None listed
Conditions
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.
Interventions
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
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.
Sponsors
Professor Martha HIckey
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
Yes
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
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
Outcome results
None listed