Chemotherapy-induced AlopeciaHairLightNCT05177289
Photobiomodulation Therapy in the Prevention and Management of Chemotherapy-Induced Alopecia
A study testing Theradome® LH80 pro and Scalp cooling in people with Chemotherapy-induced Alopecia, run by Jessa Hospital at 1 site in Belgium.
Trial summary
This study aims to investigate the effectiveness of photobiomodulation therapy (PBM) in the prevention and management of chemotherapy-induced alopecia (CIA). Therefore, we hypothesize that PBMT can reduce the severity of CIA in gynecological and breast cancer patients, increasing the patient's QoL. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chemotherapy-induced Alopecia
- What is being tested?
- Theradome® LH80 pro and Scalp cooling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Feb 2022to Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with gynecological cancer (endometrium, cervix, ovarian or vulva) or breast cancer
- Receiving chemotherapy ((Carbo)-Taxol)
- Age ≥ 18 years
- Able to comply to the study protocol
- Able to sign written informed consent
Who cannot join
- Metastatic disease
- Pregnancy
- Active infection of the scalp
- Previous diagnosis of a hair loss condition
- Interruption of chemotherapy for more than two consecutive cycles
- Medication to stimulate hair growth (e.g., Minoxidil)
Show all 10Show fewer
- Severe psychological disorder or dementia.
- Inability to speak and understand Dutch
- Substance abuse patients or patients with medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results as judged by the investigator
- Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Jessa Hospital
Hasselt, Limburg, 3500
Jeroen Mebis, Prof. Dr., +32 11 33 72 21, jeroen.mebis@jessazh.be
Marithé Marithé, MSc, +32 11 33 72 39, marithe.claes@uhasselt.be
About this study
Official title: Evaluating the Feasibility and Efficacy of Photobiomodulation Therapy in the Prevention and Management of Chemotherapy-induced Alopecia: a Randomized Controlled Trial
This study aims to investigate the effectiveness of photobiomodulation therapy (PBM) in the prevention and management of chemotherapy-induced alopecia (CIA). Therefore, we hypothesize that PBMT can reduce the severity of CIA in gynecological and breast cancer patients, increasing the patient's QoL.
Read the detailed description
The global cancer burden keeps rising, and the accompanied side effects remain a significant concern. This project focuses on one of such complications: chemotherapy-induced alopecia (CIA). 65% of cancer patients receiving cytotoxic drugs experience CIA, which negatively impacts their QoL, as hair loss is often associated with impaired body image and increased depression rates. Up to now, prevention of CIA is based on scalp cooling, but this treatment has a highly variable success rate. Photobiomodulation (PBM) therapy is a non-invasive form of phototherapy that utilizes visible and/or near-infrared light to trigger a cascade of intracellular reactions. PBM can be used to improve wound healing, and to reduce pain, inflammation, and edema. Research shows that PBM can stimulate hair growth by increasing the blood flow to the scalp and stimulating the catagen or telogen metabolism of the hair follicle. However, the effect of PBM on CIA has not been adequately investigated.
- Conditions
- Chemotherapy-induced Alopecia
- Being tested
- Theradome® LH80 pro, Scalp cooling
- Keywords
- Photobiomodulation therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theradome® LH80 proDevice
The Theradome LH80 pro is a wearable laser helmet device, which uses red laser light to stop hair loss, thicken existing hair and stimulate the growth of new hair.
Scalp coolingDevice
Scalp cooling is a standard treatment that is applied to prevent hair loss during chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Patients allocated to the treatment group will receive scalp cooling combined with thrice weekly PBM sessions during the CTx course and until one month after the end of CTx. Receives: Device: Theradome® LH80 pro; Device: Scalp cooling |
| Control group | Active comparator | Patients allocated to the control group will receive scalp cooling during their CTx course. Receives: Device: Scalp cooling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair thickness measurement
The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge.
Measured: Baseline
Hair thickness measurement
The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge.
Measured: Halfway into their chemotherapy (An average of 6 weeks)
Hair thickness measurement
The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge.
Measured: At the final chemotherapy session (An average of 12 weeks)
Hair thickness measurement
The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge.
Measured: One month post chemotherapy
CTCAE-score
The patient may grade their hair loss using the CTCAE criteria.
Measured: Baseline
CTCAE-score
The patient may grade their hair loss using the CTCAE criteria.
Measured: Halfway into their chemotherapy (An average of 6 weeks)
CTCAE-score
The patient may grade their hair loss using the CTCAE criteria.
Measured: At the final chemotherapy session (An average of 12 weeks)
CTCAE-score
The patient may grade their hair loss using the CTCAE criteria.
Measured: One month post chemotherapy
Hair loss evaluation
Both the patient and a blinded study nurse will score hair regrowth based on photographs. A score of 0 equals 'total baldness' and 10 'full scalp coverage'.
