Using light therapy to prevent and manage vaginal issues from radiotherapy
Evaluating the Feasibility and Efficacy of Photobiomodulation Therapy in the Prevention and Management of Radiotherapy-induced Vaginal Toxicity: a Randomized Controlled Trial
NA · Jessa Hospital · NCT05165056
This study is testing if light therapy can help women with gynecological cancers prevent and manage vaginal problems caused by radiotherapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Jessa Hospital (other) |
| Locations | 2 sites (Genk, Limburg and 1 other locations) |
| Trial ID | NCT05165056 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adult women diagnosed with endometrial cancer who are scheduled to undergo radiotherapy.
Not a fit: Patients with metastatic disease, pregnancy, or pre-existing vaginal stenosis prior to radiotherapy may not benefit from this study.
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 performed: While no clinical trials have specifically investigated PBMT for RIVT, existing literature suggests its effectiveness in treating related conditions, indicating potential for success.
Eligibility criteria
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 this trial is running
Genk, Limburg and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Radiotherapy Side Effect, Vaginal Abnormality, Photobiomodulation therapy