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

NCT ID: NCT05177289

Last Updated: 2023-09-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-28
• Study Completion Date: 2030-01-31

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.

Conditions

Chemotherapy-induced Alopecia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Theradome® LH80 pro

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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

Control group

Patients allocated to the control group will receive scalp cooling during their CTx course.

Group Type: ACTIVE_COMPARATOR

Scalp cooling

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Scalp cooling

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jessa Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeroen Mebis, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Jessa Hospital

Locations

Jessa Hospital

Hasselt, Limburg, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Jeroen Mebis, Prof. Dr.

Role: CONTACT

jeroen.mebis@jessazh.be

+32 11 33 72 21

Marithé Claes, MSc

Role: CONTACT

marithe.claes@uhasselt.be

+32 11 33 72 39

Facility Contacts

Jeroen Mebis, Prof. Dr.

Role: primary

jeroen.mebis@jessazh.be

+32 11 33 72 21

Marithé Marithé, MSc

Role: backup

marithe.claes@uhasselt.be

+32 11 33 72 39

References

Claes M, Robijns J, Lambrichts L, Van Duffel S, Bulens P, Mebis J. Photobiomodulation therapy in the prevention of chemotherapy-induced alopecia in breast cancer patients: a randomized controlled trial. Lasers Med Sci. 2025 Jul 24;40(1):325. doi: 10.1007/s10103-025-04577-7.

Reference Type: DERIVED

PMID: 40705170 (View on PubMed)

Other Identifiers

2021/117

Identifier Type: -

Identifier Source: org_study_id