Back to resultsPhotobiomodulation Therapy in the Prevention and Management of Chemotherapy-Induced Alopecia (HairLight)
Primary Purpose
Chemotherapy-induced Alopecia
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Theradome® LH80 pro
Scalp cooling
Sponsored by
About this trial
This is an interventional prevention trial for Chemotherapy-induced Alopecia focused on measuring Photobiomodulation therapy
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with gynecological cancer (endometrium, cervix, ovarian or vulva) or breast cancer
- Receiving chemotherapy ((Carbo)-Taxol)
- Age ≥ 18 years
- Able to comply to the study protocol
- Able to sign written informed consent
Exclusion Criteria:
- Metastatic disease
- Pregnancy
- Active infection of the scalp
- Previous diagnosis of a hair loss condition
- Interruption of chemotherapy for more than two consecutive cycles
- Medication to stimulate hair growth (e.g., Minoxidil)
- Severe psychological disorder or dementia.
- Inability to speak and understand Dutch
- Substance abuse patients or patients with medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results as judged by the investigator
- Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator
Sites / Locations
- Jessa HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment group
Control group
Arm Description
Patients allocated to the treatment group will receive scalp cooling combined with thrice weekly PBM sessions during the CTx course and until one month after the end of CTx.
Patients allocated to the control group will receive scalp cooling during their CTx course.
Outcomes
Primary Outcome Measures
Hair thickness measurement
The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge.
Hair thickness measurement
The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge.
Hair thickness measurement
The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge.
Hair thickness measurement
The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge.
CTCAE-score
The patient may grade their hair loss using the CTCAE criteria.
CTCAE-score
The patient may grade their hair loss using the CTCAE criteria.
CTCAE-score
The patient may grade their hair loss using the CTCAE criteria.
CTCAE-score
The patient may grade their hair loss using the CTCAE criteria.
Hair loss evaluation
Both the patient and a blinded study nurse will score hair regrowth based on photographs. A score of 0 equals 'total baldness' and 10 'full scalp coverage'.
Hair loss evaluation
Both the patient and a blinded study nurse will score hair regrowth based on photographs. A score of 0 equals 'total baldness' and 10 'full scalp coverage'.
Hair loss evaluation
Both the patient and a blinded study nurse will score hair regrowth based on photographs. A score of 0 equals 'total baldness' and 10 'full scalp coverage'.
Hair loss evaluation
Both the patient and a blinded study nurse will score hair regrowth based on photographs. A score of 0 equals 'total baldness' and 10 'full scalp coverage'.
Secondary Outcome Measures
Quality of life score
The European Organization for Research and Treatment for Cancer Quality of Life Questionnaire will be used to evaluate the patients' quality of life.
Quality of life score
The European Organization for Research and Treatment for Cancer Quality of Life Questionnaire will be used to evaluate the patients' quality of life.
Quality of life score
The European Organization for Research and Treatment for Cancer Quality of Life Questionnaire will be used to evaluate the patients' quality of life.
Quality of life score
The European Organization for Research and Treatment for Cancer Quality of Life Questionnaire will be used to evaluate the patients' quality of life.
Satisfaction score
The patients will be asked to evaluate their global satisfaction with the therapeutic intervention. The patients will score their satisfaction regarding their treatment on the NRS scale 0 (totally not satisfied) to 10 (very satisfied).
Satisfaction score
The patients will be asked to evaluate their global satisfaction with the therapeutic intervention. The patients will score their satisfaction regarding their treatment on the NRS scale 0 (totally not satisfied) to 10 (very satisfied).
Satisfaction score
The patients will be asked to evaluate their global satisfaction with the therapeutic intervention. The patients will score their satisfaction regarding their treatment on the NRS scale 0 (totally not satisfied) to 10 (very satisfied).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05177289
Brief Title
Photobiomodulation Therapy in the Prevention and Management of Chemotherapy-Induced Alopecia
Acronym
HairLight
Official Title
Evaluating the Feasibility and Efficacy of Photobiomodulation Therapy in the Prevention and Management of Chemotherapy-induced Alopecia: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2022 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
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
Yes
5. Study Description
Brief Summary
This study aims to investigate the effectiveness of photobiomodulation therapy (PBM) in the prevention and management of chemotherapy-induced alopecia (CIA). Therefore, we hypothesize that PBMT can reduce the severity of CIA in gynecological and breast cancer patients, increasing the patient's QoL.
