Clinical Trial: Vaginal Changes and Sexual Function in Patients With Cervical Cancer

This study is currently recruiting patients.

Sponsors and Collaborators: Gynecologic Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

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.

Condition Treatment or Intervention
sexuality and reproductive issues
stage IB cervical cancer
 Procedure: complications of therapy assessment/management
 Procedure: supportive care/therapy

MedlinePlus related topics:  Cervical Cancer

Study Type: Interventional
Study Design: Treatment

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

Further Study Details: 

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.

Eligibility

Ages Eligible for Study:  up to  69 Years,  Genders Eligible for Study:  Both

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

Location and Contact Information


Arizona
      CCOP - Western Regional, Arizona, Phoenix,  Arizona,  85006-2726,  United States; Recruiting
David Kyle King, MD, FACP  602-239-2413    david.king@baannerhealth.com 

Delaware
      CCOP - Christiana Care Health Services, Newark,  Delaware,  19713,  United States; Recruiting
Stephen Scott Grubbs, MD  302-623-4100 

Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States; Recruiting
Kendrith M. Rowland, MD  217-383-4083    kendrith.rowland@carle.com 

      CCOP - Central Illinois, Decatur,  Illinois,  62794-9640,  United States; Recruiting
L. Stewart Massad, MD  217-545-8882 

      CCOP - Evanston, Evanston,  Illinois,  60201,  United States; Recruiting
Gershon Y. Locker, MD, FACP  847-570-2518    glocker@enh.org 

      MBCCOP - University of Illinois at Chicago, Chicago,  Illinois,  60612,  United States; Recruiting
Lawrence Eric Feldman, MD  312-335-3614 

Indiana
      Saint Joseph Regional Medical Center, South Bend,  Indiana,  46617,  United States; Recruiting
Michael W. Method, MD, MPH  574-237-8010    mmethod@mhopc.com 

Michigan
      CCOP - Grand Rapids, Grand Rapids,  Michigan,  49503,  United States; Recruiting
Kathleen Jo Yost, MD  616-391-1230 

      CCOP - Kalamazoo, Kalamazoo,  Michigan,  49007-3731,  United States; Recruiting
Raymond Sterling Lord, MD  269-373-7488    rlord@wmcc.org 

      CCOP - Michigan Cancer Research Consortium, Ann Arbor,  Michigan,  48106,  United States; Recruiting
Philip J. Stella, MD  734-712-5237    beekmanl@trinity-health.org 

Minnesota
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States; Recruiting
Patrick J. Flynn, MD  952-993-1517    patrick.flynn@usoncology.com 

Missouri
      CCOP - Cancer Research for the Ozarks, Springfield,  Missouri,  65807,  United States; Recruiting
John Wendall Goodwin, MD  417-269-4520    jwg684@sprg.mercy.net 

      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States; Recruiting
William T. Stephenson, MD  816-823-0555 

      Siteman Cancer Center at Barnes-Jewish Hospital, Saint Louis,  Missouri,  63110,  United States; Recruiting
David Gardner Mutch, MD  314-362-3181 

Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68106,  United States; Recruiting
James A. Mailliard, MD  402-280-4364    jamailliard@mrcc.cc 

North Carolina
      Gynecologic Oncology Network, Greenville,  North Carolina,  27858,  United States; Recruiting
Howard David Homesley, MD  252-756-5388    hdh7173@aol.com 

      Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill,  North Carolina,  27599-7570,  United States; Recruiting
Wesley C. Fowler, MD  919-966-1196    wfowler@med.unc.edu 

Ohio
      Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus,  Ohio,  43210-1240,  United States; Recruiting
Jeffrey McCabe Fowler, MD  614-293-8737 

      Charles M. Barrett Cancer Center at University Hospital, Cincinnati,  Ohio,  45267-0520,  United States; Recruiting
Nader Husseinzadeh, MD  513-558-8450    nallerhusseinzadeh@uc.edu 

Oregon
      CCOP - Columbia River Oncology Program, Portland,  Oregon,  97225,  United States; Recruiting
Keith S. Lanier, MD  503-216-6260 

Pennsylvania
      Abington Memorial Hospital, Abington,  Pennsylvania,  19001-3788,  United States; Recruiting
Parviz Hanjani, MD  215-885-0220    phanjani@amh.org 

      CCOP - Geisinger Clinic and Medical Center, Danville,  Pennsylvania,  17822-2001,  United States; Recruiting
Nava Siegelmann-Danieli, MD  570-271-6834    nsdanieli@geisinger.edu 

      UPMC Cancer Center at Magee-Womens Hospital, Pittsburgh,  Pennsylvania,  15213-3180,  United States; Recruiting
Joseph L. Kelley, MD  412-641-5418    jkelley@mail.magee.edu 

Tennessee
      Southeast Gynecologic Oncology Associates, Knoxville,  Tennessee,  37917,  United States; Recruiting
Kenneth F. Cofer, MD  865-673-9250 

      Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville,  Tennessee,  37232-2516,  United States; Recruiting
Marta Ann Crispens, MD  615-322-2114    marta.crispens@vanderbilt.edu 

Texas
      CCOP - Scott and White Hospital, Temple,  Texas,  76508,  United States; Recruiting
Lucas Wong, MD  254-724-1053    lwong@swmail.sw.org 

Wisconsin
      CCOP - Marshfield Clinic Research Foundation, Marshfield,  Wisconsin,  54449,  United States; Recruiting
Anthony Evans, MD, PhD  715-387-5161    evans.anthony@marshfieldclinic.org 

Study chairs or principal investigators

Deborah Watkins Bruner, RN, PhD,  Study Chair,  Fox Chase Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000269327; GOG-8003; NCT00053261
Record last reviewed:  December 2004
Last Updated:  April 4, 2005
Record first received:  January 27, 2003
ClinicalTrials.gov Identifier:  NCT00053261
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005