PBMT for the Management of CIA ( HAIRLASER )

Photobiomodulation Therapy for the Management of Chemotherapy-induced Alopecia: a Randomized, Placebo-controlled Feasibility Trial

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 Overview

• Status: Recruiting
• Conditions: Breast Cancer; Alopecia; Chemotherapy-induced Alopecia
• Intervention / Treatment: Device: Photobiomodulation therapy

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeroen Mebis, prof. dr.; Phone Number: + 32 11 33 79 79; Email: jeroen.mebis@jessazh.be
• Study Contact Backup: Name: Joy Lodewijckx, drs.; Phone Number: +32 11 33 72 30; Email: joy.lodewijckx@uhasselt.be

Study Locations

• Belgium
  • Hasselt, Belgium, 3500
    • Recruiting
    • Jessa Ziekenhuis
    • Contact: Jeroen Mebis, prof.dr.; Email: jeroen.mebis@jessazh.be
    • Contact: Joy Lodewijckx, drs.; Email: joy.lodewijckx@uhasselt.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Experimental: Treatment group	Device: 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 Names: Low level laser therapy
No Intervention: Control group (no intervention)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
EORTC QLQ-C30 Quality of life questionnaire	A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module	Baseline
EORTC QLQ-C30 Quality of life questionnaire	A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module	Month 1
EORTC QLQ-C30 Quality of life questionnaire	A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module	Month 2
EORTC QLQ-C30 Quality of life questionnaire	A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module	Month 3
QLQ-BR23 Quality of life questionnaire	A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module	Baseline
QLQ-BR23 Quality of life questionnaire	A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module	Month 1
QLQ-BR23 Quality of life questionnaire	A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module	Month 2
QLQ-BR23 Quality of life questionnaire	A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module	Month 3
Patient global satisfaction numerical rating scale	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)	Month 3

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: Jessa Hospital
• Investigators: Study Chair: Joy Lodewijckx, drs., Hasselt University

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2020
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: July 25, 2019
• First Submitted That Met QC Criteria: July 29, 2019
• First Posted (Actual): July 30, 2019

Study Record Updates

• Last Update Posted (Actual): March 23, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: photomodulation therapy; supportive cancer care; epirubicin cyclophosphamide
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: 19.58/ONCO19.08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No