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

Jessa Hospital

Status: Enrolling

Conditions: Radiotherapy Side Effect; Vaginal Abnormality

Treatments: Device: Intimleds

Study type: Interventional

Funder types: Other

Identifiers

NCT05165056

2021/099

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

62 participants in 2 patient groups

Treatment group

Experimental group

Description:

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.

Treatment:

Device: Intimleds

Control group

No Intervention group

Description:

Patients allocated to the control group will receive institutional standard vaginal care.