hasselt University, Hasselt, Limburg, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Photobiomodulation therapy (PBMT)

Device

Patients will receive PBM on the sole of their feet and palms of their hands

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jeroen Mebis, MD, PhD

CONTACT

[email protected]

+32 11 33 72 21

Jolien Robijns, PhD

CONTACT

[email protected]

+32 11 33 72 29

Sponsors and collaborators

Lead sponsor

Jessa Hospital

Other

Collaborators

  • Hasselt University

Registry information

Official study title

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

Acronym: DermLight

Important dates

Study start
2022
Primary completion
2024
Study completion
2029
First posted
Jul 27, 2021
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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