Breast CancerNCT04036994
PBMT for the Management of CIA ( HAIRLASER )
A study testing Photobiomodulation therapy in people with Breast Cancer and Chemotherapy-induced Alopecia, run by Hasselt University at 1 site in Belgium.
Trial summary
Chemotherapy (CT) remains an important treatment modality for breast cancer patients. Unfortunately, this systemic treatment comes with many quality of life impairing complications. Chemotherapy-induced alopecia (CIA) occurs in about 65% of the patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Chemotherapy-induced Alopecia, Alopecia
- What is being tested?
- Photobiomodulation therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Jun 2020to 31 Dec 2022
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent as documented by signature.
- Age 18 years or above
- Female
- Use of a wig for at least 2 hours a day
- Able to read and converse in Dutch
- Skin type I to IV on the Fitzpatrick Skin Type Scale
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- Diagnosis of non-invasive (stage 0) or invasive (stage 1, 2 and 3A) breast adenocarcinoma.
- Treatment with neoadjuvant (preoperative) or adjuvant (postoperative) chemotherapy: anthracycline and taxane containing (paclitaxel or docetaxel) chemotherapy regimen.
- Diagnosed with CIA grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE)
- Have no documented or observable psychiatric or neurological disorders that might interfere with study participation (e.g., dementia or psychosis).
Who cannot join
- Metastatic disease
- Severe or unstable cardio- respiratory or musculoskeletal disease
- Pregnancy
- Presence of cognitive impairment that might impact study outcomes
- Previously (before start of chemotherapy) diagnosed with a hair loss condition
- Receiving scalp cooling during chemotherapy
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- Active infection on the scalp
- Chronic dermatologic condition (e.g. eczema, psoriasis, infection)
- Take any of the following medications for 6 months prior to initiation of the study: minoxidil, finasteride (or any other 5α-reductase inhibitor medications), medications with anti-androgenic properties (e.g. cyproterone, spironolactone, ketoconazole, flutamide and bicalutamide)n medications that can potentially cause hypertrichosis (ciclosporin, diazoxide, phenytoin and psoralens), and oral glucocorticoids
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Jessa Ziekenhuis
Hasselt, 3500
Jeroen Mebis, prof.dr., jeroen.mebis@jessazh.be
Joy Lodewijckx, drs., joy.lodewijckx@uhasselt.be
About this study
Official title: Photobiomodulation Therapy for the Management of Chemotherapy-induced Alopecia: a Randomized, Placebo-controlled Feasibility Trial
Chemotherapy (CT) remains an important treatment modality for breast cancer patients. Unfortunately, this systemic treatment comes with many quality of life impairing complications. Chemotherapy-induced alopecia (CIA) occurs in about 65% of the patients. Hair loss due to CT is reversible, but hair regrowth requires several months to a year after CT. Currently, the only available preventive measure is based on scalp cooling. Nevertheless, this treatment has a highly variable success rate and it brings along several side effects. Photobiomodulation therapy (PBMT) is a new, preventive and therapeutic technique in the supportive care of cancer patients. It uses visible and (near)- infrared light produced by laser diodes or light-emitting diodes (LED) at a low power to stimulate tissue repair and reduce inflammation and pain. The investigator's research team demonstrated already that PBMT can prevent oral mucositis and acute radiodermatitis. The aim of this project is to explore the use of PBMT in the management of CIA. Results of this project will lead to an improvement of the patients' quality of life after CT.
- Conditions
- Breast Cancer, Chemotherapy-induced Alopecia, Alopecia
- Being tested
- Photobiomodulation therapy
- Keywords
- photomodulation therapy, supportive cancer care, epirubicin cyclophosphamide
- Medical subject headings
- Breast Neoplasms, Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation therapyDevice
Also called Low level laser therapy
All patients will undergo photobiomodulation therapy sessions three times a week for the total duration of 12 weeks starting at their last CT administration.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Treatment group | Active comparator | Not described Receives: Device: Photobiomodulation therapy |
| Control group (no intervention) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale (VAS)
A mechanical visual analogue scale (VAS) will be used to evaluate the patients' hair regrowth based on photographs taken at the four time points. The patients will be asked to indicate their subjective experience of hair regrowth. This score is associated with a certain score, in which 0 = 'total baldness' and 10 = 'full scalp coverage'.
Measured: Baseline
visual analogue scale (VAS)
A mechanical visual analogue scale (VAS) will be used to evaluate the patients' hair regrowth based on photographs taken at the four time points. The patients will be asked to indicate their subjective experience of hair regrowth. This score is associated with a certain score, in which 0 = 'total baldness' and 10 = 'full scalp coverage'.
Measured: Month 1
visual analogue scale (VAS)
A mechanical visual analogue scale (VAS) will be used to evaluate the patients' hair regrowth based on photographs taken at the four time points. The patients will be asked to indicate their subjective experience of hair regrowth. This score is associated with a certain score, in which 0 = 'total baldness' and 10 = 'full scalp coverage'.
Measured: Month 2
visual analogue scale (VAS)
A mechanical visual analogue scale (VAS) will be used to evaluate the patients' hair regrowth based on photographs taken at the four time points. The patients will be asked to indicate their subjective experience of hair regrowth. This score is associated with a certain score, in which 0 = 'total baldness' and 10 = 'full scalp coverage'.
Measured: Month 3
Secondary outcomes (9)
EORTC QLQ-C30 Quality of life questionnaire
A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module
Measured: Baseline
EORTC QLQ-C30 Quality of life questionnaire
A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module
Measured: Month 1
EORTC QLQ-C30 Quality of life questionnaire
A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module
Measured: Month 2
EORTC QLQ-C30 Quality of life questionnaire
A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module
Measured: Month 3
QLQ-BR23 Quality of life questionnaire
A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module
Measured: Baseline
QLQ-BR23 Quality of life questionnaire
A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module
Measured: Month 1
QLQ-BR23 Quality of life questionnaire
A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module
Measured: Month 2
QLQ-BR23 Quality of life questionnaire
A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module
Measured: Month 3
Patient global satisfaction numerical rating scale
The patients' global satisfaction with the PBMT/sham therapy will be evaluated using a numerical rating scale (NRS) from 0 (minimum score) to 10 (maximum score)
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start17 Jun 2020
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Dec 2022 (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 Breast CancerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital
- Responsible party
- Principal investigator, Prof. dr. Jeroen Mebis, Hasselt University
- Investigators
- Jeroen Mebis, prof. dr., Principal investigator, Jessa HospitalJoy Lodewijckx, drs., Study chair, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036994
- Sponsor's protocol ID
- 19.58/ONCO19.08
- Status last verified
- Mar 2022
- First submitted
- 25 Jul 2019
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lodewijckx J, Robijns J, Claes M, Pierson M, Lenaerts M, Mebis J. The use of photobiomodulation therapy for the management of chemotherapy-induced alopecia: a randomized, controlled trial (HAIRLASER trial). Support Care Cancer. 2023 Apr 15;31(5):269. doi: 10.1007/s00520-023-07743-1.
PubMed 37060420
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photobiomodulation Therapy for the Management of Chemotherapy-induced Alopecia: a Randomized, Placebo-controlled Feasibility Trial
- ClinicalTrials.gov ID
- NCT04036994
- Acronym / sponsor ID
- 19.58/ONCO19.08
- Conditions
- Breast Cancer, Chemotherapy-induced Alopecia, Alopecia
- Keywords
- photomodulation therapy, supportive cancer care, epirubicin cyclophosphamide
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Jessa Hospital
- Study start
- 17 Jun 2020 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 30 Jul 2019 (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.
Chemotherapy (CT) remains an important treatment modality for breast cancer patients. Unfortunately, this systemic treatment comes with many quality of life impairing complications. Chemotherapy-induced alopecia (CIA) occurs in about 65% of the patients. Hair loss due to CT is reversible, but hair regrowth requires several months to a year after CT. Currently, the only available preventive measure is based on scalp cooling. Nevertheless, this treatment has a highly variable success rate and it brings along several side effects. Photobiomodulation therapy (PBMT) is a new, preventive and therapeutic technique in the supportive care of cancer patients. It uses visible and (near)- infrared light produced by laser diodes or light-emitting diodes (LED) at a low power to stimulate tissue repair and reduce inflammation and pain. The investigator's research team demonstrated already that PBMT can prevent oral mucositis and acute radiodermatitis. The aim of this project is to explore the use of PBMT in the management of CIA. Results of this project will lead to an improvement of the patients' quality of life after CT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Treatment group | Active comparator | Device: Photobiomodulation therapy |
| Control group (no intervention) | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Informed Consent as documented by signature.
