Hand-foot SyndromeDermLightNCT04979078
Photobiomodulation Therapy in the Management of Hand-foot Syndrome and Hand-foot Skin Reaction
A study testing Photobiomodulation therapy (PBMT) in people with Hand-foot Syndrome and Hand-foot Skin Reaction, run by Jessa Hospital at 2 sites in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand-foot Syndrome, Hand-foot Skin Reaction
- What is being tested?
- Photobiomodulation therapy (PBMT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesBelgium
- Study dates
- 12 Jan 2022to Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium2 sites, 2 recruiting
- Not yet recruiting
Hasselt University
Hasselt, Limburg, 3500
Jeroen Mebis, MD, PhD, Jeroen.mebis@uhasselt.be
Jolien Robijns, PhD, +32 11 33 72 29, jolien.robijns@uhasselt.be
- Recruiting
Jessa Ziekenhuis VZW
Hasselt, Limburg, 3500
Jeroen Mebis, MD, PhD, +32 11 33 72 21, Jeroen.mebis@jessazh.be
Jolien Robijns, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Hand-foot Syndrome, Hand-foot Skin Reaction
- Being tested
- Photobiomodulation therapy (PBMT)
- Keywords
- Dermatology, Oncology, Photobiomodulation, Skin toxicity, Hand-foot syndrome, Hand-foot skin reaction, Hand-foot skin toxicity, Supportive cancer care, Light therapy
- Medical subject headings
- Hand-Foot Syndrome, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation therapy (PBMT)Device
Patients will receive PBM on the sole of their feet and palms of their hands
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The experimental group receives 9 sessions of photobiomodulation therapy (3x/week for 3 weeks). Receives: Device: Photobiomodulation therapy (PBMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 2 weeks post-PBMT
Clinical photograph
A clinical photograph of the palm of patients' hands and sole of their feet
Measured: Baseline
Clinical photograph
A clinical photograph of the palm of patients' hands and sole of their feet
Measured: Session 3 of PBMT
Clinical photograph
A clinical photograph of the palm of patients' hands and sole of their feet
Measured: Session 6 of PBMT
Clinical photograph
A clinical photograph of the palm of patients' hands and sole of their feet
Measured: Final PBM session (session 9)
Clinical photograph
A clinical photograph of the palm of patients' hands and sole of their feet
Measured: 2 weeks post-PBMT
Secondary outcomes (17)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: Two weeks post-PBMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start12 Jan 2022
- Primary completionAug 2024 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand-foot SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hasselt University
- Responsible party
- Sponsor
- Investigators
- Jeroen Mebis, MD, PhD, Principal investigator, Head of Medical Oncology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979078
- Sponsor's protocol ID
- 2021/071
- Acronym
- DermLight
- Status last verified
- Jun 2023
- First submitted
- 16 Jul 2021
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of Photobiomodulation Therapy in the Management of Hand-foot Syndrome and Hand-foot Skin Reaction: A Single-arm Trial
- ClinicalTrials.gov ID
- NCT04979078
- Acronym / sponsor ID
- DermLight / 2021/071
- Conditions
- Hand-foot Syndrome, Hand-foot Skin Reaction
- Keywords
- Dermatology, Oncology, Photobiomodulation, Skin toxicity, Hand-foot syndrome, Hand-foot skin reaction, Hand-foot skin toxicity, Supportive cancer care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Collaborators
- Hasselt University
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 27 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Photobiomodulation therapy (PBMT)The experimental group receives 9 sessions of photobiomodulation therapy (3x/week for 3 weeks). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photobiomodulation therapy (PBMT)Patients will receive PBM on the sole of their feet and palms of their hands | Device | Experimental group |
Primary outcome
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.
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.
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.
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.
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.
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
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
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
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
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
Clinical photograph
Time frame: Baseline
A clinical photograph of the palm of patients' hands and sole of their feet
Clinical photograph
Time frame: Session 3 of PBMT
A clinical photograph of the palm of patients' hands and sole of their feet
Clinical photograph
Time frame: Session 6 of PBMT
A clinical photograph of the palm of patients' hands and sole of their feet
Clinical photograph
Time frame: Final PBM session (session 9)
A clinical photograph of the palm of patients' hands and sole of their feet
Clinical photograph
Time frame: 2 weeks post-PBMT
A clinical photograph of the palm of patients' hands and sole of their feet
17 secondary outcomes
Patient subjective evaluation of skin reactions
Time frame: Baseline
Patient subjective evaluation of skin reactions
Time frame: Session 3 of PBMT
Patient subjective evaluation of skin reactions
Time frame: Session 6 of PBMT
Patient subjective evaluation of skin reactions
Time frame: Final PBM session (Session 9)
Patient subjective evaluation of skin reactions
Time frame: 2 weeks post-PBMT
Quality of life - DLQI
Time frame: Baseline
Quality of life - DLQI
Time frame: Session 3 of PBMT
Quality of life - DLQI
Time frame: Session 6 of PBMT
Quality of life - DLQI
Time frame: Final PBM session (session 9)
Quality of life - DLQI
Time frame: 2 weeks post-PBMT
Quality of life - Skindex-29
Time frame: Baseline
Quality of life - Skindex-29
Time frame: Session 3 of PBMT
Quality of life - Skindex-29
Time frame: Session 6 of PBMT
Quality of life - Skindex-29
Time frame: Final PBM session (session 9)
Quality of life - Skindex-29
Time frame: 2 weeks post-PBMT
Patients' satisfaction with the therapeutic intervention
Time frame: Final PBM session (session 9)
Patients' satisfaction with the therapeutic intervention
Time frame: Two weeks post-PBMT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeroen Mebis, MD, PhD principal investigator
Head of Medical Oncology Department
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation therapy (PBMT) in people with Hand-foot Syndrome and Hand-foot Skin Reaction, run by Jessa Hospital at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeroen Mebis, MD, PhD (+32 11 33 72 21, Jeroen.mebis@jessazh.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin reaction evaluation - CTCAE (time frame: Baseline). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.