Clinical trial NCT04036994: PBMT for the Management of CIA ( HAIRLASER )
Official title: Photobiomodulation Therapy for the Management of Chemotherapy-induced Alopecia: a Randomized, Placebo-controlled Feasibility Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Chemotherapy-induced Alopecia
Alopecia
Keywords: photomodulation therapy
supportive cancer care
epirubicin cyclophosphamide
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Jessa Hospital
First posted: 2019-07-30
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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

Primary outcomes:
measure: visual analogue scale (VAS)
timeFrame: Baseline
measure: visual analogue scale (VAS)
timeFrame: Month 1
measure: visual analogue scale (VAS)
timeFrame: Month 2
measure: visual analogue scale (VAS)
timeFrame: Month 3
Secondary outcomes:
measure: EORTC QLQ-C30 Quality of life questionnaire
timeFrame: Baseline
measure: EORTC QLQ-C30 Quality of life questionnaire
timeFrame: Month 1
measure: EORTC QLQ-C30 Quality of life questionnaire
timeFrame: Month 2
measure: EORTC QLQ-C30 Quality of life questionnaire
timeFrame: Month 3
measure: QLQ-BR23 Quality of life questionnaire
timeFrame: Baseline
measure: QLQ-BR23 Quality of life questionnaire
timeFrame: Month 1
measure: QLQ-BR23 Quality of life questionnaire
timeFrame: Month 2
measure: QLQ-BR23 Quality of life questionnaire
timeFrame: Month 3
measure: Patient global satisfaction numerical rating scale
timeFrame: Month 3
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
Study officials:
affiliation: Jessa Hospital
name: Jeroen Mebis, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasselt University
name: Joy Lodewijckx, drs.
role: STUDY_CHAIR
References: