Breast CancerNCT05397457
Effect of Helmet Type, Home-use Low-level Light Therapy Device for Chemotherapy-induced Alopecia
A study testing low-level light therapy in people with Breast Cancer and Chemotherapy-induced Alopecia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Chemotherapy-induced Alopecia
- What is being tested?
- low-level light therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2022to 17 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Helmet Type, Home-use Photobiomodulation Therapy Device for Chemotherapy-induced Alopecia
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.
Read more
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.
- Conditions
- Breast Cancer, Chemotherapy-induced Alopecia
- Being tested
- low-level light therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Not described Receives: Device: low-level light therapy |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12th course of intervention (four weeks after the first course of intervention)
Secondary outcomes (16)
Chemotherapy-Induced Alopecia Distress Scale
A validated questionnaire was developed by the Korean Organization for Researching distress due to chemotherapy-induced alopecia.
The minimum and maximum scores on the chemotherapy-induced alopecia distress scale are 17 and 68, respectively, including 17 items in 4 factors (Physical, emotional, activity, and relationship). The higher value suggests higher chemotherapy-induced distress that the participants encountered.
Measured: Baseline
Chemotherapy-Induced Alopecia Distress Scale
A validated questionnaire was developed by the Korean Organization for Researching distress due to chemotherapy-induced alopecia.
The minimum and maximum scores on the chemotherapy-induced alopecia distress scale are 17 and 68, respectively, including 17 items in 4 factors (Physical, emotional, activity, and relationship). The higher value suggests higher chemotherapy-induced distress that the participants encountered.
Measured: 12th course of intervention (four weeks after the first course of intervention)
Rosenberg Self-esteem Scale
Self-esteem will be measured by Rosenberg's Self-Esteem scale with 10 items. Each item is scored on a 4-point Likert self-report scale, ranging from 0 to 3. A total score is obtained by summing all item scores. The minimum and maximum scores on the scale are 0 and 30. Scoring less than 15 may indicate problematic low self-esteem.
Measured: Baseline
Rosenberg Self-esteem Scale
Self-esteem will be measured by Rosenberg's Self-Esteem scale with 10 items. Each item is scored on a 4-point Likert self-report scale, ranging from 0 to 3. A total score is obtained by summing all item scores. The minimum and maximum scores on the scale are 0 and 30. Scoring less than 15 may indicate problematic low self-esteem.
Measured: 12th course of intervention (four weeks after the first course of intervention)
European Quality of Life 5 Dimensions 5 Level Version
The European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems, indicating his/her health state by ticking the box against the most appropriate statement in each of the 5 dimensions. This decision results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined into a 5-digit number describing the respondent's health state and divided into 5 levels of perceived problems:
Level 1: no problem Level 2: slight problems Level 3: moderate problems Level 4: severe problems Level 5: extreme problems
Measured: Baseline
European Quality of Life 5 Dimensions 5 Level Version
The European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems, indicating his/her health state by ticking the box against the most appropriate statement in each of the 5 dimensions. This decision results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined into a 5-digit number describing the respondent's health state and divided into 5 levels of perceived problems:
Level 1: no problem Level 2: slight problems Level 3: moderate problems Level 4: severe problems Level 5: extreme problems
Measured: 12th course of intervention (four weeks after the first course of intervention)
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire
The European Organization for the Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) is an integrated system for assessing the health-related quality of life (QoL) of cancer patients participating in international clinical trials.
The 30-item questionnaire measuring QLQ (QLQ-C30) is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items.
Each of the multi-item scales includes a different set of items - no item occurs in more than one scale.
All of the scales and single-item measures range in score from 0 to 100. The high scale score represents a high response level.
Thus a high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems
Measured: Baseline
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire
The European Organization for the Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) is an integrated system for assessing the health-related quality of life (QoL) of cancer patients participating in international clinical trials.
The 30-item questionnaire measuring QLQ (QLQ-C30) is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items.
Each of the multi-item scales includes a different set of items - no item occurs in more than one scale.
