Photobiomodulation Therapy in the Prevention and Management of Radiotherapy-induced Vaginal Toxicity
Evaluating the Feasibility and Efficacy of Photobiomodulation Therapy in the Prevention and Management of Radiotherapy-induced Vaginal Toxicity: a Randomized Controlled Trial
Jessa Hospital
62 participants
Aug 24, 2022
INTERVENTIONAL
Conditions
Summary
This study aims to investigate the effectiveness of photobiomodulation therapy (PBMT) in the prevention and management of radiotherapy-induced vaginal toxicity (RIVT). Therefore, we hypothesize that PBMT can reduce the severity of RIVT in gynecological cancer patients, increasing the patient's QoL and sexual functioning.
Eligibility
Inclusion Criteria5
- Diagnosed with endometrial cancer
- Scheduled for external beam radiotherapy (EBRT), intracavitary brachytherapy (BT), or a combination
- Age ≥ 18 years
- Able to comply to the study protocol
- Able to sign written informed consent
Exclusion Criteria9
- Metastatic disease
- Pregnancy
- Diagnosis of vaginal stenosis before radiotherapy (RT)
- Previous pelvic tumor or pelvic RT
- Interruption of RT for more than five sessions
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
INTIMILEDS® is a photobiomodulation device designed for intravaginal use. It's design permits an irradiation of the whole vaginal wall, the vulva, and the cervix, with a constant intensity.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05165056