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NCT Number: NCT05165056

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ziekenhuis Oost-Limburg, Genk, Limburg, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intimleds

Device

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.

Primary outcomes

  1. CTCAE-score

    Time frame: Baseline

    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)

  2. CTCAE-score

    Time frame: Two weeks 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)

  3. CTCAE-score

    Time frame: 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)

  4. RIVT symptoms

    Time frame: Baseline

    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).

  5. RIVT symptoms

    Time frame: Final radiotherapy session

    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).

  6. RIVT symptoms

    Time frame: Two weeks 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).

  7. RIVT symptoms

    Time frame: Three months 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).

  8. RIVT symptoms

    Time frame: 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 outcomes

  1. Vaginal health index (VHI)

    Time frame: Baseline

    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

  2. Vaginal health index (VHI)

    Time frame: Two weeks 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

  3. Vaginal health index (VHI)

    Time frame: 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

  4. Pain score

    Time frame: Baseline

    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.

  5. Pain score

    Time frame: Two weeks 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.

  6. Pain score

    Time frame: Three months 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.

  7. Pain score

    Time frame: 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.

  8. Quality of Life score

    Time frame: Baseline

    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).

  9. Quality of Life score

    Time frame: Two weeks 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.

  10. Quality of Life score

    Time frame: Three months 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.

  11. Quality of Life score

    Time frame: 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.

  12. Sexual functioning score

    Time frame: Baseline

    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).

  13. Sexual functioning score

    Time frame: Two weeks 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).

  14. Sexual functioning score

    Time frame: Three months 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).

  15. Sexual functioning score

    Time frame: 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).

  16. Sexual distress score

    Time frame: Baseline

    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.

  17. Sexual distress score

    Time frame: Two weeks 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.

  18. Sexual distress score

    Time frame: Three months 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.

  19. Sexual distress score

    Time frame: 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.

  20. Satisfaction score

    Time frame: Two weeks 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).

  21. Satisfaction score

    Time frame: Three months 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).

  22. Satisfaction score

    Time frame: 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).

Other outcomes

  1. General patient-, disease-, and treatment-related information

    Time frame: Baseline

    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).

  2. General patient-, disease-, and treatment-related information

    Time frame: Three months post radiotherapy

    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).

  3. General patient-, disease-, and treatment-related information

    Time frame: One year post radiotherapy

    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).

  4. Cancer relapse or recurrence

    Time frame: One year post radiotherapy

    The posibility of cancer relapse or recurrence will be evaluated using the patients' medical records.

  5. Cancer relapse or recurrence

    Time frame: Two years post radiotherapy

    The posibility of cancer relapse or recurrence will be evaluated using the patients' medical records.

  6. Cancer relapse or recurrence

    Time frame: Three years post radiotherapy

    The posibility of cancer relapse or recurrence will be evaluated using the patients' medical records.

  7. Cancer relapse or recurrence

    Time frame: Four years post radiotherapy

    The posibility of cancer relapse or recurrence will be evaluated using the patients' medical records.

  8. Cancer relapse or recurrence

    Time frame: Five years post radiotherapy

    The posibility of cancer relapse or recurrence will be evaluated using the patients' medical records.

  9. Radiotherapy dose

    Time frame: Final radiotherapy session

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jeroen Mebis, Prof. Dr.

CONTACT

[email protected]

+32 11 33 72 21

Marithé Claes, MSc

CONTACT

[email protected]

+32 11 33 72 39

Sponsors and collaborators

Lead sponsor

Jessa Hospital

Other

Collaborators

  • Hasselt University
  • Ziekenhuis Oost-Limburg

Registry information

Official study title

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

Acronym: GynLight

Important dates

Study start
2022
Primary completion
2030
Study completion
2030
First posted
Dec 21, 2021
Registry last updated
Sep 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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