Hand-foot Syndrome, Hand-foot Skin Reaction
Conditions
Keywords
Dermatology, Oncology, Photobiomodulation, Skin toxicity, Hand-foot syndrome, Hand-foot skin reaction, Hand-foot skin toxicity, Supportive cancer care, Light therapy
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.
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.
Interventions
Patients will receive PBM on the sole of their feet and palms of their hands
Sponsors
Hasselt University
Jessa Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin reaction evaluation - CTCAE | 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. |
| Clinical photograph | Baseline | A clinical photograph of the palm of patients' hands and sole of their feet |
| Skin reaction evaluation - WHO | Baseline | The severity of the skin reactions will be evaluated by the World Health Association (WHO) grading scale for HFS/HFSR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life - DLQI | Baseline | Dermatology Life Quality Index (DLQI) is a questionnaire with 10 items and is used to measure QoL of dermatological patients. |
| Patient subjective evaluation of skin reactions | 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) |
| Quality of life - Skindex-29 | 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). |
| Patients' satisfaction with the therapeutic intervention | Final PBM session (session 9) | The patients will be asked to evaluate their satisfaction with PBM on a 5-point Likert scale |
Other
| Measure | Time frame | Description |
|---|---|---|
| Appearance and date of secondary tumors | 1 year follow-up post-PBMT | The possible appearance and date of secondary tumors will be collected. |
| Appearance and date of local and regional recurrence | 1 year follow-up post-PBMT | The possible appearance and date of local and/or regional recurrence will be collected. |
| Date of death of any cause | 1 year follow-up post-PBMT | If the patient dies within the first year after the treatment, their date of death will be collected. |
| Appearance and date of distant metastasis | 1 year follow-up post-PBMT | The possible appearance and date of distant metastasis will be collected. |
| General patient-, disease-, and treatment-related information | 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). |
Countries
Belgium
Contacts
Primary ContactJeroen Mebis, MD, PhD
Backup ContactJolien Robijns, PhD
Outcome results
None listed