Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621001366842
Ethics application status
Approved
Date submitted
30/08/2021
Date registered
11/10/2021
Date last updated
28/09/2022
Date data sharing statement initially provided
11/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Vaginal Oestriol to prevent vaginal stenosis (VESPA).
Scientific title
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.
Secondary ID [1] 304854 0
None
Universal Trial Number (UTN)
Trial acronym
VESPA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vaginal stenosis following radiotherapy 322952 0
Condition category
Condition code
Cancer 320525 320525 0 0
Cervical (cervix)
Cancer 320629 320629 0 0
Womb (Uterine or endometrial cancer)
Cancer 320631 320631 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 320632 320632 0 0
Bowel - Anal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 321309 0
Prevention
Intervention code [2] 321729 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328444 0
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.
Timepoint [1] 328444 0
12 months post end of radiotherapy
Primary outcome [2] 328445 0
The incidence of stenosis as measured by the LENT-SOMA scale on the basis of clinical assessment.
Timepoint [2] 328445 0
12 months post end of radiotherapy
Primary outcome [3] 328446 0
Safety - measured using the serum levels of oestradiol and FSH in blood tests taken at regular intervals.
Timepoint [3] 328446 0
Assessed at every treatment appointment up to 12 months post end of radiotherapy
Secondary outcome [1] 399032 0
Sexual function and vaginal symptoms - measured by the Sexual-function-Vaginal changes Questionnaire (SVQ). This will be assessed as a composite outcome.
Timepoint [1] 399032 0
12 months post end of radiotherapy
Secondary outcome [2] 399033 0
Health-related quality of life – patient reported outcome measures (FACT-G)
Timepoint [2] 399033 0
12 months post end of radiotherapy
Secondary outcome [3] 401015 0
Safety – measured by the collection and analysis of Serious Adverse Events and Adverse Events.
Timepoint [3] 401015 0
Assessed at every treatment appointment up to 12 months post end of radiotherapy, or 4 weeks after last study treatment if patients discontinues due to Adverse Event. Assessed via study-specific form including CTCAE grading.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
For this phase II pilot, based on Simon’s two-stage design, 30 patients provide 80% power with 95% confidence to rule out a 25-30% stenosis rate in favour of a 7-10% with the use of vaginal oestriol.
Summary measures will include frequencies and proportions presented with their corresponding 95% confidence intervals. Comparisons of proportions will be performed using chi-squared or exact tests (e.g., conditional binomial) and continuous outcomes will be analyzed by using t-tests or suitable non-parametric methods if appropriate. For binary outcomes logistic regression analysis will be employed where adjustment for prognostic factors is mediated.
Stenosis free survival will be analyzed using time-to-event methods including the log-rank test and Cox proportional hazards regression models. Kaplan-Meier survival curves will be constructed for graphical display. Actuarial event-free survival rates will also be calculated with suitable 95% confidence intervals.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
28/05/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
30
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 20115 0
Westmead Hospital - Westmead
Recruitment hospital [2] 20116 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [3] 20117 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 20118 0
Gold Coast University Hospital - Southport
Recruitment hospital [5] 20119 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [6] 20530 0
Prince of Wales Private Hospital - Randwick
Recruitment postcode(s) [1] 34823 0
2145 - Westmead
Recruitment postcode(s) [2] 34824 0
2298 - Waratah
Recruitment postcode(s) [3] 34825 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 34826 0
4215 - Southport
Recruitment postcode(s) [5] 34827 0
4029 - Herston
Recruitment postcode(s) [6] 35312 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 309227 0
Hospital
Name [1] 309227 0
Westmead Hospital, Department of Gynaecological Oncology
Country [1] 309227 0
Australia
Funding source category [2] 309293 0
Government body
Name [2] 309293 0
Cancer Institute NSW via SWTCRC
Country [2] 309293 0
Australia
Primary sponsor type
Government body
Name
Western Sydney Local Health District
Address
Westmead Hospital
PO Box 533, Wentworthville, NSW 2145
Country
Australia
Secondary sponsor category [1] 310328 0
None
Name [1] 310328 0
Address [1] 310328 0
Country [1] 310328 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309075 0
Western Sydney Local Health District HREC
Ethics committee address [1] 309075 0
Research and Education Network
Westmead Hospital, PO Box 533, Wentworthville, NSW 2145
Ethics committee country [1] 309075 0
Australia
Date submitted for ethics approval [1] 309075 0
Approval date [1] 309075 0
05/03/2014
Ethics approval number [1] 309075 0

Summary
Brief 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112886 0
A/Prof Alison Brand
Address 112886 0
Department of Gynaecological Oncology
Westmead Hospital
PO Box 533,
Wentworthville, NSW 2145
Country 112886 0
Australia
Phone 112886 0
+61 2 8890 6801
Fax 112886 0
Email 112886 0
[email protected]
Contact person for public queries
Name 112887 0
Ms Kate Campbell
Address 112887 0
Department of Gynaecological Oncology
Westmead Hospital
PO Box 533,
Wentworthville, NSW 2145
Country 112887 0
Australia
Phone 112887 0
+61 2 8890 6347
Fax 112887 0
Email 112887 0
[email protected]
Contact person for scientific queries
Name 112888 0
Ms Kate Campbell
Address 112888 0
Department of Gynaecological Oncology
Westmead Hospital
PO Box 533,
Wentworthville, NSW 2145
Country 112888 0
Australia
Phone 112888 0
+61 2 8890 6347
Fax 112888 0
Email 112888 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.