Status:
UNKNOWN
PBMT for the Management of CIA ( HAIRLASER )
Lead Sponsor:
Hasselt University
Collaborating Sponsors:
Jessa Hospital
Conditions:
Breast Cancer
Chemotherapy-induced Alopecia
Eligibility:
FEMALE
18+ years
Phase:
NA
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-induc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04036994
Start Date
June 17 2020
End Date
December 31 2022
Last Update
March 23 2022
Active Locations (1)
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1
Jessa Ziekenhuis
Hasselt, Belgium, 3500