RecruitingPhase 2ACTRN12621001366842

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.


Sponsor

Western Sydney Local Health District

Enrollment

45 participants

Start Date

May 28, 2014

Study Type

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

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Radiotherapy to the pelvic region — used to treat gynaecological, rectal, or anal cancers — can cause the vaginal tissues to become scarred and narrow over time, a condition called vaginal stenosis. This can cause pain, make pelvic examinations difficult, and significantly affect quality of life and intimate relationships. This study is testing whether regularly applying a vaginal oestriol cream (a mild, low-dose form of oestrogen) after completing radiotherapy can prevent or reduce this scarring. The cream is applied at home, making it convenient and non-invasive. Participants are followed over time to assess both safety and how well the treatment works. You may be eligible if you are a woman aged 18 or older who has received pelvic radiotherapy with curative intent for a gynaecological, rectal, or anal cancer. You should be able to use an applicator to apply the cream. Women currently on hormone replacement therapy, or those who have had oestrogen receptor-positive breast cancer in the past five years, are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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)

Westmead Hospital - Westmead

NSW,QLD, Australia

Calvary Mater Newcastle - Waratah

NSW,QLD, Australia

Princess Alexandra Hospital - Woolloongabba

NSW,QLD, Australia

Gold Coast University Hospital - Southport

NSW,QLD, Australia

Royal Brisbane & Womens Hospital - Herston

NSW,QLD, Australia

Prince of Wales Private Hospital - Randwick

NSW,QLD, Australia

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ACTRN12621001366842