ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Vaginal dryness

Condition category

Condition code

Renal and Urogenital

Other renal and urogenital disorders

Cancer

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]

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]

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]

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]

We will evaluate discomfort at intercourse using objective measures. The Sexual Activity Questionnaire (SAQ) Discomfort subscale and Female Intervention Efficay Index (FIEI).

Timepoint [2]

Primary outcome [3]

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]

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]

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]

Secondary outcome [2]

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]

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

Sex

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

30/01/2012

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]

Commercial sector/Industry

Name [1]

pjur group Luxembourg S.A.

Address [1]

87, Esplanade de la Moselle
6637 Wasserbillig
Luxembourg

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Women Hospital Ethics Committee

Ethics committee address [1]

Cnr Grattan Street and Flemington Road, Parkville 3052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/10/2011

Approval date [1]

20/12/2011

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Professor Martha Hickey

Address

7th Floor Research Precinct
Royal Women's Hospital
Cnr Grattan Street and Flemington Road
Parkville
Victoria 3052

Country

Australia

Phone

+61 3 8345 3719

Fax

+61 3 8345 3702

martha.hickey@thewomens.org.au

Contact person for scientific queries

Name

Doctor Jennifer Marino

Address

7th Floor Research Precinct
Royal Women's Hospital
Cnr Grattan Street and Flemington Road
Parkville
Victoria 3052

Country

Australia

Phone

+61 3 8345 3719

Fax

+61 3 8345 3702

jennifer.marino@unimelb.edu.au

No information has been provided regarding IPD availability

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.

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