- Age 18 years or above
- Female
- Use of a wig for at least 2 hours a day
- Able to read and converse in Dutch
Key exclusion criteria (9 listed)
- Metastatic disease
- Severe or unstable cardio- respiratory or musculoskeletal disease
- Pregnancy
- Presence of cognitive impairment that might impact study outcomes
- Previously (before start of chemotherapy) diagnosed with a hair loss condition
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 |
|---|---|---|
| Photobiomodulation therapyAlso: Low level laser therapyAll patients will undergo photobiomodulation therapy sessions three times a week for the total duration of 12 weeks starting at their last CT administration. | Device | Experimental: Treatment group |
Primary outcome
visual analogue scale (VAS)
Time frame: Baseline
A mechanical visual analogue scale (VAS) will be used to evaluate the patients' hair regrowth based on photographs taken at the four time points. The patients will be asked to indicate their subjective experience of hair regrowth. This score is associated with a certain score, in which 0 = 'total baldness' and 10 = 'full scalp coverage'.
visual analogue scale (VAS)
Time frame: Month 1
A mechanical visual analogue scale (VAS) will be used to evaluate the patients' hair regrowth based on photographs taken at the four time points. The patients will be asked to indicate their subjective experience of hair regrowth. This score is associated with a certain score, in which 0 = 'total baldness' and 10 = 'full scalp coverage'.
visual analogue scale (VAS)
Time frame: Month 2
A mechanical visual analogue scale (VAS) will be used to evaluate the patients' hair regrowth based on photographs taken at the four time points. The patients will be asked to indicate their subjective experience of hair regrowth. This score is associated with a certain score, in which 0 = 'total baldness' and 10 = 'full scalp coverage'.
visual analogue scale (VAS)
Time frame: Month 3
A mechanical visual analogue scale (VAS) will be used to evaluate the patients' hair regrowth based on photographs taken at the four time points. The patients will be asked to indicate their subjective experience of hair regrowth. This score is associated with a certain score, in which 0 = 'total baldness' and 10 = 'full scalp coverage'.
9 secondary outcomes
EORTC QLQ-C30 Quality of life questionnaire
Time frame: Baseline
EORTC QLQ-C30 Quality of life questionnaire
Time frame: Month 1
EORTC QLQ-C30 Quality of life questionnaire
Time frame: Month 2
EORTC QLQ-C30 Quality of life questionnaire
Time frame: Month 3
QLQ-BR23 Quality of life questionnaire
Time frame: Baseline
QLQ-BR23 Quality of life questionnaire
Time frame: Month 1
QLQ-BR23 Quality of life questionnaire
Time frame: Month 2
QLQ-BR23 Quality of life questionnaire
Time frame: Month 3
Patient global satisfaction numerical rating scale
Time frame: Month 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Derived from this study: PubMed 37060420Lodewijckx J, Robijns J, Claes M, Pierson M, Lenaerts M, Mebis J. The use of photobiomodulation therapy for the management of chemotherapy-induced alopecia: a randomized, controlled trial (HAIRLASER trial). Support Care Cancer. 2023 Apr 15;31(5):269. doi: 10.1007/s00520-023-07743-1.
- Individual participant dataSharing planned: Undecided
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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.
Jeroen Mebis, prof. dr. principal investigator
Jessa Hospital
Joy Lodewijckx, drs. study chair
Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation therapy in people with Breast Cancer and Chemotherapy-induced Alopecia, run by Hasselt University 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 10 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 23 Mar 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeroen Mebis, prof. dr. (+ 32 11 33 79 79, jeroen.mebis@jessazh.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analogue scale (VAS) (time frame: Baseline). The study lists 4 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 NCT04036994, 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 23 Mar 2022.