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| Name | Class |
|---|---|
| Hasselt University | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | The experimental group receives 9 sessions of photobiomodulation therapy (3x/week for 3 weeks). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photobiomodulation therapy (PBMT) | Device | Patients will receive PBM on the sole of their feet and palms of their hands |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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) |
| 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 |
| 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 |
| Skin reaction evaluation - WHO |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeroen Mebis, MD, PhD | Contact | +32 11 33 72 21 | Jeroen.mebis@jessazh.be | |
| Jolien Robijns, PhD | Contact | +32 11 33 72 29 | jolien.robijns@uhasselt.be |
| Name | Affiliation | Role |
|---|---|---|
| Jeroen Mebis, MD, PhD | Head of Medical Oncology Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hasselt University | Not yet recruiting | Hasselt | Limburg | 3500 | Belgium |
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| ID | Term |
|---|---|
| D060831 | Hand-Foot Syndrome |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D003875 | Drug Eruptions |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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The severity of the skin reactions will be evaluated by the World Health Association (WHO) grading scale for HFS/HFSR
| 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 | 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 | 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 | 2 weeks post-PBMT |
| Clinical photograph | A clinical photograph of the palm of patients' hands and sole of their feet | Baseline |
| Clinical photograph | A clinical photograph of the palm of patients' hands and sole of their feet | Session 3 of PBMT |
| Clinical photograph | A clinical photograph of the palm of patients' hands and sole of their feet | Session 6 of PBMT |
| Clinical photograph | A clinical photograph of the palm of patients' hands and sole of their feet | Final PBM session (session 9) |
| Clinical photograph | A clinical photograph of the palm of patients' hands and sole of their feet | 2 weeks post-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) |
| 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) | 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) | 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) | 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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). | 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). | 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). | 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 | 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 | Two weeks post-PBMT |
| Baseline |
| 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) |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Appearance and date of secondary tumors | The possible appearance and date of secondary tumors will be collected. | 1 year follow-up post-PBMT |
| Appearance and date of secondary tumors | The possible appearance and date of secondary tumors will be collected. | 2 year follow-up post-PBMT |
| Appearance and date of secondary tumors | The possible appearance and date of secondary tumors will be collected. | 3 year follow-up post-PBMT |
| Appearance and date of secondary tumors | The possible appearance and date of secondary tumors will be collected. | 4 year follow-up post-PBMT |
| Appearance and date of secondary tumors | The possible appearance and date of secondary tumors will be collected. | 5 year follow-up post-PBMT |
| Appearance and date of distant metastasis | The possible appearance and date of distant metastasis will be collected. | 1 year follow-up post-PBMT |
| Appearance and date of distant metastasis | The possible appearance and date of distant metastasis will be collected. | 2 year follow-up post-PBMT |
| Appearance and date of distant metastasis | The possible appearance and date of distant metastasis will be collected. | 3 year follow-up post-PBMT |
| Appearance and date of distant metastasis | The possible appearance and date of distant metastasis will be collected. | 4 year follow-up post-PBMT |
| Appearance and date of distant metastasis | The possible appearance and date of distant metastasis will be collected. | 5 year follow-up post-PBMT |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Jessa Ziekenhuis VZW | Recruiting | Hasselt | Limburg | 3500 | Belgium |
|
| D004342 |
| Drug Hypersensitivity |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |