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Trial registered on ANZCTR


Registration number
ACTRN12611001249943
Ethics application status
Approved
Date submitted
30/11/2011
Date registered
6/12/2011
Date last updated
2/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Sexuality After Breast Cancer
Scientific title
Silicone-based vaginal lubricant vs water-based vaginal lubricant for symptomatic vaginal dryness after breast cancer treatment: a randomised trial
Secondary ID [1] 273503 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vaginal dryness 279302 0
Condition category
Condition code
Renal and Urogenital 279496 279496 0 0
Other renal and urogenital disorders
Cancer 279533 279533 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
First silicone-based lubricant then water-based lubricant
or
First water-based lubricant then silicone-based lubricant.
Both lubricants are safe and available and widely used as over the counter preparations. Participants should apply a small amount of lubricant around the entrance of the vagina prior to sexual activity or intercourse. Each lubricant will be used as determined by the user for 1 month before changing to the alternative lubricant. There will be no washout period between lubricants.
Intervention code [1] 283820 0
Treatment: Other
Comparator / control treatment
Non-hormonal lubricants. Active control. Crossover design.
The water based lubricant will be deemed the control in this study.
Control group
Active

Outcomes
Primary outcome [1] 286057 0
To compare the efficacy and acceptablility of a silicone-based vaginal lubricant vs. a water-based lubricant in breast cancer patients with symptomatic vaginal dryness using a randomised AB/BA cross-over design. We will evaluate vaginal dryness using both subjective and objective measures. The vaginal Health Assessment will be assessed by the study doctor and Sexual Activity Questionnaire (SAQ) Discomfort subscale complete by the participant.
Timepoint [1] 286057 0
These measures will be completed before commencement of the preparation. Again at 1 month following completion of the first preparation and then again at 2 months after completion of the second preparation.
Primary outcome [2] 286100 0
We will evaluate discomfort at intercourse using objective measures. The Sexual Activity Questionnaire (SAQ) Discomfort subscale and Female Intervention Efficay Index (FIEI).
Timepoint [2] 286100 0
These measures will be completed before commencement of the preparation. Again at 1 month following completion of the first preparation and then again at 2 months after completion of the second preparation.
Primary outcome [3] 286101 0
We will evaluate sexual activity using a sexual activity diary and patient perceived efficacy will be measured using standardised and validated scales (sexual Activity Questionnaire (SAQ) Discomfort subscale , the Female Intervention Efficay Index (FIEI)
Timepoint [3] 286101 0
The diary will be completed by the participant daily during the duration of the study. Other measures will be completed before commencement of the preparation. Again at 1 month following completion of the first preparation and then again at 2 months after completion of the second preparation.
Secondary outcome [1] 295058 0
To evaluate sexual function and quality of life using the Sexual Activity Questionnaire, general quality of life using the Functional Assessment of Cancer Therapy for Patients with Breast Cancer (FACT-B), endocrine symptoms using the Functional Assessment of cancer Therapy for Patients with Endocrine Symptoms (FACT-ES, and distress using the Female Sexual Distress Scale-Revised.
Timepoint [1] 295058 0
These measures will be completed before commencement of the preparation. Again at 1 month following completion of the first preparation and then again at 2 months after completion of the second preparation.
Secondary outcome [2] 295148 0
We will assess vaginal condition using a standardised visual method and patient acceptability of the products. Since anxiety and depression after breast cancer may also affect sexual function, we will measure these factors using the standardised Hospital Anxiety and Depression Scale (HADS).
Timepoint [2] 295148 0
These measures will be completed before commencement of the preparation. Again at 1 month following completion of the first preparation and then again at 2 months after completion of the second preparation.

