Study of Vaginal Dilator Use After Pelvic Radiotherapy

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Endometrial Cancer; Anal Cancer; Cervical Cancer; Rectal Cancer

Treatments: Device: Vaginal Dilator

Study type: Observational

Funder types: Other

Identifiers

NCT00789893

08-127

Details and patient eligibility

About

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.

Enrollment: 115 patients

Sex: Female

Ages: 21 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

115 participants in 1 patient group

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

Treatment:

Device: Vaginal Dilator