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Vaginal Changes and Sexual Function in Patients With Cervical Cancer

Vaginal Length, Elasticity, Lubrication And Sexual Function In Women With Stage IB2 Cervix Carcinoma

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00053261
Enrollment
Unknown
Registered
2003-01-28
Start date
2003-07-31
Completion date
Unknown
Last updated
2013-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer, Sexuality and Reproductive Issues

Keywords

sexuality and reproductive issues, stage IB cervical cancer

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREmanagement of therapy complications

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Gynecologic Oncology Group
Lead SponsorNETWORK

Eligibility

Sex/Gender
FEMALE
Age
No minimum to 69 Years
Healthy volunteers
No

Inclusion criteria

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026