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

Last updated: September 28, 2023
Sponsor: Jessa Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hair Loss

Alopecia

Treatment

Theradome® LH80 pro

Scalp cooling

Clinical Study ID

NCT05177289
2021/117
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed with gynecological cancer (endometrium, cervix, ovarian or vulva) or breastcancer
  • Receiving chemotherapy ((Carbo)-Taxol)
  • Age ≥ 18 years
  • Able to comply to the study protocol
  • Able to sign written informed consent

Exclusion

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 conditionsthat may interfere with the patient's participation in the study or evaluation of thestudy results as judged by the investigator
  • Any condition that is unstable or could affect the safety of the patient and theircompliance in the study as judged by the investigator

Study Design

Total Participants: 72
Treatment Group(s): 2
Primary Treatment: Theradome® LH80 pro
Phase:
Study Start date:
February 28, 2022
Estimated Completion Date:
January 31, 2030

Study 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.

Connect with a study center

  • Jessa Hospital

    Hasselt, Limburg 3500
    Belgium

    Active - Recruiting

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