Study of Vaginal Dilator Use After Pelvic Radiotherapy

Cervical Cancer Clinical Trial

Official title:

A Descriptive Study of Vaginal Dilator Use After Pelvic Radiotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00789893
• Other study ID #: 08-127
• Status: Completed
• Phase: N/A
• First received: November 12, 2008
• Last updated: June 10, 2015
• Start date: November 2008
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 85 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anal Cancer
• Cervical Cancer
• Endometrial Cancer
• Rectal Cancer
• Uterine Cervical Neoplasms

Intervention

Device:
• Vaginal Dilator
Participants will be instructed to use the dilators 3 times per week, regardless of frequency of sexual intercourse. At 5 time points, data will be collected to determine vaginal dilator size, grade vaginal stenosis & assess vaginal symptoms. 1)Baseline: patient self-assessment following consultation up until the end of the first week of radiation 2)Post-radiation: patient self-assessment one month ± 2 weeks follow-up from last day of radiation 3)Post-radiation: 3 month ± 4 weeks follow-up from initiation of dilator use 4)Post-radiation: 6 month ± 4 weeks follow-up from initiation of dilator use 5)Post-radiation: 12 months ± 4 weeks follow-up from initiation of dilator use. At the 1st & 2nd time points, the nurse will telephone the patient to retrieve her responses. The 1st phone call will occur between the time following consultation up until the end of the first week of radiation, & the 2nd will be one month ± 2 weeks from last day of radiation.

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To measure compliance with vaginal dilator use.		conclusion of study	No
Primary	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	No
Secondary	To measure vaginal symptoms related to vaginal stenosis during vaginal dilation over 6 months after starting dilator use.		conclusion of study	No
Secondary	To explore reasons for non-compliance with use of dilators.		conclusion of study	No
Secondary	To explore patient-reported self-efficacy as it relates to the use of the vaginal dilator.		conclusion of study	No

External Links

•   Memorial Sloan Kettering Cancer Center