The Effect of a Helmet-Type, Home-Use Low-Level Light Therapy Device for Chemotherapy-Induced Alopecia: Study Protocol for a Randomized Controlled Trial

    December 2023 in “ Trials
    Chun-Yu Wu, C. Li, Yi-Hsien Shiao, Haiying Cheng, Tsung‐Han Wu, Chun‐Hui Lee, Zi‐Yu Chang, Yuan-Chieh Yeh
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    TLDR The trial is testing if a helmet that uses light can prevent hair loss during chemotherapy.
    This document presents a study protocol for a randomized controlled trial investigating the efficacy of a helmet-type, home-use low-level light therapy (LLLT) device in preventing hair loss in 106 breast cancer patients undergoing chemotherapy. The LLLT device, developed by Won Technology, emits 650 nm light and is used three times per week for 4 weeks. The primary outcome is the difference in hair count between the start and end of the 4-week study period. Secondary outcomes include changes in hair count and width each week, and changes in distress, quality of life, and self-esteem due to hair loss at the end of the 4 weeks. The study acknowledges limitations such as the inability to blind patients in the control group and the short follow-up duration. The trial was registered in June 2022 and is expected to be completed by August 2025.
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