Actively Recruiting
Photobiomodulation Therapy in the Prevention and Management of Radiotherapy-induced Vaginal Toxicity
Led by Jessa Hospital · Updated on 2023-09-29
62
Participants Needed
2
Research Sites
383 weeks
Total Duration
On this page
Sponsors
J
Jessa Hospital
Lead Sponsor
Z
Ziekenhuis Oost-Limburg
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Photobiomodulation Therapy in the Prevention and Management of Radiotherapy-induced Vaginal Toxicity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with endometrial cancer
- Scheduled for external beam radiotherapy (EBRT), intracavitary brachytherapy (BT), or a combination
- Age 18 years or older
- Able to comply with the study protocol
- Able to sign written informed consent
You will not qualify if you...
- Metastatic disease
- Pregnancy
- Diagnosis of vaginal stenosis before radiotherapy (RT)
- Previous pelvic tumor or pelvic radiotherapy
- Interruption of radiotherapy for more than five sessions
- Severe psychological disorder or dementia
- Inability to speak and understand Dutch
- Substance abuse or medical, psychological, or social conditions interfering with participation or study evaluation
- Any unstable condition affecting patient safety or study compliance as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Ziekenhuis Oost-Limburg
Genk, Limburg, Belgium, 3600
Actively Recruiting
2
Jessa Hospital
Hasselt, Limburg, Belgium, 3500
Actively Recruiting
Research Team
J
Jeroen Mebis, Prof. Dr.
CONTACT
M
Marithé Claes, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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