Clinical trial NCT04979078: Photobiomodulation Therapy in the Management of Hand-foot Syndrome and Hand-foot Skin Reaction
Official title: Evaluating the Effectiveness of Photobiomodulation Therapy in the Management of Hand-foot Syndrome and Hand-foot Skin Reaction: A Single-arm Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Light therapy
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
Collaborators: name: Hasselt University
First posted: 2021-07-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Skin reaction evaluation - CTCAE
timeFrame: Baseline
measure: Skin reaction evaluation - CTCAE
timeFrame: Session 3 of PBMT
measure: Skin reaction evaluation - CTCAE
timeFrame: Session 6 of PBMT
measure: Skin reaction evaluation - CTCAE
timeFrame: Final PBM session (session 9)
measure: Skin reaction evaluation - CTCAE
timeFrame: 2 weeks post-PBMT
measure: Skin reaction evaluation - WHO
timeFrame: Baseline
measure: Skin reaction evaluation - WHO
timeFrame: Session 3 of PBMT
measure: Skin reaction evaluation - WHO
timeFrame: Session 6 of PBMT
measure: Skin reaction evaluation - WHO
timeFrame: Final PBM session (session 9)
measure: Skin reaction evaluation - WHO
timeFrame: 2 weeks post-PBMT
measure: Clinical photograph
timeFrame: Baseline
measure: Clinical photograph
timeFrame: Session 3 of PBMT
measure: Clinical photograph
timeFrame: Session 6 of PBMT
measure: Clinical photograph
timeFrame: Final PBM session (session 9)
measure: Clinical photograph
timeFrame: 2 weeks post-PBMT
Secondary outcomes:
measure: Patient subjective evaluation of skin reactions
timeFrame: Baseline
measure: Patient subjective evaluation of skin reactions
timeFrame: Session 3 of PBMT
measure: Patient subjective evaluation of skin reactions
timeFrame: Session 6 of PBMT
measure: Patient subjective evaluation of skin reactions
timeFrame: Final PBM session (Session 9)
measure: Patient subjective evaluation of skin reactions
timeFrame: 2 weeks post-PBMT
measure: Quality of life - DLQI
timeFrame: Baseline
measure: Quality of life - DLQI
timeFrame: Session 3 of PBMT
measure: Quality of life - DLQI
timeFrame: Session 6 of PBMT
measure: Quality of life - DLQI
timeFrame: Final PBM session (session 9)
measure: Quality of life - DLQI
timeFrame: 2 weeks post-PBMT
measure: Quality of life - Skindex-29
timeFrame: Baseline
measure: Quality of life - Skindex-29
timeFrame: Session 3 of PBMT
measure: Quality of life - Skindex-29
timeFrame: Session 6 of PBMT
measure: Quality of life - Skindex-29
timeFrame: Final PBM session (session 9)
measure: Quality of life - Skindex-29
timeFrame: 2 weeks post-PBMT
measure: Patients' satisfaction with the therapeutic intervention
timeFrame: Final PBM session (session 9)
measure: Patients' satisfaction with the therapeutic intervention
timeFrame: Two weeks post-PBMT
Other outcomes:
measure: General patient-, disease-, and treatment-related information
timeFrame: Baseline
measure: General patient-, disease-, and treatment-related information
timeFrame: Final PBM session (session 9)
measure: General patient-, disease-, and treatment-related information
timeFrame: 2 weeks post-PBMT
measure: Appearance and date of local and regional recurrence
timeFrame: 1 year follow-up post-PBMT
measure: Appearance and date of local and regional recurrence
timeFrame: 2 year follow-up post-PBMT
measure: Appearance and date of local and regional recurrence
timeFrame: 3 year follow-up post-PBMT
measure: Appearance and date of local and regional recurrence
timeFrame: 4 year follow-up post-PBMT
measure: Appearance and date of local and regional recurrence
timeFrame: 5 year follow-up post-PBMT
measure: Appearance and date of secondary tumors
timeFrame: 1 year follow-up post-PBMT
measure: Appearance and date of secondary tumors
timeFrame: 2 year follow-up post-PBMT
measure: Appearance and date of secondary tumors
timeFrame: 3 year follow-up post-PBMT
measure: Appearance and date of secondary tumors
timeFrame: 4 year follow-up post-PBMT
measure: Appearance and date of secondary tumors
timeFrame: 5 year follow-up post-PBMT
measure: Appearance and date of distant metastasis
timeFrame: 1 year follow-up post-PBMT
measure: Appearance and date of distant metastasis
timeFrame: 2 year follow-up post-PBMT
measure: Appearance and date of distant metastasis
timeFrame: 3 year follow-up post-PBMT
measure: Appearance and date of distant metastasis
timeFrame: 4 year follow-up post-PBMT
measure: Appearance and date of distant metastasis
timeFrame: 5 year follow-up post-PBMT
measure: Date of death of any cause
timeFrame: 1 year follow-up post-PBMT
measure: Date of death of any cause
timeFrame: 2 year follow-up post-PBMT
measure: Date of death of any cause
timeFrame: 3 year follow-up post-PBMT
measure: Date of death of any cause
timeFrame: 4 year follow-up post-PBMT
measure: Date of death of any cause
timeFrame: 5 year follow-up post-PBMT
Locations:
city: Hasselt
country: Belgium
facility: Hasselt University
state: Limburg
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis VZW
state: Limburg
Study officials:
affiliation: Head of Medical Oncology Department
name: Jeroen Mebis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: