Brief Title
Study of Vaginal Dilator Use After Pelvic Radiotherapy
Official Title
A Descriptive Study of Vaginal Dilator Use After Pelvic Radiotherapy
Brief Summary
Patient will have radiation to treat the cancer. This treatment can make the vagina both
narrower and shorter. That can cause two problems. It can make it harder for the doctor to do
a pelvic exam during a follow-up visits. And, it can make sexual intercourse uncomfortable.
We tell women to use a vaginal dilator after radiation to the pelvis. This is standard
education. We do not routinely ask women how they do with it. We are doing this study to see
if using the dilator as we instruct will help the vagina stretch. The patient will have an
examine of the vagina before the start of radiation. We will see what size dilator can fit.
The goal of this study is to have the patient be able to use that size dilator within six
months after radiation.
Study Type
Observational
Primary Outcome
To measure compliance with vaginal dilator use.
Secondary Outcome
To measure vaginal symptoms related to vaginal stenosis during vaginal dilation over 6 months after starting dilator use.
Condition
Cervical Cancer
Intervention
Vaginal Dilator
Study Arms / Comparison Groups
Women with cervical, endometrial, rectal or anal cancer
Description: Women seen in the radiation oncology clinic with cervical, endometrial, rectal or anal cancer who will receive external beam pelvic radiation or brachytherapy
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
115
Start Date
November 2008
Completion Date
June 2015
Primary Completion Date
June 2015
Eligibility Criteria
Inclusion Criteria:
- Female with cervical, endometrial, rectal or anal cancer
- Scheduled to begin one of the following treatments at MSKCC:
- Definitive external beam radiation therapy
- Preoperative external beam radiation therapy of followed by surgery
- Postoperative external beam radiation therapy
- Definitive external beam radiation therapy with intracavitary brachytherapy (tandem
and ring or Syed)± surgery
- Postoperative intravaginal brachytherapy (once every two weeks times three)
- ≥ or = to 21 years of age
Exclusion Criteria:
- Women with cervical, endometrial, rectal or anal cancer who are/have:
- Unable to speak and write English so that it would prohibit them from full
participation in the study. Patient education, instruction and questionnaire are
validated in English.
- Mental or physical handicaps that would prohibit them from full participation in the
study.
- Prior radiation to the pelvis.
- Evidence of metastatic disease.
Gender
Female
Ages
21 Years - 85 Years
Accepts Healthy Volunteers
No
Contacts
Ethel Law, MA, RN, OCN, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00789893
Organization ID
08-127
Responsible Party
Sponsor
Study Sponsor
Memorial Sloan Kettering Cancer Center
Study Sponsor
Ethel Law, MA, RN, OCN, Principal Investigator, Memorial Sloan Kettering Cancer Center
Verification Date
June 2015