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

Jessa Hospital

Status: Enrolling

Conditions: Chemotherapy-induced Alopecia

Treatments: Device: Theradome® LH80 pro; Device: Scalp cooling

Study type: Interventional

Funder types: Other

Identifiers

NCT05177289

2021/117

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 2 patient groups

Treatment group

Experimental group

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.

Treatment:

Device: Scalp cooling

Device: Theradome® LH80 pro

Control group

Active Comparator group

Description:

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

Treatment:

Device: Scalp cooling