NCT05165056 Photobiomodulation Therapy in the Prevention and Management of Radiotherapy-induced Vaginal Toxicity
| NCT ID | NCT05165056 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jessa Hospital |
| Condition | Radiotherapy Side Effect |
| Study Type | INTERVENTIONAL |
| Enrollment | 62 participants |
| Start Date | 2022-08-24 |
| Primary Completion | 2030-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 62 participants in total. It began in 2022-08-24 with a primary completion date of 2030-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Jeroen Mebis, Prof. Dr.
PRINCIPAL INVESTIGATOR
Jessa Hospital
Frequently Asked Questions
Who can join the NCT05165056 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Radiotherapy Side Effect. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05165056 currently recruiting?
Yes, NCT05165056 is actively recruiting participants. Contact the research team at jeroen.mebis@jessazh.be for enrollment information.
Where is the NCT05165056 trial being conducted?
This trial is being conducted at Genk, Belgium, Hasselt, Belgium.
Who is sponsoring the NCT05165056 clinical trial?
NCT05165056 is sponsored by Jessa Hospital. The principal investigator is Jeroen Mebis, Prof. Dr. at Jessa Hospital. The trial plans to enroll 62 participants.