Photobiomodulation Therapy in the Management of Hand-foot Syndrome and Hand-foot Skin Reaction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJessa Hospital
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
Photobiomodulation therapy (PBMT)
DevicePatients will receive PBM on the sole of their feet and palms of their hands
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Experimental groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline2
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.
Time frame
Session 3 of PBMT3
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.
Time frame
Session 6 of PBMT4
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.
Time frame
Final PBM session (session 9)Secondary outcomes
1
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)
Time frame
Baseline2
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)
Time frame
Session 3 of PBMT3
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)
Time frame
Session 6 of PBMT4
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)
Time frame
Final PBM session (Session 9)Other outcomes
1
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).
Time frame
Baseline2
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).
Time frame
Final PBM session (session 9)3
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).
Time frame
2 weeks post-PBMT4
Appearance and date of local and regional recurrence
The possible appearance and date of local and/or regional recurrence will be collected.
Time frame
1 year follow-up post-PBMTSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jessa Hospital
Lead sponsor
Hasselt University
Collaborator
Source ClinicalTrials.gov