Clinical Trials (PDQ®) - National Cancer Institute

Page Options

	Quick Links


	Director's Corner Dictionary of Cancer Terms NCI Drug Dictionary Funding Opportunities NCI Publications Advisory Boards and Groups Science Serving People Español

Questions about cancer?


	1-800-4-CANCER

	LiveHelp® online chat

	NCI Highlights


	High Dose Chemotherapy Prolongs Survival for Leukemia Prostate Cancer Study Shows No Benefit for Selenium, Vitamin E Past Highlights

Study of Vaginal Length, Elasticity, Lubrication, and Sexual Function in Patients With Stage IB2 Cervical Cancer

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Vaginal Changes and Sexual Function in Patients With Cervical Cancer

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

No phase specified

Natural history/Epidemiology

Completed

Under 70

NCI

GOG-8003
NCT00053261

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.

Entry 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

Prior/Concurrent Therapy:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Patient Characteristics:

Age

Under 70

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Expected Enrollment

Approximately 150 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Deborah Watkins Bruner, RN, PhD, Protocol chair
Ph: 215-728-2707; 888-369-2427

Related Information

PDQ® clinical trial GOG-0201

Registry Information

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

Trial Start Date		2003-07-21

Trial Completion Date		2007-01-14

Registered in ClinicalTrials.gov		NCT00053261

Date Submitted to PDQ		2002-11-20

Information Last Verified		2005-06-07

NCI Grant/Contract Number		CA27469

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.