NCT04979078

Photobiomodulation Therapy in the Management of Hand-foot Syndrome and Hand-foot Skin Reaction

Evaluating the Effectiveness of Photobiomodulation Therapy in the Management of Hand-foot Syndrome and Hand-foot Skin Reaction: A Single-arm Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Jessa Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hand-foot Syndrome
• Hand-foot Skin Reaction

Interventions

Type	Name	Description
DEVICE	Photobiomodulation therapy (PBMT)	Patients will receive PBM on the sole of their feet and palms of their hands

Timeline

• Start date: 2022-01-12
• Primary completion: 2024-08-01
• Completion: 2029-08-01
• First posted: 2021-07-27
• Last updated: 2023-06-18

Locations

2 sites across 1 country: Belgium