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

Not Applicable

Recruiting

• Conditions: Chemotherapy-induced Alopecia
• Interventions: Device: Scalp cooling; Device: Theradome® LH80 pro

• Registration Number: NCT05177289
• Lead Sponsor: Jessa Hospital

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.

Study Timeline

• Study First Submitted: 2021-12-09
• Study First Submitted QC: 2021-12-14
• Study First Posted: 2022-01-04
• Study Start: 2022-02-28
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-28
• Last Update Posted: 2023-09-29
• Primary Completion: 2025-01
• Study Completion: 2030-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Scalp cooling	Patients allocated to the control group will receive scalp cooling during their CTx course.
Treatment group	Theradome® LH80 pro	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 group	Scalp cooling	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.

Primary Outcome Measures

Name	Time	Method
CTCAE-score	One month post chemotherapy	The patient may grade their hair loss using the CTCAE criteria.
Hair loss evaluation	One month post chemotherapy	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 thickness measurement	One month post chemotherapy	The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge.

Secondary Outcome Measures

Name	Time	Method
Quality of life score	One month post chemotherapy	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	One month post chemotherapy	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).

Trial Locations

Locations (1)

Jessa Hospital; 🇧🇪 Hasselt, Limburg, Belgium