PBMT for the Management of CIA ( HAIRLASER )

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    30
  • sponsor
    Hasselt University
Updated on 8 April 2022
paclitaxel
cancer
breast cancer
treatment regimen
docetaxel
breast adenocarcinoma
scalp cooling
taxane
anthracycline

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.

Details
Condition Breast Cancer, Chemotherapy-induced Alopecia, Alopecia
Treatment Photobiomodulation Therapy, Sham photobiomodulation therapy
Clinical Study IdentifierNCT04036994
SponsorHasselt University
Last Modified on8 April 2022

Eligibility

Yes No Not Sure

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
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
Active infection on the scalp
Chronic dermatologic condition (e.g. eczema, psoriasis, infection)
Clear my responses

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