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

Chemotherapy-induced Alopecia Clinical Trial

— HairLight  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05177289
• Other study ID #: 2021/117
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2022
• Est. completion date: January 2030

Study information

• Verified date: September 2023
• Source: Jessa Hospital
• Contact: Jeroen Mebis, Prof. Dr.
• Phone: +32 11 33 72 21
• Email: jeroen.mebis[@]jessazh.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: January 2030
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Chemotherapy-induced Alopecia

Intervention

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.
• Scalp cooling
Scalp cooling is a standard treatment that is applied to prevent hair loss during chemotherapy.

Locations

Country	Name	City	State
Belgium	Jessa Hospital	Hasselt	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Cancer relapse or recurrence	The posibility of cancer relapse or recurrence will be evaluated using the patients' medical records.	One year post chemotherapy
Other	Cancer relapse or recurrence	The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.	Two years post chemotherapy
Other	Cancer relapse or recurrence	The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.	Three years post chemotherapy
Other	Cancer relapse or recurrence	The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.	Four years post chemotherapy
Other	Cancer relapse or recurrence	The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.	Five years post chemotherapy
Primary	Hair thickness measurement	The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge.	Baseline
Primary	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)
Primary	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)
Primary	Hair thickness measurement	The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge.	One month post chemotherapy
Primary	CTCAE-score	The patient may grade their hair loss using the CTCAE criteria.	Baseline
Primary	CTCAE-score	The patient may grade their hair loss using the CTCAE criteria.	Halfway into their chemotherapy (An average of 6 weeks)
Primary	CTCAE-score	The patient may grade their hair loss using the CTCAE criteria.	At the final chemotherapy session (An average of 12 weeks)
Primary	CTCAE-score	The patient may grade their hair loss using the CTCAE criteria.	One month post chemotherapy
Primary	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
Primary	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)
Primary	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)
Primary	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	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
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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