PBMT for the Management of CIA ( HAIRLASER )

NCT ID: NCT04036994

Last Updated: 2022-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-17

Study Completion Date

2022-12-31

Brief Summary

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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

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Conditions

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Breast Cancer Chemotherapy-induced Alopecia Alopecia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental: Treatment group

Group Type ACTIVE_COMPARATOR

Photobiomodulation therapy

Intervention Type DEVICE

All patients will undergo photobiomodulation therapy sessions three times a week for the total duration of 12 weeks starting at their last CT administration.

Control group (no intervention)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Low level laser therapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Jessa Hospital

OTHER

Sponsor Role collaborator

Hasselt University

OTHER

Sponsor Role lead

Responsible Party

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Prof. dr. Jeroen Mebis

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeroen Mebis, prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Jessa Hospital

Joy Lodewijckx, drs.

Role: STUDY_CHAIR

Hasselt University

Locations

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Jessa Ziekenhuis

Hasselt, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Jeroen Mebis, prof. dr.

Role: CONTACT

+ 32 11 33 79 79

Joy Lodewijckx, drs.

Role: CONTACT

+32 11 33 72 30

Facility Contacts

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Jeroen Mebis, prof.dr.

Role: primary

Joy Lodewijckx, drs.

Role: backup

References

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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.

Reference Type DERIVED
PMID: 37060420 (View on PubMed)

Other Identifiers

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19.58/ONCO19.08

Identifier Type: -

Identifier Source: org_study_id

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