Clinical Trial NCI UP10G01
- Randomized Feasibility Study of Dilator Use and an Educational Program to Increase Compliance after Vaginal Brachytherapy for Endometrial Cancer
- Principal Investigator
- Eric Donnelly
- Status: Accepting New Patients
- Study Type: Supportive Care, Symptom Management
- Protocol No:.NCI UP10G01
- The purpose of this study is to see if the use of a vaginal dilator, a device provided by the study doctor or nurse, will help keep the vagina a normal length after vaginal brachytherapy (VBT) for the treatment of endometrial cancer.
- This study is for women who has been treated for endometrial cancer and have planned for a post-operative procedure called vaginal brachytherapy (VBT). VBT can cause shortening of the vagina that may interfere with normal sexual functioning. Use of a vaginal dilator may be effective in lengthening the vagina resulting in better sexual function. In this study we are will be looking at how often women use the vaginal dilator and if using the vaginal dilator helps maintain sexual function at the level it was before treatment with VBT. The use of a vaginal dilator is standard care after VBT.
Some of the eligibility criteria include:
- Participants must be females, 18 years of age or older.
- Participants must have stage I-IIIc endometroid endometrial cancer and have undergone a hysterectomy and oophorectomy (removal of the ovaries) +/- lymphadenectomy (remove of surrounding lymph nodes).
- Participants must have a planned post-operative vaginal brachytherapy and have no prior history of pelvic radiotherapy or chemotherapy.
- Description of Treatment
- Study participants will be randomized to one of two treatment groups. Participants in both groups will use the vaginal dilator. One of the groups will also spend time with a study nurse who will provide enhanced education about the device. From the beginning of the study and for the duration (6 months) all participants will be given instructions on when and how to use the vaginal dilator. Participants will be asked to continue dilator use for the entire 6 months and to keep a calendar tracking dilator use and any sexual activity. The calendars will be collected at 6 weeks and 6 months after beginning the study. During office visits questionnaires will be completed by participants and vaginal length will be measured by the doctor using The Vaginal Sound device. This device was designed and created by the study Principal Investigator and it has been used and tested in previous research. The measurement will take less than one minute and is less invasive and less uncomfortable than a routine speculum exam. The Vaginal Sound is covered with a lubricated, non-latex condom for ease of insertion and cleanliness.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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last updated: 22-Dec-14 03:10 AM
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