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

Condition(s) studied

Investigational drug(s) / intervention(s)

Photobiomodulation therapy (PBMT): Patients will receive PBM on the sole of their feet and palms of their hands

Study 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.

Eligibility

Primary outcome measure(s)

• 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.
• Skin reaction evaluation - CTCAE — Session 3 of PBMT
  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.
• Skin reaction evaluation - CTCAE — Session 6 of PBMT
  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.
• Skin reaction evaluation - CTCAE — Final PBM session (session 9)
  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.
• Skin reaction evaluation - CTCAE — 2 weeks post-PBMT
  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.
• 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
• Skin reaction evaluation - WHO — Session 3 of PBMT
  The severity of the skin reactions will be evaluated by the World Health Association (WHO) grading scale for HFS/HFSR
• Skin reaction evaluation - WHO — Session 6 of PBMT
  The severity of the skin reactions will be evaluated by the World Health Association (WHO) grading scale for HFS/HFSR
• Skin reaction evaluation - WHO — Final PBM session (session 9)
  The severity of the skin reactions will be evaluated by the World Health Association (WHO) grading scale for HFS/HFSR
• Skin reaction evaluation - WHO — 2 weeks post-PBMT
  The severity of the skin reactions will be evaluated by the World Health Association (WHO) grading scale for HFS/HFSR
• Clinical photograph — Baseline
  A clinical photograph of the palm of patients' hands and sole of their feet
• Clinical photograph — Session 3 of PBMT
  A clinical photograph of the palm of patients' hands and sole of their feet
• Clinical photograph — Session 6 of PBMT
  A clinical photograph of the palm of patients' hands and sole of their feet
• Clinical photograph — Final PBM session (session 9)
  A clinical photograph of the palm of patients' hands and sole of their feet
• Clinical photograph — 2 weeks post-PBMT
  A clinical photograph of the palm of patients' hands and sole of their feet

Trial sites (2)

More Jessa Hospital trials in Belgium