RecruitingNot ApplicableNCT05177289

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

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


Sponsor

Jessa Hospital

Enrollment

72 participants

Start Date

Feb 28, 2022

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

  • 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 Criteria10

  • 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

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Interventions

DEVICETheradome® 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.

DEVICEScalp cooling

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


Locations(1)

Jessa Hospital

Hasselt, Limburg, Belgium

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NCT05177289


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