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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Hair thickness measurement [Срок оценки: Baseline]
• Hair thickness measurement [Срок оценки: Halfway into their chemotherapy (An average of 6 weeks)]
• Hair thickness measurement [Срок оценки: At the final chemotherapy session (An average of 12 weeks)]
• Hair thickness measurement [Срок оценки: One month post chemotherapy]
• CTCAE-score [Срок оценки: Baseline]
• CTCAE-score [Срок оценки: Halfway into their chemotherapy (An average of 6 weeks)]
• CTCAE-score [Срок оценки: At the final chemotherapy session (An average of 12 weeks)]
• CTCAE-score [Срок оценки: One month post chemotherapy]
• Hair loss evaluation [Срок оценки: Baseline]
• Hair loss evaluation [Срок оценки: Halfway into their chemotherapy (An average of 6 weeks)]

Вторичные конечные точки (7)

• Quality of life score [Срок оценки: Baseline]
• Quality of life score [Срок оценки: Halfway into their chemotherapy (An average of 6 weeks)]
• Quality of life score [Срок оценки: At the final chemotherapy session (An average of 12 weeks)]
• Quality of life score [Срок оценки: One month post chemotherapy]
• Satisfaction score [Срок оценки: Halfway into their chemotherapy (An average of 6 weeks)]
• Satisfaction score [Срок оценки: At the final chemotherapy session (An average of 12 weeks)]
• Satisfaction score [Срок оценки: One month post chemotherapy]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Бельгия · 1 центр

• Jessa Hospital — Hasselt

Публикации

• 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. PMID 40705170

Идентификаторы

NCT: NCT05177289 · 2021/117

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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