Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06305494 |
| Other study ID # |
HE671008 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 14, 2024 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Khon Kaen University |
| Contact |
Apiwat Jongjakapun, MD |
| Phone |
+66642546560 |
| Email |
apiwjo[@]kku.ac.th |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
