Photobiomodulation Therapy in the Prevention and Management of Radiotherapy-induced Vaginal Toxicity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorJessa Hospital
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Metastatic disease
Pregnancy
Diagnosis of vaginal stenosis before radiotherapy (RT)
Previous pelvic tumor or pelvic RT
Trial design
Design model
Parallel
Treatments tested in this trial
Intimleds
DeviceINTIMILEDS® 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.
Treatment groups
62 Participants
are divided into 2 treatment groupsGroup A: Treatment groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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)
Time frame
Baseline2
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)
Time frame
Two weeks post radiotherapy3
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)
Time frame
Three months post radiotherapy4
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).
Time frame
BaselineSecondary outcomes
1
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
Time frame
Baseline2
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
Time frame
Two weeks post radiotherapy3
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
Time frame
Three months post radiotherapy4
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.
Time frame
BaselineOther outcomes
1
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).
Time frame
Baseline2
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).
Time frame
Three months post radiotherapy3
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).
Time frame
One year post radiotherapy4
Cancer relapse or recurrence
The posibility of cancer relapse or recurrence will be evaluated using the patients' medical records.
Time frame
One year post radiotherapySponsors and contacts
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Source ClinicalTrials.gov