Detailed Description
The global cancer burden keeps rising, and the accompanied side effects remain a significant concern. This project focuses on one of such complications: chemotherapy-induced alopecia (CIA). 65% of cancer patients receiving cytotoxic drugs experience CIA, which negatively impacts their QoL, as hair loss is often associated with impaired body image and increased depression rates. Up to now, prevention of CIA is based on scalp cooling, but this treatment has a highly variable success rate. Photobiomodulation (PBM) therapy is a non-invasive form of phototherapy that utilizes visible and/or near-infrared light to trigger a cascade of intracellular reactions. PBM can be used to improve wound healing, and to reduce pain, inflammation, and edema. Research shows that PBM can stimulate hair growth by increasing the blood flow to the scalp and stimulating the catagen or telogen metabolism of the hair follicle. However, the effect of PBM on CIA has not been adequately investigated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Alopecia
Keywords
Photobiomodulation therapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Patients allocated to the treatment group will receive scalp cooling combined with thrice weekly PBM sessions during the CTx course and until one month after the end of CTx.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients allocated to the control group will receive scalp cooling during their CTx course.
Intervention Type
Device
Intervention Name(s)
Theradome® LH80 pro
Intervention Description
The Theradome LH80 pro is a wearable laser helmet device, which uses red laser light to stop hair loss, thicken existing hair and stimulate the growth of new hair.
Intervention Type
Device
Intervention Name(s)
Scalp cooling
Intervention Description
Scalp cooling is a standard treatment that is applied to prevent hair loss during chemotherapy.
Primary Outcome Measure Information:
Title
Hair thickness measurement
Description
The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge.
Time Frame
Baseline
Title
Hair thickness measurement
Description
The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge.
Time Frame
Halfway into their chemotherapy (An average of 6 weeks)
Title
Hair thickness measurement
Description
The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge.
Time Frame
At the final chemotherapy session (An average of 12 weeks)
Title
Hair thickness measurement
Description
The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge.
Time Frame
One month post chemotherapy
Title
CTCAE-score
Description
The patient may grade their hair loss using the CTCAE criteria.
Time Frame
Baseline
Title
CTCAE-score
Description
The patient may grade their hair loss using the CTCAE criteria.
Time Frame
Halfway into their chemotherapy (An average of 6 weeks)
Title
CTCAE-score
Description
The patient may grade their hair loss using the CTCAE criteria.
Time Frame
At the final chemotherapy session (An average of 12 weeks)
Title
CTCAE-score
Description
The patient may grade their hair loss using the CTCAE criteria.
Time Frame
One month post chemotherapy
Title
Hair loss evaluation
Description
Both the patient and a blinded study nurse will score hair regrowth based on photographs. A score of 0 equals 'total baldness' and 10 'full scalp coverage'.
Time Frame
Baseline
Title
Hair loss evaluation
Description
Both the patient and a blinded study nurse will score hair regrowth based on photographs. A score of 0 equals 'total baldness' and 10 'full scalp coverage'.
Time Frame
Halfway into their chemotherapy (An average of 6 weeks)
Title
Hair loss evaluation
Description
Both the patient and a blinded study nurse will score hair regrowth based on photographs. A score of 0 equals 'total baldness' and 10 'full scalp coverage'.
Time Frame
At the final chemotherapy session (An average of 12 weeks)
Title
Hair loss evaluation
Description
Both the patient and a blinded study nurse will score hair regrowth based on photographs. A score of 0 equals 'total baldness' and 10 'full scalp coverage'.
Time Frame
One month post chemotherapy
Secondary Outcome Measure Information:
Title
Quality of life score
Description
The European Organization for Research and Treatment for Cancer Quality of Life Questionnaire will be used to evaluate the patients' quality of life.
