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

Not Applicable

Recruiting

• Conditions: Radiotherapy Side Effect; Vaginal Abnormality
• Interventions: Device: Intimleds

• Registration Number: NCT05165056
• Lead Sponsor: Jessa Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2021-11-23
• Study First Submitted QC: 2021-12-06
• Study First Posted: 2021-12-21
• Study Start: 2022-08-24
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-28
• Last Update Posted: 2023-09-29
• Primary Completion: 2030-01
• Study Completion: 2030-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	Intimleds	Patients allocated to the treatment group will receive institutional standard vaginal care in combined with twice weekly PBMT sessions during the radiotherapy course and until two weeks after the end of radiotherapy.

Primary Outcome Measures

Name	Time	Method
CTCAE-score	Three months post radiotherapy	The physician will score the patient's vaginal dryness, discharge, inflammation, stricture, pain and hemorrhage according to the Common Terminology Criteria for Adverse Events (CTCAE)
RIVT symptoms	One year post radiotherapy	The patient will score their symptoms (dryness, pruritus, discharge, hemorrhage and a burning sensation) via a NRS ranging from 0 (symptom absent) to 10 (most severe form).

Secondary Outcome Measures

Name	Time	Method
Vaginal health index (VHI)	Three months post radiotherapy	A clinical exam will be performed by the physician to evaluate vaginal elasticity, vaginal secretion, pH, epithelial integrity and moisture. These five parameters will be scored on the on the VHI, from 1 (severe symptoms) to 5 (normal vaginal health). A total score can be calculated by adding the scores of the different parameters
Quality of Life score	One year post radiotherapy	The European Organization for Research and Treatment for Cancer Quality of Life Questionnaires (EORTC QLQ) will be used to assess the patients' quality of life.
Sexual distress score	One year post radiotherapy	The multidimensional, self-reported Female Sexual Distress Scale-Revised 2005 (FSDS-R) questionnaire will be used to evaluate the patient's sexual distress. This questionnaire consists of 13 items scored from 0 (never occurring) to 4 (always occurring). A score of 11 or more effectively discriminates between patients with female sexual distress and patients without distress.
Satisfaction score	One year post radiotherapy	The patients will be asked to evaluate the general pleasantness and soothing effect of the therapeutic intervention. Furthermore, they will be asked to score their global satisfaction with the therapeutic intervention. The patients will score their satisfaction regarding their treatment on the NRS scale 0 (totally not satisfied) to 10 (very satisfied).
Pain score	One year post radiotherapy	A NRS (0, no pain to 10, the most severe pain) will be used to evaluate the patient's pain level due to the RIVT.
Sexual functioning score	One year post radiotherapy	The Female Sexual Function Index (FSFI) is a multidimensional, self-reported questionnaire that evaluates the patient's sexual functioning. The questionnaire consists of 19 questions, divided into six subscales (sexual desire, sexual arousal, lubrication, orgasms, sexual gratification and pain during intercourse). The total score ranges from 2 (severely compromised sexual functioning) to 36 (excellent sexual functioning).

Trial Locations

Locations (2)

Jessa Hospital; 🇧🇪 Hasselt, Limburg, Belgium

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Limburg, Belgium