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

Study acronym: DermLight
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 18, 2023 (before its estimated August 2024 completion). Its status may not reflect the trial's current state.

Record History

  1. Notable Primary completion date: Mar 2023 to Aug 2024
    • Study completion date: Mar 2028 to Aug 2029
    v5
  2. Minor Re-verified, no change to tracked fieldsv4
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 2021 to Jan 12, 2022
    • Site details revised at 2 of 2 sites
    v3
  4. Notable Start date: Sep 2021 to Dec 2021v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04979078
Lead Sponsor Jessa Hospital
Collaborators: Hasselt University
Conditions
(from sponsor)
Hand-foot Syndrome, Hand-foot Skin Reaction
Related terms Hand-Foot Syndrome, Neoplasms
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov