Clinical trial NCT05397457: Effect of Helmet Type, Home-use Low-level Light Therapy Device for Chemotherapy-induced Alopecia
Official title: Effect of Helmet Type, Home-use Photobiomodulation Therapy Device for Chemotherapy-induced Alopecia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Chemotherapy-induced Alopecia
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 106
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Hair counts recorded by Sentra scalp analyzer
timeFrame: Baseline
measure: Hair counts recorded by Sentra scalp analyzer
timeFrame: 12th course of intervention (four weeks after the first course of intervention)
Secondary outcomes:
measure: Chemotherapy-Induced Alopecia Distress Scale
timeFrame: Baseline
measure: Chemotherapy-Induced Alopecia Distress Scale
timeFrame: 12th course of intervention (four weeks after the first course of intervention)
measure: Rosenberg Self-esteem Scale
timeFrame: Baseline
measure: Rosenberg Self-esteem Scale
timeFrame: 12th course of intervention (four weeks after the first course of intervention)
measure: European Quality of Life 5 Dimensions 5 Level Version
timeFrame: Baseline
measure: European Quality of Life 5 Dimensions 5 Level Version
timeFrame: 12th course of intervention (four weeks after the first course of intervention)
measure: European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire
timeFrame: Baseline
measure: European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire
timeFrame: 12th course of intervention (four weeks after the first course of intervention)
measure: Hair width recorded by Sentra scalp analyzer
timeFrame: Baseline
measure: Hair counts recorded by Sentra scalp analyzer
timeFrame: 3rd course of intervention (one week after the first course of intervention)
measure: Hair width recorded by Sentra scalp analyzer
timeFrame: 3rd course of intervention (one week after the first course of intervention)
measure: Hair counts recorded by Sentra scalp analyzer
timeFrame: 6th course of intervention (two weeks after the first course of intervention)
measure: Hair width recorded by Sentra scalp analyzer
timeFrame: 6th course of intervention (two weeks after the first course of intervention)
measure: Hair counts recorded by Sentra scalp analyzer
timeFrame: 9th course of intervention (three weeks after the first course of intervention)
measure: Hair width recorded by Sentra scalp analyzer
timeFrame: 9th course of intervention (three weeks after the first course of intervention)
measure: Hair width recorded by sentra scalp analyzer
timeFrame: 12th course of intervention (four weeks after the first course of intervention)
Other outcomes:
Locations:
city: Keelung
country: Taiwan
facility: Keelung Chang Gung Memorial Hospital
Study officials:
References: