Study of Vaginal Dilator Use After Pelvic Radiotherapy

Completed

• Conditions: Endometrial Cancer; Anal Cancer; Rectal Cancer; Cervical Cancer
• Interventions: Device: Vaginal Dilator

• Registration Number: NCT00789893
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-12
• Study First Submitted QC: 2008-11-12
• Study First Posted: 2008-11-13
• Status Verified: 2015-06
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Last Update Submitted: 2015-06-10
• Last Update Posted: 2015-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 115

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

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women with cervical, endometrial, rectal or anal cancer	Vaginal Dilator	Women seen in the radiation oncology clinic with cervical, endometrial, rectal or anal cancer who will receive external beam pelvic radiation or brachytherapy

Primary Outcome Measures

Name	Time	Method
To measure compliance with vaginal dilator use.	conclusion of study
To examine the effect of dilator use in minimizing vaginal stenosis so that patients are able to use the pre-radiation baseline dilator size 6 months after starting dilator use.	conclusion of study

Secondary Outcome Measures

Name	Time	Method
To measure vaginal symptoms related to vaginal stenosis during vaginal dilation over 6 months after starting dilator use.	conclusion of study
To explore reasons for non-compliance with use of dilators.	conclusion of study
To explore patient-reported self-efficacy as it relates to the use of the vaginal dilator.	conclusion of study

Trial Locations

Locations (5)

Memorial Sloan Kettering at Basking Ridge; 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Cancer Center @ Suffolk; 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering at Mercy Medical Center; 🇺🇸 Rockville Centre, New York, United States

Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital; 🇺🇸 Sleepy Hollow, New York, United States