Measured: Baseline
Hair loss evaluation
Both the patient and a blinded study nurse will score hair regrowth based on photographs. A score of 0 equals 'total baldness' and 10 'full scalp coverage'.
Measured: Halfway into their chemotherapy (An average of 6 weeks)
Hair loss evaluation
Both the patient and a blinded study nurse will score hair regrowth based on photographs. A score of 0 equals 'total baldness' and 10 'full scalp coverage'.
Measured: At the final chemotherapy session (An average of 12 weeks)
Hair loss evaluation
Both the patient and a blinded study nurse will score hair regrowth based on photographs. A score of 0 equals 'total baldness' and 10 'full scalp coverage'.
Measured: One month post chemotherapy
Secondary outcomes (7)
Quality of life score
The European Organization for Research and Treatment for Cancer Quality of Life Questionnaire will be used to evaluate the patients' quality of life.
Measured: Baseline
Quality of life score
The European Organization for Research and Treatment for Cancer Quality of Life Questionnaire will be used to evaluate the patients' quality of life.
Measured: Halfway into their chemotherapy (An average of 6 weeks)
Quality of life score
The European Organization for Research and Treatment for Cancer Quality of Life Questionnaire will be used to evaluate the patients' quality of life.
Measured: At the final chemotherapy session (An average of 12 weeks)
Quality of life score
The European Organization for Research and Treatment for Cancer Quality of Life Questionnaire will be used to evaluate the patients' quality of life.
Measured: One month post chemotherapy
Satisfaction score
The patients will be asked to evaluate their global satisfaction with the therapeutic intervention. The patients will score their satisfaction regarding their treatment on the NRS scale 0 (totally not satisfied) to 10 (very satisfied).
Measured: Halfway into their chemotherapy (An average of 6 weeks)
Satisfaction score
The patients will be asked to evaluate their global satisfaction with the therapeutic intervention. The patients will score their satisfaction regarding their treatment on the NRS scale 0 (totally not satisfied) to 10 (very satisfied).
Measured: At the final chemotherapy session (An average of 12 weeks)
Satisfaction score
The patients will be asked to evaluate their global satisfaction with the therapeutic intervention. The patients will score their satisfaction regarding their treatment on the NRS scale 0 (totally not satisfied) to 10 (very satisfied).
Measured: One month post chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start28 Feb 2022
- Primary completionJan 2025 (estimated)
- Study completionJan 2030 (estimated)
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 Chemotherapy-induced AlopeciaStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeroen Mebis, Prof. Dr., Principal investigator, Jessa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05177289
- Sponsor's protocol ID
- 2021/117
- Acronym
- HairLight
- Status last verified
- Sep 2023
- First submitted
- 9 Dec 2021
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Claes M, Robijns J, Lambrichts L, Van Duffel S, Bulens P, Mebis J. Photobiomodulation therapy in the prevention of chemotherapy-induced alopecia in breast cancer patients: a randomized controlled trial. Lasers Med Sci. 2025 Jul 24;40(1):325. doi: 10.1007/s10103-025-04577-7.
PubMed 40705170
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility and Efficacy of Photobiomodulation Therapy in the Prevention and Management of Chemotherapy-induced Alopecia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05177289
- Acronym / sponsor ID
- HairLight / 2021/117
- Conditions
- Chemotherapy-induced Alopecia
- Keywords
- Photobiomodulation therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 4 Jan 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.
This study aims to investigate the effectiveness of photobiomodulation therapy (PBM) in the prevention and management of chemotherapy-induced alopecia (CIA). Therefore, we hypothesize that PBMT can reduce the severity of CIA in gynecological and breast cancer patients, increasing the patient's QoL.
Detailed description
The global cancer burden keeps rising, and the accompanied side effects remain a significant concern. This project focuses on one of such complications: chemotherapy-induced alopecia (CIA). 65% of cancer patients receiving cytotoxic drugs experience CIA, which negatively impacts their QoL, as hair loss is often associated with impaired body image and increased depression rates. Up to now, prevention of CIA is based on scalp cooling, but this treatment has a highly variable success rate. Photobiomodulation (PBM) therapy is a non-invasive form of phototherapy that utilizes visible and/or near-infrared light to trigger a cascade of intracellular reactions. PBM can be used to improve wound healing, and to reduce pain, inflammation, and edema. Research shows that PBM can stimulate hair growth by increasing the blood flow to the scalp and stimulating the catagen or telogen metabolism of the hair follicle. However, the effect of PBM on CIA has not been adequately investigated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: Theradome® LH80 pro, Device: Scalp coolingPatients allocated to the treatment group will receive scalp cooling combined with thrice weekly PBM sessions during the CTx course and until one month after the end of CTx. |
| Control group | Active comparator | Device: Scalp coolingPatients allocated to the control group will receive scalp cooling during their CTx course. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with gynecological cancer (endometrium, cervix, ovarian or vulva) or breast cancer
- Receiving chemotherapy ((Carbo)-Taxol)
- Age ≥ 18 years
- Able to comply to the study protocol
- Able to sign written informed consent
Key exclusion criteria (10 listed)
- Metastatic disease
- Pregnancy
- Active infection of the scalp
- Previous diagnosis of a hair loss condition
- Interruption of chemotherapy for more than two consecutive cycles
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 |
|---|---|---|
| Theradome® LH80 proThe Theradome LH80 pro is a wearable laser helmet device, which uses red laser light to stop hair loss, thicken existing hair and stimulate the growth of new hair. | Device | Treatment group |
| Scalp coolingScalp cooling is a standard treatment that is applied to prevent hair loss during chemotherapy. | Device | Control group, Treatment group |
Primary outcome
Hair thickness measurement
Time frame: Baseline
The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge.
