PBMT for the Management of CIA ( HAIRLASER )

Not Applicable

• Conditions: Breast Cancer; Chemotherapy-induced Alopecia; Alopecia
• Interventions: Device: Photobiomodulation therapy

• Registration Number: NCT04036994
• Lead Sponsor: Hasselt University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-25
• Study First Submitted QC: 2019-07-29
• Study First Posted: 2019-07-30
• Study Start: 2020-06-17
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-23
• Primary Completion: 2022-06-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: Treatment group	Photobiomodulation therapy	-

Primary Outcome Measures

Name	Time	Method
visual analogue scale (VAS)	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'.

Secondary Outcome Measures

Name	Time	Method
EORTC QLQ-C30 Quality of life questionnaire	Month 3	A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module
QLQ-BR23 Quality of life questionnaire	Month 3	A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module
Patient global satisfaction numerical rating scale	Month 3	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)

Trial Locations

Locations (1)

Jessa Ziekenhuis; 🇧🇪 Hasselt, Belgium