Study of Vaginal Dilator Use After Pelvic Radiotherapy

Completed

Conditions studied: Cervical Cancer, Endometrial Cancer, Rectal Cancer, Anal Cancer

In brief

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.

Key facts

Study ID

NCT00789893

Run by

Memorial Sloan Kettering Cancer Center

People needed

115

Starts

2008-11-01

Expected to finish

2015-06-01

Last updated by the study team

2015-06-11

Who can join

Age: 21 and older, up to 85. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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