Hair thickness measurement
Time frame: Halfway into their chemotherapy (An average of 6 weeks)
The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge.
Hair thickness measurement
Time frame: At the final chemotherapy session (An average of 12 weeks)
The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge.
Hair thickness measurement
Time frame: One month post chemotherapy
The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge.
CTCAE-score
Time frame: Baseline
The patient may grade their hair loss using the CTCAE criteria.
CTCAE-score
Time frame: Halfway into their chemotherapy (An average of 6 weeks)
The patient may grade their hair loss using the CTCAE criteria.
CTCAE-score
Time frame: At the final chemotherapy session (An average of 12 weeks)
The patient may grade their hair loss using the CTCAE criteria.
CTCAE-score
Time frame: One month post chemotherapy
The patient may grade their hair loss using the CTCAE criteria.
Hair loss evaluation
Time frame: Baseline
Both the patient and a blinded study nurse will score hair regrowth based on photographs. A score of 0 equals 'total baldness' and 10 'full scalp coverage'.
Hair loss evaluation
Time frame: Halfway into their chemotherapy (An average of 6 weeks)
Both the patient and a blinded study nurse will score hair regrowth based on photographs. A score of 0 equals 'total baldness' and 10 'full scalp coverage'.
Hair loss evaluation
Time frame: At the final chemotherapy session (An average of 12 weeks)
Both the patient and a blinded study nurse will score hair regrowth based on photographs. A score of 0 equals 'total baldness' and 10 'full scalp coverage'.
Hair loss evaluation
Time frame: One month post chemotherapy
Both the patient and a blinded study nurse will score hair regrowth based on photographs. A score of 0 equals 'total baldness' and 10 'full scalp coverage'.
7 secondary outcomes
Quality of life score
Time frame: Baseline
Quality of life score
Time frame: Halfway into their chemotherapy (An average of 6 weeks)
Quality of life score
Time frame: At the final chemotherapy session (An average of 12 weeks)
Quality of life score
Time frame: One month post chemotherapy
Satisfaction score
Time frame: Halfway into their chemotherapy (An average of 6 weeks)
Satisfaction score
Time frame: At the final chemotherapy session (An average of 12 weeks)
Satisfaction score
Time frame: One month post chemotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Derived from this study: PubMed 40705170Claes M, Robijns J, Lambrichts L, Van Duffel S, Bulens P, Mebis J. Photobiomodulation therapy in the prevention of chemotherapy-induced alopecia in breast cancer patients: a randomized controlled trial. Lasers Med Sci. 2025 Jul 24;40(1):325. doi: 10.1007/s10103-025-04577-7.
Related trials for Chemotherapy-induced Alopecia
Not yet recruitingPhase 3
Clinical Study of DA-007 for the Treatment of Chemotherapy Induced Alopecia
Chemotherapy Induced Alopecia, Chemotherapy Side Effects
Recruiting
Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss
Alopecia, Chemotherapy-induced Alopecia
Recruiting
Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color
Alopecia
Not yet recruitingPhase 2
Minoxidil With or Without Low-Level Red-Light Therapy for Improving Chemotherapy-Induced Alopecia in Breast Cancer Patients
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
RecruitingPhase 1/2
Clinical Study of DA-020 for the Treatment of Chemotherapy Induced Alopecia
Chemotherapy Induced Alopecia, Chemotherapy Side Effects
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.
Jeroen Mebis, Prof. Dr. principal investigator
Jessa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theradome® LH80 pro and Scalp cooling in people with Chemotherapy-induced Alopecia, run by Jessa Hospital at 1 site in Belgium.
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 5 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 29 Sep 2023. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeroen Mebis, Prof. Dr. (+32 11 33 72 21, jeroen.mebis@jessazh.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hair thickness measurement (time frame: Baseline). The study lists 12 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 NCT05177289, 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 29 Sep 2023.