Vaginal Oestriol to prevent vaginal stenosis (VESPA).

ABSTRACT: 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. Primary outcome(s): Feasibility, compliance and acceptability of the use of vaginal oestriol, as measured by adherence and disruption questionnaire (ADQ). This will be assessed as a composite outcome.[12 months post end of radiotherapy];The incidence of stenosis as measured by the LENT-SOMA scale on the basis of clinical assessment.[12 months post end of radiotherapy ];Safety - measured using the serum levels of oestradiol and FSH in blood tests taken at regular intervals.[Assessed at every treatment appointment up to 12 months post end of radiotherapy] Study Design: Purpose: Prevention; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy

DISEASE(S): Cancer-womb (uterine Or Endometrial Cancer),Vaginal Stenosis Following Radiotherapy,Cancer-bowel-anal,Cancer-cervical (cervix),Cancer-bowel-back Passage (rectum) Or Large Bowel (colon)

PROVIDER: 2472959 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR