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PBMT for the Management of CIA ( HAIRLASER )

Primary Purpose

Breast Cancer, Chemotherapy-induced Alopecia, Alopecia

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Photobiomodulation therapy
Sponsored by
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring photomodulation therapy, supportive cancer care, epirubicin cyclophosphamide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Jessa ZiekenhuisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Experimental: Treatment group

Control group (no intervention)

Arm Description

Outcomes

Primary Outcome Measures

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'.
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'.
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'.
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'.

Secondary Outcome Measures

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
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
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
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
QLQ-BR23 Quality of life questionnaire
A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module
QLQ-BR23 Quality of life questionnaire
A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module
QLQ-BR23 Quality of life questionnaire
A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module
QLQ-BR23 Quality of life questionnaire
A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module
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)

Full Information

First Posted
July 25, 2019
Last Updated
March 8, 2022
Sponsor
Hasselt University
Collaborators
Jessa Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04036994
Brief Title
PBMT for the Management of CIA ( HAIRLASER )
Official Title
Photobiomodulation Therapy for the Management of Chemotherapy-induced Alopecia: a Randomized, Placebo-controlled Feasibility Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 17, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
Jessa Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Chemotherapy-induced Alopecia, Alopecia
Keywords
photomodulation therapy, supportive cancer care, epirubicin cyclophosphamide

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Treatment group
Arm Type
Active Comparator
Arm Title
Control group (no intervention)
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Photobiomodulation therapy
Other Intervention Name(s)
Low level laser therapy
Intervention Description
All patients will undergo photobiomodulation therapy sessions three times a week for the total duration of 12 weeks starting at their last CT administration.
Primary Outcome Measure Information:
Title
visual analogue scale (VAS)
Description
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'.
Time Frame
Baseline
Title
visual analogue scale (VAS)
Description
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'.
Time Frame
Month 1
Title
visual analogue scale (VAS)
Description
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'.
Time Frame
Month 2
Title
visual analogue scale (VAS)
Description
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'.
Time Frame
Month 3
Secondary Outcome Measure Information:
Title
EORTC QLQ-C30 Quality of life questionnaire
Description
A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module
Time Frame
Baseline
Title
EORTC QLQ-C30 Quality of life questionnaire
Description
A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module
Time Frame
Month 1
Title
EORTC QLQ-C30 Quality of life questionnaire
Description
A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module
Time Frame
Month 2
Title
EORTC QLQ-C30 Quality of life questionnaire
Description
A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module
Time Frame
Month 3
Title
QLQ-BR23 Quality of life questionnaire
Description
A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module
Time Frame
Baseline
Title
QLQ-BR23 Quality of life questionnaire
Description
A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module
Time Frame
Month 1
Title
QLQ-BR23 Quality of life questionnaire
Description
A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module
Time Frame
Month 2
Title
QLQ-BR23 Quality of life questionnaire
Description
A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module
Time Frame
Month 3
Title
Patient global satisfaction numerical rating scale
Description
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)
Time Frame
Month 3

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeroen Mebis, prof. dr.
Phone
+ 32 11 33 79 79
Email
jeroen.mebis@jessazh.be
First Name & Middle Initial & Last Name or Official Title & Degree
Joy Lodewijckx, drs.
Phone
+32 11 33 72 30
Email
joy.lodewijckx@uhasselt.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeroen Mebis, prof. dr.
Organizational Affiliation
Jessa Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joy Lodewijckx, drs.
Organizational Affiliation
Hasselt University
Official's Role
Study Chair
Facility Information:
Facility Name
Jessa Ziekenhuis
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeroen Mebis, prof.dr.
Email
jeroen.mebis@jessazh.be
First Name & Middle Initial & Last Name & Degree
Joy Lodewijckx, drs.
Email
joy.lodewijckx@uhasselt.be

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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PBMT for the Management of CIA ( HAIRLASER )

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