%0 Clinical Trial Protocol
%T The effect of a helmet type, home-use low-level light therapy device for chemotherapy-induced alopecia: study protocol for a randomized controlled trial.
%A Wu CX
%A Li CH
%A Shiao YH
%A Cheng HY
%A Wu TH
%A Lee CH
%A Chang ZY
%A Yeh YC
%J Trials
%V 24
%N 1
%D 2023 Dec 5
%M 38053197
%F 2.728
%R 10.1186/s13063-023-07823-x
%X <B>BACKGROUND: </B>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.<BR><B>METHODS: </B>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.<BR><B>CONCLUSIONS: </B>This study improves cancer patients' quality of life and provides clinical evidence.<BR><B>BACKGROUND: </B>Registered at ClinicalTrials.gov- NCT05397457 on 1 June 2022.