Photobiomodulation Therapy in the Prevention and Management of Radiotherapy-induced Vaginal Toxicity

Recruiting now · Not applicable

Conditions studied: Radiotherapy Side Effect, Vaginal Abnormality

In brief

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.

Key facts

Study ID

NCT05165056

Run by

Jessa Hospital

People needed

62

Starts

2022-08-24

Expected to finish

2030-01-01

Last updated by the study team

2023-09-29

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ziekenhuis Oost-Limburg — Genk, Limburg, Belgium (enrolling)
• Jessa Hospital — Hasselt, Limburg, Belgium (enrolling)

Full record on ClinicalTrials.gov

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