Clinical trial NCT06305494: Genitourinary Syndrome of Menopause in Thai Gynecologic Cancer Survivors
Official title: Genitourinary Syndrome of Menopause in Thai Gynecologic Cancer Survivors: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrophic Vaginitis
Gynecologic Cancer
Lower Urinary Tract Symptoms
Keywords: Genitourinary syndrome of menopause
Gynecologic cancer
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 425
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Gynecologic cancer survivors, age more than 18 years old that came to the Gynecology Clinic at Khon Kaen University Hospital for routine cancer surveillance.

Brief summary: Women often face common cancers like ovarian, uterine, and cervical cancers. Improvements in cancer detection and treatment mean more women survive. However, survivors can encounter challenges like ongoing pain, treatment complications, and fertility issues.

Treating these cancers often involves surgeries that might include removing ovaries or using pelvic radiation. This can trigger menopause in younger women, causing problems like vaginal dryness, itching, and urinary issues.

Women who've gone through menopause often deal with these symptoms, affecting their daily lives, confidence, and intimate relationships. Though treatments are available, lack of awareness, embarrassment, and not discussing these issues with doctors can make managing them difficult.

The main treatment for these symptoms is using vaginal estrogen, but it might not be suitable for some cancer survivors. Non-hormonal options like lubricants and moisturizers are alternatives. This study in Thailand aiming to explore how common these issues are among gynecological cancer survivors, their feelings about it, and how it affects their quality of life.

Detailed description: Gynecological cancers, encompassing ovarian, endometrial, and cervical cancers, stand as significant health concerns for women. In 2017, a total of 12,354 new cases were diagnosed in Thailand, underlining the prevalence and impact of these conditions. Advances in cancer screening and treatment have notably improved outcomes, resulting in a growing number of survivors. By 2016, the United States alone recorded 15.5 million cancer survivors, with projections indicating a surge to 26.1 million by 2040. However, even with increased survival rates, challenges persist for survivors, encompassing chronic pain, complications from treatment, and disruptions to fertility, menopause, sexual function, and cognitive health.

The treatment landscape for gynecological cancers is diverse, with the general principle for ovarian and endometrial cancers involving surgical staging. This comprehensive approach includes the removal of the uterus, fallopian tubes, both ovaries, peritoneum, pelvic lymph nodes, and any visible lesions. For cervical cancer, treatment varies based on disease stage. Early-stage cases often undergo surgery, potentially followed by pelvic irradiation. In advanced-stage cervical cancer, a combination of pelvic radiation and chemotherapy is commonly employed. In summary, many gynecological cancer treatments involve the removal of both ovaries or pelvic irradiation, inducing menopause in reproductive-age women.

The female lower reproductive system, including the lower urinary tract, is intricately responsive to estrogenic stimulation. When estrogen is lacking, structural changes occur, giving rise to a cluster of symptoms collectively termed the genitourinary syndrome of menopause (GSM). Estrogen deficiency results in thinning of the vaginal epithelium lining, diminished collagen and elastin fibers, reduced blood supply, and moisture decline. These changes manifest as vaginal symptoms, including burning, itching, and pain during intercourse.

Similarly, the urinary tract, deprived of estrogenic stimulation, undergoes alterations such as urethral shortening, thinning of the urethral epithelium, weakened urethral sphincter contractions, and reduced elasticity of the urinary bladder. This cascade of changes results in lower urinary tract symptoms, comprising dysuria, urinary urgency, incontinence, frequency, nocturia, and recurrent urinary tract infections.

Postmenopausal women commonly experience these symptoms, and systematic literature reviews reveal a prevalence ranging from 13 to 87%. Furthermore, the chronic nature of these symptoms tends to intensify over time. Women who undergo early bilateral oophorectomy are more likely to enter menopause sooner, increasing the risk of developing various urogenital symptoms at a younger age.

The impact of these symptoms on women's lives is profound, affecting daily activities, self-confidence, and intimate relationships. Vaginal symptoms, in particular, can lead to sexual dysfunction, exacerbating challenges in family relationships. Concurrently, urinary symptoms contribute to decreased quality of life, with frequency, nocturia, and urgency correlating with the risk of falls and bone fractures. Additionally, these symptoms are associated with depressed mood, anxiety, and embarrassment, further disrupting aspects of life such as sleep, daily commute, social interactions, and sexual relationships.

Despite the significant impact on quality of life, the effective management of vaginal and genitourinary symptoms is impeded by various factors. These include a lack of knowledge and understanding of the diseases and available treatment options, feelings of embarrassment, and the notable observation that medical personnel often fail to inquire about these specific issues during patient consultations.

The primary treatment for genitourinary symptoms is typically the use of vaginal estrogen. However, certain gynecological cancers, such as leiomyosarcoma, endometrial stromal sarcoma, and specific ovarian cancers, preclude the use of estrogen therapy. In such cases, non-hormonal alternatives like vaginal lubricants, moisturizers, and energy-based devices come into consideration.

This study aim to explore the prevalence of GSM among gynecological cancer survivors. The investigation extends to understanding the magnitude of the problem, examining women's attitudes towards the condition, and assessing its broader impact on their quality of life. This comprehensive exploration seeks to contribute valuable insights to the understanding and management of the complex challenges faced by gynecological cancer survivors.

Eligibility criteria: Inclusion Criteria:

* Participant with gynecologic cancer (cancer of ovary, fallopian tube, uterus, cervix, vagina, and vulva.)
* Time passed more than 6 months since last cancer treatment.

Exclusion Criteria:

* Participant not entering menopause after cancer treatment.
* Participant with cancer progression.
* Participant currently suffer from severe pain, fatigue, or discomfort.
* Participant deny to participate.

Primary outcomes:
measure: Prevalence of genitourinary syndrome of menopause
timeFrame: Baseline
Secondary outcomes:
measure: Severity of genitourinary syndrome of menopause
timeFrame: Baseline
measure: Quality of life of gynecologic cancer survivor
timeFrame: Baseline
measure: Attitude toward genitourinary syndrome of menopause in gynecologic cancer survivor
timeFrame: Baseline
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Faculty of Medicine, Khon Kaen University
Study officials:
affiliation: Khon Kaen University
name: Apiwat Jongjakapun, MD
role: PRINCIPAL_INVESTIGATOR
References: