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

Chang Gung Medical Foundation

Status

Enrolling

Conditions

Breast Cancer

Chemotherapy-induced Alopecia

Treatments

Device: low-level light therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05397457

202200395A3

Details and patient eligibility

About

As far as breast cancer is concerned, chemotherapy (CT) is an important treatment. However, there are many adverse effects impairing the patient's 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 is coherent while LED is an incoherent light source. Therefore, LDs can deliver energy to tissues more efficiently than LEDs. To comprehensively evaluate the beneficial effect of LLLT in treating CIA, we conduct a clinical trial with a more advanced device equipped with 69 LDs.

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 patient's hair count, hair width, and quality of life after chemotherapy.

Enrollment

106 estimated patients

Sex

Female

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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