Using light therapy to prevent and manage vaginal issues from radiotherapy
Official title: Evaluating the Feasibility and Efficacy of Photobiomodulation Therapy in the Prevention and Management of Radiotherapy-induced Vaginal Toxicity: a Randomized Controlled Trial
Run by Jessa Hospital · NCT05165056 · Data updated 2026-11-12
This study is testing if light therapy can help women with gynecological cancers prevent and manage vaginal problems caused by radiotherapy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 62 (estimated) |
| Sponsor | Jessa Hospital Academic / other |
| Locations | 2 sites (Genk, Limburg and 1 other locations) |
| Status | Recruiting |
| Started | August 24, 2022 |
| Main results expected | January 2030 |
| Study ends | January 2030 |
| Registry record updated | September 29, 2023 |
| Trial ID | NCT05165056 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adult women diagnosed with endometrial cancer who are scheduled to undergo radiotherapy.
✕Probably not a fit
Patients with metastatic disease, pregnancy, or pre-existing vaginal stenosis prior to radiotherapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effectiveness of photobiomodulation therapy (PBMT) in preventing and managing radiotherapy-induced vaginal toxicity (RIVT) in patients with gynecological cancers. The approach involves using non-invasive light therapy to enhance healing and reduce symptoms associated with RIVT, which can significantly affect quality of life and sexual functioning. The study aims to provide a comprehensive management strategy for patients undergoing radiotherapy, focusing on improving their overall well-being. By exploring the potential benefits of PBMT, the research seeks to fill a gap in current treatment options for RIVT.
Why it matters
Potential benefit: If successful, this therapy could significantly improve the quality of life and sexual functioning for patients suffering from radiotherapy-induced vaginal toxicity.
How similar studies have gone: While no clinical trials have specifically investigated PBMT for RIVT, existing literature suggests its effectiveness in treating related conditions, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Ziekenhuis Oost-Limburg
Genk, Limburg, Belgium Recruiting -
Jessa Hospital
Hasselt, Limburg, Belgium Recruiting
Study contacts
- Principal investigator: Jeroen Mebis, Prof. Dr. — Jessa Hospital
- Study coordinator: Jeroen Mebis, Prof. Dr.
- Email: jeroen.mebis@jessazh.be
- Phone: +32 11 33 72 21
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.