PBMT for the Management of CIA ( HAIRLASER )

Study Overview
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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.

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

Conditions
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Breast Cancer, Chemotherapy-induced Alopecia, Alopecia

Intervention / Treatment
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* Device: Photobiomodulation therapy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Experimental: Treatment group<br> | Device: Photobiomodulation therapy<br>* All patients will undergo photobiomodulation therapy sessions three times a week for the total duration of 12 weeks starting at their last CT administration.<br>* Other names: Low level laser therapy;|
| No Intervention: Control group (no intervention)<br> | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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photomodulation therapy, supportive cancer care, epirubicin cyclophosphamide