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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04979078
Recruitment Status : Recruiting
First Posted : July 27, 2021
Last Update Posted : February 15, 2022
Sponsor:
Collaborator:
Hasselt University
Information provided by (Responsible Party):
Jessa Hospital

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

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




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04979078


Contacts
Layout table for location 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
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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
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Principal Investigator: Jeroen Mebis, MD, PhD Head of Medical Oncology Department
Additional Information:
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Responsible Party: Jessa Hospital
ClinicalTrials.gov Identifier: NCT04979078    
Other Study ID Numbers: 2021/071
First Posted: July 27, 2021    Key Record Dates
Last Update Posted: February 15, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Layout table for 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