NCT Number: NCT00053261
Vaginal Changes and Sexual Function in Patients With Cervical Cancer
RATIONALE: Vaginal changes that may effect sexual function occur in patients undergoing treatment for cervical cancer.
PURPOSE: Clinical trial to determine the type of vaginal changes such as vaginal dryness that occur in patients receiving treatment for cervical cancer and the effect these changes have on sexual function.
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Notify MeKey information
Conditions
Age range
Up to 69 year
Sex eligibility
Female
Study type
Observational
Primary location
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah, Georgia, United States
About this study
OBJECTIVES:
- Obtain estimates of changes in vaginal length, perceived vaginal elasticity, perceived vaginal lubrication, and sexual activity, response, and satisfaction among patients with stage IB2 cervical cancer.
- Compare these differences between the patients in the two treatment groups in GOG-0201.
- Determine the relationships between vaginal dilation activities and vaginal length changes in these patients.
- Determine the association between smoking and vaginal length and between smoking and vaginal dryness in these patients after therapy for cervical cancer.
- Assess the extent of subject interest in and preferred methods of sexual counseling related to problems resulting from treatment in these patients.
OUTLINE: Vaginal length is measured using Vaginal Sound, a modified plastic vaginal dilator. The data about vaginal elasticity and lubrication and sexual activity, response, and satisfaction are obtained from patient self-report, as well as vaginal dilation activities. Measurement and assessments are taken before treatment and then at 3, 6, 12, and 24 months.
Patients are followed every 3 months for 2 years.
PROJECTED ACCRUAL: Approximately 150 patients will be accrued for this study.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
DISEASE CHARACTERISTICS:
- Entered and treated on GOG-0201 or eligible for and treated on either arm of GOG-0201
- May have refused entry on GOG-0201 as long as treatment is prescribed according to one or the other arm
PATIENT CHARACTERISTICS:
Age
- Under 70
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Treatment and study plan
Sponsors and collaborators
Lead sponsor
Gynecologic Oncology Group
Network
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
Vaginal Length, Elasticity, Lubrication And Sexual Function In Women With Stage IB2 Cervix Carcinoma
Important dates
- Study start
- 2003
- Primary completion
- 2007
- First posted
- Jan 28, 2003
- Registry last updated
- May 27, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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