Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT05165056

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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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