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PBMT for the Management of CIA ( HAIRLASER )

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ClinicalTrials.gov Identifier: NCT04036994
Recruitment Status : Recruiting
First Posted : July 30, 2019
Last Update Posted : March 23, 2022
Sponsor:
Collaborator:
Jessa Hospital
Information provided by (Responsible Party):
Prof. dr. Jeroen Mebis, Hasselt University

Study Description
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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-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.

Condition or disease Intervention/treatment Phase
Breast Cancer Chemotherapy-induced Alopecia Alopecia Device: Photobiomodulation therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Photobiomodulation Therapy for the Management of Chemotherapy-induced Alopecia: a Randomized, Placebo-controlled Feasibility Trial
Actual Study Start Date : June 17, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Experimental: Treatment group 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.
Other Name: Low level laser therapy
No Intervention: Control group (no intervention)


Outcome Measures
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Primary Outcome Measures :
  1. visual analogue scale (VAS) [ Time Frame: Baseline ]
    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'.

  2. visual analogue scale (VAS) [ Time Frame: Month 1 ]
    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'.

  3. visual analogue scale (VAS) [ Time Frame: Month 2 ]
    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'.

  4. visual analogue scale (VAS) [ Time Frame: Month 3 ]
    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'.


Secondary Outcome Measures :
  1. EORTC QLQ-C30 Quality of life questionnaire [ Time Frame: Baseline ]
    A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module

  2. EORTC QLQ-C30 Quality of life questionnaire [ Time Frame: Month 1 ]
    A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module

  3. EORTC QLQ-C30 Quality of life questionnaire [ Time Frame: Month 2 ]
    A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module

  4. EORTC QLQ-C30 Quality of life questionnaire [ Time Frame: Month 3 ]
    A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module

  5. QLQ-BR23 Quality of life questionnaire [ Time Frame: Baseline ]
    A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module

  6. QLQ-BR23 Quality of life questionnaire [ Time Frame: Month 1 ]
    A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module

  7. QLQ-BR23 Quality of life questionnaire [ Time Frame: Month 2 ]
    A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module

  8. QLQ-BR23 Quality of life questionnaire [ Time Frame: Month 3 ]
    A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module

  9. Patient global satisfaction numerical rating scale [ Time Frame: Month 3 ]
    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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04036994


Contacts
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Contact: Jeroen Mebis, prof. dr. + 32 11 33 79 79 jeroen.mebis@jessazh.be
Contact: Joy Lodewijckx, drs. +32 11 33 72 30 joy.lodewijckx@uhasselt.be

Locations
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Belgium
Jessa Ziekenhuis Recruiting
Hasselt, Belgium, 3500
Contact: Jeroen Mebis, prof.dr.       jeroen.mebis@jessazh.be   
Contact: Joy Lodewijckx, drs.       joy.lodewijckx@uhasselt.be   
Sponsors and Collaborators
Hasselt University
Jessa Hospital
Investigators
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Principal Investigator: Jeroen Mebis, prof. dr. Jessa Hospital
Study Chair: Joy Lodewijckx, drs. Hasselt University
More Information
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Responsible Party: Prof. dr. Jeroen Mebis, Principal Investigator, Hasselt University
ClinicalTrials.gov Identifier: NCT04036994    
Other Study ID Numbers: 19.58/ONCO19.08
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: March 23, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. dr. Jeroen Mebis, Hasselt University:
photomodulation therapy
supportive cancer care
epirubicin cyclophosphamide
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
 Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical