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NCT00053261 Clinical Trial

Vaginal Changes and Sexual Function in Patients With Cervical Cancer

Cervical Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00053261
Other study ID # CDR0000269327
Secondary ID GOG-8003
Status Completed
Phase N/A
First received January 27, 2003
Last updated May 24, 2013
Start date July 2003

Study information
Verified date June 2005
Source Gynecologic Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date January 2007
Accepts healthy volunteers No
Gender Female
Age group N/A to 69 Years
Eligibility 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

Study Design

N/A

Related Conditions & MeSH terms

Intervention

Procedure:
• management of therapy complications

Locations
Country Name City State
United States Abington Memorial Hospital Abington Pennsylvania
United States John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital Allentown Pennsylvania
United States Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill North Carolina
United States Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia Missouri
United States Bronson Methodist Hospital Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States Borgess Medical Center Kalamazooaa Michigan
United States Oklahoma University Medical Center Oklahoma City Oklahoma
United States Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah Georgia
United States Long Island Cancer Center at Stony Brook University Hospital Stony Brook New York
United States SUNY Upstate Medical University Hospital Syracuse New York
United States Cancer Care Associates - Midtown Tulsa Tulsa Oklahoma

Sponsors (2)
Lead Sponsor Collaborator
Gynecologic Oncology Group National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

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