Vaginal Oestriol to prevent vaginal stenosis (VESPA).
A phase II pilot study of the use of vaginal oestriol to prevent vaginal stenosis in patients treated with radiotherapy for gynaecological, rectal and anal malignancies.
Western Sydney Local Health District
45 participants
May 28, 2014
Interventional
Conditions
Summary
The primary purpose of this study is to assess the feasibility, safety, and activity of vaginal oestriol in preventing vaginal stenosis in women receiving radiotherapy for gynecological, rectal and anal malignancies. Who is it for? You may be eligible for this study if you are a woman aged 18 years or above, who has received external beam radiotherapy, with curative intent to the pelvis, for treatment of a confirmed diagnosis of gynaecological, rectal or anal cancer. Study details Participants will be asked to regularly apply vaginal oestriol cream following completion of pelvic radiotherapy, and will be followed up for safety and effectiveness. It is hoped that information from this study will help improve health-related quality of life for women after cancer treatment for gynecological, rectal and anal malignancies.
Eligibility
Inclusion Criteria6
- confirmed diagnosis of gynaecological, rectal or anal cancer
- received external beam radiotherapy, with curative intent to the pelvis, (both primary treatment and neo/adjuvant treatment) of at least 45 gray in 25 fractions, or equivalent
- aged 18 years or older
- able to read and write English, and give written, informed consent
- able to complete quality of life instruments
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Exclusion Criteria4
- severe psychiatric, cognitive or physical disorder that would preclude them from inserting an applicator
- receiving radiotherapy for recurrent disease
- had estrogen receptor positive breast cancer within last 5 years
- currently on hormone replacement therapy (HRT).Those patients who were previously on hormone replacement therapy can go into the study as long as they have ceased the HRT at least 4 weeks prior to entry into the study
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Interventions
Application of vaginal oestriol topical cream to prevent vaginal stenosis in women receiving radiotherapy for gynecological, rectal and anal malignancies. Patient will commence the study drug 2 weeks post completion of pelvic radiotherapy treatment along with instructions for use and/or demonstration of oestriol applicator use by the clinician or clinic nurse. Participants will be instructed to insert the applicator with a dose of 0.5 mg of the study drug Oestriol 0.1% (1mg per g topical cream) to the top of the vagina daily for the first two weeks and then twice weekly for the rest of the intervention period (12 months application of oestriol). Information about compliance with the intervention will be collected at scheduled visits (1, 3, 6,9, 12 month after start of oestriol) using the Adherence and Disruption Questionnaire.
Locations(6)
View Full Details on ANZCTR
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ACTRN12621001366842