All of the scales and single-item measures range in score from 0 to 100. The high scale score represents a high response level.
Thus a high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems
Measured: 12th course of intervention (four weeks after the first course of intervention)
Hair width 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 width in the frontal, parietal, and occipital regions.
Measured: 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.
Measured: 3rd course of intervention (one week after the first course of intervention)
Hair width 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 width in the frontal, parietal, and occipital regions.
Measured: 3rd course of intervention (one week after the first course of intervention)
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.
Measured: 6th course of intervention (two weeks after the first course of intervention)
Hair width 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 width in the frontal, parietal, and occipital regions.
Measured: 6th course of intervention (two weeks after the first course of intervention)
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.
Measured: 9th course of intervention (three weeks after the first course of intervention)
Hair width 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 width in the frontal, parietal, and occipital regions.
Measured: 9th course of intervention (three weeks after the first course of intervention)
Hair width 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 width in the frontal, parietal, and occipital regions.
Measured: 12th course of intervention (four weeks after the first course of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start1 May 2022
- Primary completion1 May 2025
- Study completion17 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YUAN-CHIEH YEH, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397457
- Sponsor's protocol ID
- 202200395A3
- Status last verified
- Mar 2026
- First submitted
- 19 May 2022
- Last updated
- 20 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38053197
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Helmet Type, Home-use Photobiomodulation Therapy Device for Chemotherapy-induced Alopecia
- ClinicalTrials.gov ID
- NCT05397457
- Acronym / sponsor ID
- 202200395A3
- Conditions
- Breast Cancer, Chemotherapy-induced Alopecia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 17 Mar 2026 (actual)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: low-level light therapy |
| Control group | No intervention | – |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age: 20 to 75 years
- Informed Consent as documented by signature.
- Able to read and converse in chinese
- Female
- Diagnosis of breast cancer
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low-level light therapyDevice: 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. | Device | Treatment group |
Primary outcome
Hair counts recorded by Sentra scalp analyzer
Time frame: Baseline
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.
Hair counts recorded by Sentra scalp analyzer
Time frame: 12th course of intervention (four weeks after the first course of intervention)
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.
16 secondary outcomes
Chemotherapy-Induced Alopecia Distress Scale
Time frame: Baseline
Chemotherapy-Induced Alopecia Distress Scale
Time frame: 12th course of intervention (four weeks after the first course of intervention)
Rosenberg Self-esteem Scale
Time frame: Baseline
Rosenberg Self-esteem Scale
Time frame: 12th course of intervention (four weeks after the first course of intervention)
European Quality of Life 5 Dimensions 5 Level Version
Time frame: Baseline
European Quality of Life 5 Dimensions 5 Level Version
Time frame: 12th course of intervention (four weeks after the first course of intervention)
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire
Time frame: Baseline
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire
Time frame: 12th course of intervention (four weeks after the first course of intervention)
Hair width recorded by Sentra scalp analyzer
Time frame: Baseline
Hair counts recorded by Sentra scalp analyzer
Time frame: 3rd course of intervention (one week after the first course of intervention)
Hair width recorded by Sentra scalp analyzer
Time frame: 3rd course of intervention (one week after the first course of intervention)
Hair counts recorded by Sentra scalp analyzer
Time frame: 6th course of intervention (two weeks after the first course of intervention)
Hair width recorded by Sentra scalp analyzer
Time frame: 6th course of intervention (two weeks after the first course of intervention)
Hair counts recorded by Sentra scalp analyzer
Time frame: 9th course of intervention (three weeks after the first course of intervention)
Hair width recorded by Sentra scalp analyzer
Time frame: 9th course of intervention (three weeks after the first course of intervention)
Hair width recorded by sentra scalp analyzer
Time frame: 12th course of intervention (four weeks after the first course of intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Derived from this study: PubMed 38053197Wu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low-level light therapy in people with Breast Cancer and Chemotherapy-induced Alopecia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hair counts recorded by Sentra scalp analyzer (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05397457, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.