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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04036994
Other study ID # 19.58/ONCO19.08
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 17, 2020
Est. completion date December 31, 2022

Study information

Verified date March 2022
Source Hasselt University
Contact Jeroen Mebis, prof. dr.
Phone + 32 11 33 79 79
Email jeroen.mebis@jessazh.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 31, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 5a-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 Design


Intervention

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.

Locations

Country Name City State
Belgium Jessa Ziekenhuis Hasselt

Sponsors (2)

Lead Sponsor Collaborator
Hasselt University Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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