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NCT Number: NCT00789893

Study of Vaginal Dilator Use After Pelvic Radiotherapy

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.

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Key information

Conditions

Cervical Cancer Anal Cancer Anus Diseases Anus Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Cancer Rectal Diseases Rectal Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

21 year–85 year

Sex eligibility

Female

Study type

Observational

Primary location

Memorial Sloan Kettering at Basking Ridge, Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vaginal Dilator

Device

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.

Other names: The remaining assessments will be performed during the patient's regularly, scheduled follow-up appointments or via phone calls.

Primary outcomes

  1. To measure compliance with vaginal dilator use.

    Time frame: conclusion of study

  2. 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.

    Time frame: conclusion of study

Secondary outcomes

  1. To measure vaginal symptoms related to vaginal stenosis during vaginal dilation over 6 months after starting dilator use.

    Time frame: conclusion of study

  2. To explore reasons for non-compliance with use of dilators.

    Time frame: conclusion of study

  3. To explore patient-reported self-efficacy as it relates to the use of the vaginal dilator.

    Time frame: conclusion of study

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

A Descriptive Study of Vaginal Dilator Use After Pelvic Radiotherapy

Important dates

Study start
2008
Primary completion
2015
Study completion
2015
First posted
Nov 13, 2008
Registry last updated
Jun 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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