NCT05397457

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started May 2022

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2026

Completed
Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

May 19, 2022

Last Update Submit

March 18, 2026

Conditions

Breast CancerChemotherapy-induced Alopecia

Outcome Measures

Primary Outcomes (2)

  • Hair counts recorded by Sentra scalp analyzer

    Sentra scalp analyzer is an innovative phototrichogram, combining the technique of trichoscopy, image capture, and image interpretation. This device can be utilized to measure hair counts and hair width. We will record hair counts in the frontal, parietal, and occipital regions.

    Baseline

  • Hair counts recorded by Sentra scalp analyzer

    Sentra scalp analyzer is an innovative phototrichogram, combining the technique of trichoscopy, image capture, and image interpretation. This device can be utilized to measure hair counts and hair width. We will record hair counts in the frontal, parietal, and occipital regions.

    12th course of intervention (four weeks after the first course of intervention)

Secondary Outcomes (16)

  • Chemotherapy-Induced Alopecia Distress Scale

    Baseline

  • Chemotherapy-Induced Alopecia Distress Scale

    12th course of intervention (four weeks after the first course of intervention)

  • Rosenberg Self-esteem Scale

    Baseline

  • Rosenberg Self-esteem Scale

    12th course of intervention (four weeks after the first course of intervention)

  • European Quality of Life 5 Dimensions 5 Level Version

    Baseline

  • +11 more secondary outcomes

Study Arms (2)

Treatment group

EXPERIMENTAL
Device: low-level light therapy

Control group

NO INTERVENTION

Interventions

low-level light therapyDEVICE

Device: Hair Boom 69 All participants within the experimental group will undergo low-level light therapy sessions 3 times a week for the total duration of 4 weeks starting at their last CT administration. If the participants can not cooperate to receive the therapy 3 times a week due to personal reasons, we will recommend that they undergo 2 courses of the therapy per week at least and finish the 12 courses of the intervention in 6 weeks.

Treatment group

Eligibility Criteria

Age20 Years - 75 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Keelung Chang Gung Memorial Hospital

Keelung, 20401, Taiwan

Location

Related Publications (1)

  • Wu CX, Li CH, Shiao YH, Cheng HY, Wu TH, Lee CH, Chang ZY, Yeh YC. The effect of a helmet type, home-use low-level light therapy device for chemotherapy-induced alopecia: study protocol for a randomized controlled trial. Trials. 2023 Dec 5;24(1):789. doi: 10.1186/s13063-023-07823-x.

    PMID: 38053197DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director, Assistant professor

Study Record Dates

First Submitted

May 19, 2022

First Posted

May 31, 2022

Study Start

May 1, 2022

Primary Completion

May 1, 2025

Study Completion

March 17, 2026

Last Updated

March 20, 2026

Record last verified: 2026-03

Locations

TW(1)