The effect of a helmet type, home-use low-level light therapy device for chemotherapy-induced alopecia: study protocol for a randomized controlled trial

Autor: Cong-Xian Wu, Cheng-Hsin Li, Yi-Hsien Shiao, Huan-Yu Cheng, Tsung-Han Wu, Chun-Hui Lee, Zi-Yu Chang, Yuan-Chieh Yeh
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: Trials, Vol 24, Iss 1, Pp 1-10 (2023)
Druh dokumentu: article
ISSN: 1745-6215
DOI: 10.1186/s13063-023-07823-x
Popis: Abstract Background Alopecia is one of the most common adverse effects of chemotherapy. It reduces the patient’s self-esteem and quality of life and the effect of therapy. Scalp cooling is the only verified current method for prevention but success is not guaranteed, particularly after receiving anthracycline-based combinations. Low-level light therapy has been clinically proven to inhibit the progress of androgenic alopecia. A previous study using human subjects shows limited benefits for low-level light therapy for patients who suffer chemotherapy-induced alopecia but an increase in the number of probes and the optimization of light sources may improve the efficacy. This study determines the efficacy of low-level light therapy for the prevention of chemotherapy-induced hair loss for patients with breast cancer using a randomized controlled trial. Methods One hundred six eligible breast cancer patients were randomly distributed into a low-level light therapy group and a control group, after receiving chemotherapy. Subjects in the low-level light therapy group received 12 courses of intervention within 4 weeks. Subjects in the control group received no intervention but were closely monitored. The primary outcome is measured as the difference in the hair count in a target area between the baseline and at the end of week 4, as measured using a phototrichogram (Sentra scalp analyzer). The secondary outcomes include the change in hair count at the end of week 1, week 2, and week 3 and hair width at the end of week 1, week 2, week 3, and week 4, as measured using a phototrichogram, and the change in distress, the quality of life, and self-esteem due to chemotherapy-induced alopecia, at the end of week 4, as measured using a questionnaire. Discussion This study improves cancer patients’ quality of life and provides clinical evidence. Trial registration Registered at ClinicalTrials.gov— NCT05397457 on 1 June 2022.
Databáze: Directory of Open Access Journals
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