Clinical trial NCT05165056: Photobiomodulation Therapy in the Prevention and Management of Radiotherapy-induced Vaginal Toxicity
Official title: Evaluating the Feasibility and Efficacy of Photobiomodulation Therapy in the Prevention and Management of Radiotherapy-induced Vaginal Toxicity: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Radiotherapy Side Effect
Vaginal Abnormality
Keywords: Photobiomodulation therapy
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
Collaborators: name: Ziekenhuis Oost-Limburg
name: Hasselt University
First posted: 2021-12-21
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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

Primary outcomes:
measure: CTCAE-score
timeFrame: Baseline
measure: CTCAE-score
timeFrame: Two weeks post radiotherapy
measure: CTCAE-score
timeFrame: Three months post radiotherapy
measure: RIVT symptoms
timeFrame: Baseline
measure: RIVT symptoms
timeFrame: Final radiotherapy session
measure: RIVT symptoms
timeFrame: Two weeks post radiotherapy
measure: RIVT symptoms
timeFrame: Three months post radiotherapy
measure: RIVT symptoms
timeFrame: One year post radiotherapy
Secondary outcomes:
measure: Vaginal health index (VHI)
timeFrame: Baseline
measure: Vaginal health index (VHI)
timeFrame: Two weeks post radiotherapy
measure: Vaginal health index (VHI)
timeFrame: Three months post radiotherapy
measure: Pain score
timeFrame: Baseline
measure: Pain score
timeFrame: Two weeks post radiotherapy
measure: Pain score
timeFrame: Three months post radiotherapy
measure: Pain score
timeFrame: One year post radiotherapy
measure: Quality of Life score
timeFrame: Baseline
measure: Quality of Life score
timeFrame: Two weeks post radiotherapy
measure: Quality of Life score
timeFrame: Three months post radiotherapy
measure: Quality of Life score
timeFrame: One year post radiotherapy
measure: Sexual functioning score
timeFrame: Baseline
measure: Sexual functioning score
timeFrame: Two weeks post radiotherapy
measure: Sexual functioning score
timeFrame: Three months post radiotherapy
measure: Sexual functioning score
timeFrame: One year post radiotherapy
measure: Sexual distress score
timeFrame: Baseline
measure: Sexual distress score
timeFrame: Two weeks post radiotherapy
measure: Sexual distress score
timeFrame: Three months post radiotherapy
measure: Sexual distress score
timeFrame: One year post radiotherapy
measure: Satisfaction score
timeFrame: Two weeks post radiotherapy
measure: Satisfaction score
timeFrame: Three months post radiotherapy
measure: Satisfaction score
timeFrame: One year post radiotherapy
Other outcomes:
measure: General patient-, disease-, and treatment-related information
timeFrame: Baseline
measure: General patient-, disease-, and treatment-related information
timeFrame: Three months post radiotherapy
measure: General patient-, disease-, and treatment-related information
timeFrame: One year post radiotherapy
measure: Cancer relapse or recurrence
timeFrame: One year post radiotherapy
measure: Cancer relapse or recurrence
timeFrame: Two years post radiotherapy
measure: Cancer relapse or recurrence
timeFrame: Three years post radiotherapy
measure: Cancer relapse or recurrence
timeFrame: Four years post radiotherapy
measure: Cancer relapse or recurrence
timeFrame: Five years post radiotherapy
measure: Radiotherapy dose
timeFrame: Final radiotherapy session
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
city: Hasselt
country: Belgium
facility: Jessa Hospital
state: Limburg
Study officials:
affiliation: Jessa Hospital
name: Jeroen Mebis, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: