Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2020-06-17
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Experimental: Treatment group
Photobiomodulation 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.
Control group (no intervention)
No interventions assigned to this group
Interventions
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Photobiomodulation 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
Exclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Jessa Hospital
OTHER
Hasselt University
OTHER
Responsible Party
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Prof. dr. Jeroen Mebis
Principal Investigator
Principal Investigators
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Jeroen Mebis, prof. dr.
Role: PRINCIPAL_INVESTIGATOR
Jessa Hospital
Joy Lodewijckx, drs.
Role: STUDY_CHAIR
Hasselt University
Locations
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Jessa Ziekenhuis
Hasselt, , Belgium
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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19.58/ONCO19.08
Identifier Type: -
Identifier Source: org_study_id
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