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Photobiomodulation Therapy in the Prevention and Management of Radiotherapy-induced Vaginal Toxicity

NCT05165056 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2023-09-29

No results posted yet for this study

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.

Conditions

  • Radiotherapy Side Effect
  • Vaginal Abnormality

Interventions

DEVICE

Intimleds

INTIMILEDS® is a photobiomodulation device designed for intravaginal use. It's design permits an irradiation of the whole vaginal wall, the vulva, and the cervix, with a constant intensity.

Sponsors & Collaborators

  • Ziekenhuis Oost-Limburg

    collaborator OTHER

  • Hasselt University

    collaborator OTHER

  • Jessa Hospital

    lead OTHER

Principal Investigators

  • Jeroen Mebis, Prof. Dr. · Jessa Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-24
Primary Completion
2030-01-31
Completion
2030-01-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05165056 on ClinicalTrials.gov