Clinical trial NCT03714581: Laser Therapy Following Radiotherapy for Gynecological Cancer
Official title: The Efficacy of Intravaginal Laser Therapy in Women With History of Gynecological Cancer Treated With Pelvic Radiotherapy: Double-blind Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Radiotherapy
Gynecological Cancer
Dyspareunia
Vaginal Dryness
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2018-10-22
Enrollment: 112
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Women with a history of pelvic radiotherapy due to gynecological cancer, will receive laser therapy for the management of genitourinary syndrome of menopause.


Eligibility criteria: Inclusion Criteria:

* History of gynecological cancer treated with pelvic radiotherapy
* last radiotherapy \>1 year
* women sexually active or willing to resume sexual activity
* symptoms of dyspareunia, vaginal dryness, itching/burning and vaginal bleeding related to sexual intercourse

Exclusion Criteria:

* Relapse of gynecological cancer
* prolapse stage \>1
* active genital infection (i.e herpes, vaginitis)
* underlying pathologies that could interfere with patients compliance to the protocol (i.e any psychiatric condition)

Primary outcomes:
measure: 10-centimeter Visual Analogue Scale assessing intensity of dyspareunia and dryness
timeFrame: Change from baseline at 1 month post-treatment
Secondary outcomes:
measure: 3 days voiding diary
timeFrame: Change from baseline at 1 month post-treatment
measure: Day-to Day Impact of vaginal aging questionnaire (DIVA)
timeFrame: Change from baseline at 1 month post-treatment
measure: The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire (QLQ) cervical cancer module (CX24)
timeFrame: Change from baseline Quality of Life questionnaire (QLQ) cervical cancer module (CX24) at 1-month post-treatment
measure: Patients Global Impression of Improvement
timeFrame: At 1-month post-treatment
measure: International Consultation on Incontinence Questionnaire Short Form/Female Lower Urinary tract Symptoms (ICIQ-FLUTS)
timeFrame: Change from baseline International Consultation on Incontinence Questionnaire Short Form/Female Lower Urinary tract Symptoms (ICIQ-FLUTS) at 1-month post-treatment
measure: King's Health Questionnaire (KHQ)
timeFrame: Change from baseline King's Health Questionnaire at 1-month post-treatment
measure: Female Sexual Function Index
timeFrame: Change from baseline Female Sexual Function Index at 1-month post-treatment
measure: Vaginal Maturation Value
timeFrame: Change from baseline Vaginal Maturation Value at 1-month post-treatment
measure: Vaginal Health Index Score
timeFrame: Change from baseline Vaginal Health Index Score at 1-month post-treatment
measure: Partner Performance Questionnaire
timeFrame: Change from baseline Partner Performance Questionnaire at 1-month post-treatment
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Urogynecological Unit of Alexandra Hospital
Study officials:
affiliation: National and Kapodistrian University of Athens, Greece
name: Stavros Athanasiou, Associate Proffesor
role: STUDY_DIRECTOR
References:
citation: Athanasiou S, Pitsouni E, Grigoriadis T, Michailidis G, Tsiveleka A, Rodolakis A, Loutradis D. A study protocol of vaginal laser therapy in gynecological cancer survivors. Climacteric. 2020 Feb;23(1):53-58. doi: 10.1080/13697137.2019.1646720. Epub 2019 Sep 2.