ACTRN12621001366842
Recruiting
Phase 2
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.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Western Sydney Local Health District
- Enrollment
- 45
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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