Photobiomodulation Therapy in the Prevention and Management of Chemotherapy-Induced Alopecia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Theradome® LH80 pro, Scalp cooling.
- Who it may be relevant to
- Registry conditions: Chemotherapy-induced Alopecia. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluating the Feasibility and Efficacy of Photobiomodulation Therapy in the Prevention and Management of Chemotherapy-induced Alopecia: a Randomized Controlled Trial
Overview
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.
Interventions
- 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. - Device Scalp cooling
Scalp cooling is a standard treatment that is applied to prevent hair loss during chemotherapy.
Primary outcome measures
- Hair thickness measurement [Time frame: Baseline]
- Hair thickness measurement [Time frame: Halfway into their chemotherapy (An average of 6 weeks)]
- Hair thickness measurement [Time frame: At the final chemotherapy session (An average of 12 weeks)]
- Hair thickness measurement [Time frame: One month post chemotherapy]
- CTCAE-score [Time frame: Baseline]
- CTCAE-score [Time frame: Halfway into their chemotherapy (An average of 6 weeks)]
- CTCAE-score [Time frame: At the final chemotherapy session (An average of 12 weeks)]
- CTCAE-score [Time frame: One month post chemotherapy]
- Hair loss evaluation [Time frame: Baseline]
- Hair loss evaluation [Time frame: Halfway into their chemotherapy (An average of 6 weeks)]
Secondary outcome measures (7)
- Quality of life score [Time frame: Baseline]
- Quality of life score [Time frame: Halfway into their chemotherapy (An average of 6 weeks)]
- Quality of life score [Time frame: At the final chemotherapy session (An average of 12 weeks)]
- Quality of life score [Time frame: One month post chemotherapy]
- Satisfaction score [Time frame: Halfway into their chemotherapy (An average of 6 weeks)]
- Satisfaction score [Time frame: At the final chemotherapy session (An average of 12 weeks)]
- Satisfaction score [Time frame: One month post chemotherapy]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Belgium · 1 center
- Jessa Hospital — Hasselt
Publications
- 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
Identifiers
NCT: NCT05177289 · 2021/117