An interventional study of Intimleds in Radiotherapy Side Effect and Vaginal Abnormality, sponsored by Jessa Hospital. Recruiting at 2 sites in Belgium. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-29.
Sponsored by Jessa Hospital · Not applicable, Interventional, and Prevention
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.
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.
980 studies on the registry are indexed under Congenital Abnormalities; 177 are open to participants now.
This study's planned enrollment of 62 is above the median of 49 across 491 interventional studies indexed under Congenital Abnormalities.
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Exclusion Criteria:
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
Patients allocated to the control group will receive institutional standard vaginal care.
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.
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: 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)
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: One year 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: One year 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).
Time frame: 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).
Time frame: 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).
Time frame: One year post radiotherapy
Cancer relapse or recurrence
The posibility of cancer relapse or recurrence will be evaluated using the patients' medical records.
Time frame: One year post radiotherapy
Cancer relapse or recurrence
The posibility of cancer relapse or recurrence will be evaluated using the patients' medical records.
Time frame: Two years post radiotherapy
Cancer relapse or recurrence
The posibility of cancer relapse or recurrence will be evaluated using the patients' medical records.
Time frame: Three years post radiotherapy
Cancer relapse or recurrence
The posibility of cancer relapse or recurrence will be evaluated using the patients' medical records.
Time frame: Four years post radiotherapy
Cancer relapse or recurrence
The posibility of cancer relapse or recurrence will be evaluated using the patients' medical records.
Time frame: 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.
Time frame: Final radiotherapy session
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