Photobiomodulation Therapy in the Prevention and Management of Chemotherapy-Induced Alopecia (HairLight)

Evaluating the Feasibility and Efficacy of Photobiomodulation Therapy in the Prevention and Management of Chemotherapy-induced Alopecia: a Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Chemotherapy-induced Alopecia
• Intervention / Treatment: Device: Theradome® LH80 pro; Device: Scalp cooling

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.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeroen Mebis, Prof. Dr.; Phone Number: +32 11 33 72 21; Email: jeroen.mebis@jessazh.be
• Study Contact Backup: Name: Marithé Claes, MSc; Phone Number: +32 11 33 72 39; Email: marithe.claes@uhasselt.be

Study Locations

• Belgium
  • Limburg
    • Hasselt, Limburg, Belgium, 3500
      • Recruiting
      • Jessa Hospital
      • Contact: Jeroen Mebis, Prof. Dr.; Phone Number: +32 11 33 72 21; Email: jeroen.mebis@jessazh.be
      • Contact: Marithé Marithé, MSc; Phone Number: +32 11 33 72 39; Email: marithe.claes@uhasselt.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; 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.	Device: Theradome® LH80 pro; 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.; Device: Scalp cooling; Scalp cooling is a standard treatment that is applied to prevent hair loss during chemotherapy.
Active Comparator: Control group; Patients allocated to the control group will receive scalp cooling during their CTx course.	Device: Scalp cooling; Scalp cooling is a standard treatment that is applied to prevent hair loss during chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hair thickness measurement	The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge.	Baseline
Hair thickness measurement	The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge.	Halfway into their chemotherapy (An average of 6 weeks)
Hair thickness measurement	The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge.	At the final chemotherapy session (An average of 12 weeks)
Hair thickness measurement	The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge.	One month post chemotherapy
CTCAE-score	The patient may grade their hair loss using the CTCAE criteria.	Baseline
CTCAE-score	The patient may grade their hair loss using the CTCAE criteria.	Halfway into their chemotherapy (An average of 6 weeks)
CTCAE-score	The patient may grade their hair loss using the CTCAE criteria.	At the final chemotherapy session (An average of 12 weeks)
CTCAE-score	The patient may grade their hair loss using the CTCAE criteria.	One month post chemotherapy
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'.	Baseline
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'.	Halfway into their chemotherapy (An average of 6 weeks)
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'.	At the final chemotherapy session (An average of 12 weeks)
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'.	One month post chemotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline
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.	Halfway into their chemotherapy (An average of 6 weeks)
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.	At the final chemotherapy session (An average of 12 weeks)
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.	One month post chemotherapy
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).	Halfway into their chemotherapy (An average of 6 weeks)
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).	At the final chemotherapy session (An average of 12 weeks)
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).	One month post chemotherapy

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
General patient-, disease-, and treatment-related information	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).	Baseline
General patient-, disease-, and treatment-related information	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).	One month post chemotherapy
Cancer relapse or recurrence	The posibility of cancer relapse or recurrence will be evaluated using the patients' medical records.	One year post chemotherapy
Cancer relapse or recurrence	The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.	Two years post chemotherapy
Cancer relapse or recurrence	The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.	Three years post chemotherapy
Cancer relapse or recurrence	The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.	Four years post chemotherapy
Cancer relapse or recurrence	The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.	Five years post chemotherapy

Collaborators and Investigators

• Sponsor: Jessa Hospital
• Investigators: Principal Investigator: Jeroen Mebis, Prof. Dr., Jessa Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2022
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: December 9, 2021
• First Submitted That Met QC Criteria: December 14, 2021
• First Posted (Actual): January 4, 2022

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Photobiomodulation therapy
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: 2021/117

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No