PBMT for the Management of CIA ( HAIRLASER )
Photobiomodulation Therapy for the Management of Chemotherapy-induced Alopecia: a Randomized, Placebo-controlled Feasibility Trial
1 other identifier
interventional
30
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable breast-cancer
Started Jun 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2019
CompletedFirst Posted
Study publicly available on registry
July 30, 2019
CompletedStudy Start
First participant enrolled
June 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedMarch 23, 2022
March 1, 2022
2 years
July 25, 2019
March 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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'.
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'.
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'.
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'.
Month 3
Secondary Outcomes (9)
EORTC QLQ-C30 Quality of life questionnaire
Baseline
EORTC QLQ-C30 Quality of life questionnaire
Month 1
EORTC QLQ-C30 Quality of life questionnaire
Month 2
EORTC QLQ-C30 Quality of life questionnaire
Month 3
QLQ-BR23 Quality of life questionnaire
Baseline
- +4 more secondary outcomes
Study Arms (2)
Experimental: Treatment group
ACTIVE COMPARATORControl group (no intervention)
NO INTERVENTIONInterventions
All patients will undergo photobiomodulation therapy sessions three times a week for the total duration of 12 weeks starting at their last CT administration.
Eligibility Criteria
You may qualify if:
- 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
- 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).
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hasselt Universitylead
- Jessa Hospitalcollaborator
Study Sites (1)
Jessa Ziekenhuis
Hasselt, 3500, Belgium
Related Publications (1)
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.
PMID: 37060420DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeroen Mebis, prof. dr.
Jessa Hospital
- STUDY CHAIR
Joy Lodewijckx, drs.
Hasselt University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 25, 2019
First Posted
July 30, 2019
Study Start
June 17, 2020
Primary Completion
June 30, 2022
Study Completion
December 31, 2022
Last Updated
March 23, 2022
Record last verified: 2022-03