Time Frame
Baseline
Title
Quality of life score
Description
The European Organization for Research and Treatment for Cancer Quality of Life Questionnaire will be used to evaluate the patients' quality of life.
Time Frame
Halfway into their chemotherapy (An average of 6 weeks)
Title
Quality of life score
Description
The European Organization for Research and Treatment for Cancer Quality of Life Questionnaire will be used to evaluate the patients' quality of life.
Time Frame
At the final chemotherapy session (An average of 12 weeks)
Title
Quality of life score
Description
The European Organization for Research and Treatment for Cancer Quality of Life Questionnaire will be used to evaluate the patients' quality of life.
Time Frame
One month post chemotherapy
Title
Satisfaction score
Description
The patients will be asked to evaluate their global satisfaction with the therapeutic intervention. The patients will score their satisfaction regarding their treatment on the NRS scale 0 (totally not satisfied) to 10 (very satisfied).
Time Frame
Halfway into their chemotherapy (An average of 6 weeks)
Title
Satisfaction score
Description
The patients will be asked to evaluate their global satisfaction with the therapeutic intervention. The patients will score their satisfaction regarding their treatment on the NRS scale 0 (totally not satisfied) to 10 (very satisfied).
Time Frame
At the final chemotherapy session (An average of 12 weeks)
Title
Satisfaction score
Description
The patients will be asked to evaluate their global satisfaction with the therapeutic intervention. The patients will score their satisfaction regarding their treatment on the NRS scale 0 (totally not satisfied) to 10 (very satisfied).
Time Frame
One month post chemotherapy
Other Pre-specified Outcome Measures:
Title
General patient-, disease-, and treatment-related information
Description
General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (e.g. age and smoking history). Information regarding the disease- and treatment-related risk factors will be collected through medical records (e.g., tumour type and stage).
Time Frame
Baseline
Title
General patient-, disease-, and treatment-related information
Description
General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (e.g. age and smoking history). Information regarding the disease- and treatment-related risk factors will be collected through medical records (e.g., tumour type and stage).
Time Frame
One month post chemotherapy
Title
Cancer relapse or recurrence
Description
The posibility of cancer relapse or recurrence will be evaluated using the patients' medical records.
Time Frame
One year post chemotherapy
Title
Cancer relapse or recurrence
Description
The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.
Time Frame
Two years post chemotherapy
Title
Cancer relapse or recurrence
Description
The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.
Time Frame
Three years post chemotherapy
Title
Cancer relapse or recurrence
Description
The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.
Time Frame
Four years post chemotherapy
Title
Cancer relapse or recurrence
Description
The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.
Time Frame
Five years post chemotherapy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with gynecological cancer (endometrium, cervix, ovarian or vulva) or breast cancer
Receiving chemotherapy ((Carbo)-Taxol)
Age ≥ 18 years
Able to comply to the study protocol
Able to sign written informed consent
Exclusion Criteria:
Metastatic disease
Pregnancy
Active infection of the scalp
Previous diagnosis of a hair loss condition
Interruption of chemotherapy for more than two consecutive cycles
Medication to stimulate hair growth (e.g., Minoxidil)
Severe psychological disorder or dementia.
Inability to speak and understand Dutch
Substance abuse patients or patients with medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results as judged by the investigator
Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeroen Mebis, Prof. Dr.
Phone
+32 11 33 72 21
Email
jeroen.mebis@jessazh.be
First Name & Middle Initial & Last Name or Official Title & Degree
Marithé Claes, MSc
Phone
+32 11 33 72 39
Email
marithe.claes@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
Facility Information:
Facility Name
Jessa Hospital
City
Hasselt
State/Province
Limburg
ZIP/Postal Code
3500
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeroen Mebis, Prof. Dr.
Phone
+32 11 33 72 21
Email
jeroen.mebis@jessazh.be
First Name & Middle Initial & Last Name & Degree
Marithé Marithé, MSc
Phone
+32 11 33 72 39
Email
marithe.claes@uhasselt.be
12. IPD Sharing Statement
Learn more about this trial
Photobiomodulation Therapy in the Prevention and Management of Chemotherapy-Induced Alopecia
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