Effect of Helmet Type, Home-use Low-level Light Therapy Device for Chemotherapy-induced Alopecia

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    88
  • sponsor
    YUAN-CHIEH YEH
Updated on 28 July 2022
paclitaxel
docetaxel
taxane

Summary

As far as breast cancer is concerned, chemotherapy (CT) is an important treatment. However, there are many adverse effects impairing the patients' quality of life (QOL), in which chemotherapy-induced alopecia (CIA) affects up to 65% of the patients. This condition is reversible. Nevertheless, it takes several months after CT for visible hair regrowth. Different characteristics of the new hair are common; for example, 65 percent of the patients have experienced a graying, curling, or straightening effect. Besides, the emotional trauma due to alopecia can not be neglected.

Currently, scalp cooling is the only available and verified management for prevention. Unfortunately, the success rate of scalp cooling is variable, especially among the patients receiving anthracycline-based combinations.

Low-level light therapy (LLLT) has been proven as a therapeutic technique for adrenergic alopecia. Recently, investigators have checked the validity of LLLT for the CIA. Although the preliminary outcome showed failure at accelerating hair recovery, technical progress of LLLT may improve the end result. Specifically, LLLT is a technique that utilizes laser diodes (LD) or light-emitting diodes (LED) to promote tissue repair. The light source from LD has a narrower bandwidth than LED, which can prevent heat-related tissue damage. There were 21 LDs and 30 LEDs in the previous device; in contrast, there are 69 LDs in ours. As a result, we have confidence in the efficacy.

The project aims to explore the effect of low-level light therapy in chemotherapy-induced alopecia. We expect the therapy will lead to an improvement in the patients' hair amount, hair width, and quality of life after chemotherapy.

Details
Condition Breast Cancer, Chemotherapy-induced Alopecia
Treatment Low-level Light Therapy
Clinical Study IdentifierNCT05397457
SponsorYUAN-CHIEH YEH
Last Modified on28 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age: 20 to 75 years
Informed Consent as documented by signature
Able to read and converse in chinese
Female
Diagnosis of breast cancer
They completed chemotherapy no more than 2 weeks
Treatment with neoadjuvant (preoperative) or adjuvant (postoperative) chemotherapy: anthracycline and taxane containing (paclitaxel or docetaxel) chemotherapy regimen
life expectancy was at least 6 months
Diagnosed with CIA grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE)

Exclusion Criteria

scalp tumor or melanoma
having any serious mental illness or history, or taking psychotropic drugs
a medical history of dermatosis
severe liver and kidney damage
Pregnancy
Take any of the following medications for 6 months prior to initiation of the study: topical minoxidil, and spironolactone, and topical calcitriol
Receiving scalp cooling during chemotherapy
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