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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Radiotherapy Side Effect; Vaginal Abnormality
• Intervention / Treatment: Device: Intimleds

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 Type: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeroen Mebis, Prof. Dr.; Phone Number: +32 11 33 72 21; Email: jeroen.mebis@jessazh.be
• Study Contact Backup: Name: Marithé Claes, MSc; Phone Number: +32 11 33 72 39; Email: marithe.claes@uhasselt.be

Study Locations

• Belgium
  • Limburg
    • Genk, Limburg, Belgium, 3600
      • Recruiting
      • Ziekenhuis Oost-Limburg
      • Contact: Evelyn Van de Werf, Dr.; Phone Number: +32 89 32 65 61; Email: Evelyn.VandeWerf@zol.be
      • Contact: Marithé Claes, MSc; Phone Number: +32 11 33 72 39; Email: marithe.claes@uhasselt.be
    • Hasselt, Limburg, Belgium, 3500
      • Recruiting
      • Jessa Hospital
      • Sub-Investigator: Philippe Bulens, Dr.
      • Contact: Jeroen Mebis, Prof. Dr.; Phone Number: +32 11 33 72 21; Email: jeroen.mebis@jessazh.be
      • Contact: Marithé Marithé, MSc; Phone Number: +32 11 33 72 39; Email: marithe.claes@uhasselt.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; 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.	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.
No Intervention: Control group; Patients allocated to the control group will receive institutional standard vaginal care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CTCAE-score	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)	Baseline
CTCAE-score	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)	Two weeks post radiotherapy
CTCAE-score	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)	Three months post radiotherapy
RIVT symptoms	The patient will score their symptoms (dryness, pruritus, discharge, hemorrhage and a burning sensation) via a numeric rating scale (NRS) ranging from 0 (symptom absent) to 10 (most severe form).	Baseline
RIVT symptoms	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).	Final radiotherapy session
RIVT symptoms	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).	Two weeks post radiotherapy
RIVT symptoms	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).	Three months post radiotherapy
RIVT symptoms	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).	One year post radiotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaginal health index (VHI)	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	Baseline
Vaginal health index (VHI)	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	Two weeks post radiotherapy
Vaginal health index (VHI)	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	Three months post radiotherapy
Pain score	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.	Baseline
Pain score	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.	Two weeks post radiotherapy
Pain score	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.	Three months post radiotherapy
Pain score	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.	One year post radiotherapy
Quality of Life score	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).	Baseline
Quality of Life score	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.	Two weeks post radiotherapy
Quality of Life score	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.	Three months post radiotherapy
Quality of Life score	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.	One year post radiotherapy
Sexual functioning score	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).	Baseline
Sexual functioning score	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).	Two weeks post radiotherapy
Sexual functioning score	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).	Three months post radiotherapy
Sexual functioning score	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).	One year post radiotherapy
Sexual distress score	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.	Baseline
Sexual distress score	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.	Two weeks post radiotherapy
Sexual distress score	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.	Three months post radiotherapy
Sexual distress score	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.	One year post radiotherapy
Satisfaction score	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).	Two weeks post radiotherapy
Satisfaction score	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).	Three months post radiotherapy
Satisfaction score	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).	One year post radiotherapy

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
General patient-, disease-, and treatment-related information	General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (e.g. age and smoking history). Information regarding the disease- and treatment-related risk factors will be collected through medical records (e.g., tumour type and stage).	Baseline
General patient-, disease-, and treatment-related information	General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (e.g. age and smoking history). Information regarding the disease- and treatment-related risk factors will be collected through medical records (e.g., tumour type and stage).	Three months post radiotherapy
General patient-, disease-, and treatment-related information	General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (e.g. age and smoking history). Information regarding the disease- and treatment-related risk factors will be collected through medical records (e.g., tumour type and stage).	One year post radiotherapy
Cancer relapse or recurrence	The posibility of cancer relapse or recurrence will be evaluated using the patients' medical records.	One year post radiotherapy
Cancer relapse or recurrence	The posibility of cancer relapse or recurrence will be evaluated using the patients' medical records.	Two years post radiotherapy
Cancer relapse or recurrence	The posibility of cancer relapse or recurrence will be evaluated using the patients' medical records.	Three years post radiotherapy
Cancer relapse or recurrence	The posibility of cancer relapse or recurrence will be evaluated using the patients' medical records.	Four years post radiotherapy
Cancer relapse or recurrence	The posibility of cancer relapse or recurrence will be evaluated using the patients' medical records.	Five years post radiotherapy
Radiotherapy dose	During the delineation for RT planning, a vaginal reference point will be constructed. An anatomical vaginal reference point was defined at the level of the Posterior-Inferior Border of Symphysis (PIBS), plus two points ±2 cm (mid/introitus vagina). For BT extra points were selected for the upper vagina at 12/3/6/9 o'clock, at the vaginal surface and 5 mm depth. Dose reporting to these vaginal reference points will be done and the dose to these reference points will then be correlated with RIVT.	Final radiotherapy session

Collaborators and Investigators

• Sponsor: Jessa Hospital
• Collaborators: Hasselt University; Ziekenhuis Oost-Limburg
• Investigators: Principal Investigator: Jeroen Mebis, Prof. Dr., Jessa Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2022
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: November 23, 2021
• First Submitted That Met QC Criteria: December 6, 2021
• First Posted (Actual): December 21, 2021

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Photobiomodulation therapy
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: 2021/099

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No