NCT05165056

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

Evaluating the Feasibility and Efficacy of Photobiomodulation Therapy in the Prevention and Management of Radiotherapy-induced Vaginal Toxicity: a Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Jessa Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The global cancer burden keeps rising, and the accompanied side effects remain a significant concern. This project focuses on one of such complications: radiotherapy-induced vaginal toxicity (RIVT). The use of external and internal radiotherapy in gynecological cancers can severely impact the patient's vaginal function. This influences the patient's quality of life (QoL), as it significantly limits sexual intercourse and further physical examination. Management of RIVT urgently requires a comprehensive approach. Photobiomodulation therapy (PBMT) is a non-invasive form of phototherapy that utilizes visible and/or near-infrared light to trigger a cascade of intracellular reactions. PBMT can be used to improve wound healing, and to reduce pain, inflammation, and edema. Literature shows that PBMT can be used for treating the genitourinary syndrome of menopause as it stimulates the synthesis of collagen and elastin and promotes vasodilation in the vaginal submucosa. To date, no clinical trials have investigated the positive effects of PBMT on RIVT.

Conditions

• Radiotherapy Side Effect
• Vaginal Abnormality

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-24
• Primary completion: 2030-01-01
• Completion: 2030-01-01
• First posted: 2021-12-21
• Last updated: 2023-09-29

Locations

2 sites across 1 country: Belgium