Vaginal Oestriol to prevent vaginal stenosis (VESPA).

Phase 2

Recruiting

• Conditions: Vaginal stenosis following radiotherapy; Cancer - Cervical (cervix); Cancer - Womb (Uterine or endometrial cancer); Cancer - Bowel - Back passage (rectum) or large bowel (colon); Cancer - Bowel - Anal

• Registration Number: ACTRN12621001366842
• Lead Sponsor: Western Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-11
• Last Update Posted: 3 October 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 45

Inclusion Criteria

1. confirmed diagnosis of gynaecological, rectal or anal cancer
2. 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
3. aged 18 years or older
4. able to read and write English, and give written, informed consent
5. able to complete quality of life instruments
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

Exclusion Criteria

1. severe psychiatric, cognitive or physical disorder that would preclude them from inserting an applicator
2. receiving radiotherapy for recurrent disease
3. had estrogen receptor positive breast cancer within last 5 years
4. 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified