PBMT for the Management of CIA ( HAIRLASER )

Hasselt University30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Breast Cancer Chemotherapy-induced Alopecia

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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'.

Time frame: Baseline

visual analogue scale (VAS)

Time frame: Month 1

visual analogue scale (VAS)

Time frame: Month 2

visual analogue scale (VAS)

Time frame: Month 3