Eligibility
Key inclusion criteria
History of breast cancer
Sexually active and symptoms of vaginal dryness or dyspareunia
Will to be randomised to try both products
Willing to complete daily sexual activity diary
Normal pap smear in last 2 years if retains uterus
Minimum age
No limit
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Taking systematic or vaginal oestrogen or Tibolone in the previous 6 weeks
Current symptoms of vaginal infection
Post menopausal bleeding
Allergy to silicone-based lubricants
Clinically significant anxiety or depression

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment. Sealed numbered opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by a computer software (i.e., computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 284294 0
Commercial sector/Industry
Name [1] 284294 0
pjur group Luxembourg S.A.
Address [1] 284294 0
87, Esplanade de la Moselle
6637 Wasserbillig
Luxembourg
Country [1] 284294 0
Germany
Primary sponsor type
Individual
Name
Professor Martha HIckey
Address
The Royal Women's Hospital
Cnr Grattan Street and Flemington Road
Parkville
Victoria 3052
Country
Australia
Secondary sponsor category [1] 283244 0
None
Name [1] 283244 0
Address [1] 283244 0
Country [1] 283244 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286256 0
Royal Women Hospital Ethics Committee
Ethics committee address [1] 286256 0
Cnr Grattan Street and Flemington Road, Parkville 3052
Ethics committee country [1] 286256 0
Australia
Date submitted for ethics approval [1] 286256 0
26/10/2011
Approval date [1] 286256 0
20/12/2011
Ethics approval number [1] 286256 0
11/57

Summary
Brief summary
Vaginal dryness and dyspareunia (pain occurring during sexual intercourse) is a common consequence of treatment for breast cancer and has been identified as one of the most common and troublesome consequences for survivors. Vaginal dryness and pain during sexual intercourse significantly negatively impacts on quality of life. With improved survival from breast cancer the absolute number of breast cancer patients affected by symptomatic vaginal dryness and dyspareunia is likely to increase.

Systemic or topical (vaginal) estrogens are an effective treatment for symptoms of vaginal dryness. However, the safety of vaginal oestrogens after breast cancer is not established.
Water-based lubricants are widely used and silicone based lubricants are also available for vaginal lubrication. However, the relative effectiveness and acceptability of these products is not known. No previous studies have evaluated silicone-based vaginal lubricants for the treatment of vaginal dryness and dyspareunia after breast cancer or compared these with water-based lubricants.
Aims: The primary aim of this study is to compare the efficacy and acceptability of a silicone-based vaginal lubricant vs. a water-based lubricant in breast cancer patients with symptomatic vaginal dryness using a randomised cross over design. The Secondary Objective is to clinically assess the symptoms and signs of vaginal dryness, evaluate quality of life and sexual function using established questionnaires.
Study Population: 40 subjects with a history of breast cancer complaining of vaginal dryness will be recruited from the Menopause After Cancer Clinic (MSAC) at The Royal Women’s Hospital Melbourne (RWH), the RWH Breast Clinic, oncologist practices in Victoria and community based breast cancer organisations such as the Breast Cancer Network Australia and by media advertising.

Methods: To participate in this study subjects must have a history of breast cancer, be sexually active and be complaining of vaginal dryness for at least 4 weeks. Subjects will be asked to attend 3 clinic visits.

Ethical Issues: Subjects will be asked to complete questionnaires including details of sexual problems and function and to complete a sexual activity diary. Subjects will be fully informed of the requirements before enrolling in the study and able to withdraw at any time without compromising their care. These vaginal lubricants are not systemically absorbed and are extremely unlikely to impact on breast cancer management or prognosis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33467 0
Address 33467 0
Country 33467 0
Phone 33467 0
Fax 33467 0
Email 33467 0
Contact person for public queries
Name 16714 0
Professor Martha Hickey
Address 16714 0
7th Floor Research Precinct
Royal Women's Hospital
Cnr Grattan Street and Flemington Road
Parkville
Victoria 3052
Country 16714 0
Australia
Phone 16714 0
+61 3 8345 3719
Fax 16714 0
+61 3 8345 3702
Email 16714 0
martha.hickey@thewomens.org.au
Contact person for scientific queries
Name 7642 0
Doctor Jennifer Marino
Address 7642 0
7th Floor Research Precinct
Royal Women's Hospital
Cnr Grattan Street and Flemington Road
Parkville
Victoria 3052
Country 7642 0
Australia
Phone 7642 0
+61 3 8345 3719
Fax 7642 0
+61 3 8345 3702
Email 7642 0
jennifer.marino@unimelb.edu.au

No data has been provided for results reporting
Summary results
Not applicable