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Recruiting NCT05165056

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

No phase Interventional Radiotherapy Side Effect Vaginal Abnormality

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intimleds.
Who it may be relevant to
Registry conditions: Radiotherapy Side Effect, Vaginal Abnormality. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • CTCAE-score [Time frame: Baseline]
  • CTCAE-score [Time frame: Two weeks post radiotherapy]
  • CTCAE-score [Time frame: Three months post radiotherapy]
  • RIVT symptoms [Time frame: Baseline]
  • RIVT symptoms [Time frame: Final radiotherapy session]
  • RIVT symptoms [Time frame: Two weeks post radiotherapy]
  • RIVT symptoms [Time frame: Three months post radiotherapy]
  • RIVT symptoms [Time frame: One year post radiotherapy]
Secondary outcome measures (12)
  • Vaginal health index (VHI) [Time frame: Baseline]
  • Vaginal health index (VHI) [Time frame: Two weeks post radiotherapy]
  • Vaginal health index (VHI) [Time frame: Three months post radiotherapy]
  • Pain score [Time frame: Baseline]
  • Pain score [Time frame: Two weeks post radiotherapy]
  • Pain score [Time frame: Three months post radiotherapy]
  • Pain score [Time frame: One year post radiotherapy]
  • Quality of Life score [Time frame: Baseline]
  • Quality of Life score [Time frame: Two weeks post radiotherapy]
  • Quality of Life score [Time frame: Three months post radiotherapy]
  • Quality of Life score [Time frame: One year post radiotherapy]
  • Sexual functioning score [Time frame: Baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Belgium · 2 centers
  • Ziekenhuis Oost-Limburg — Genk
  • Jessa Hospital — Hasselt

Identifiers

NCT: NCT05165056 · 2021/099

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