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Clinical trials for women who have completed active treatment

Clinical trials play a very important role in a research process to identify improved treatment options. Clinical trials test new and better ways of improving health in people and the following trials look at ways of improving a person’s quality of life in women who have completed active treatment of their breast cancer.

Randomised trial of MonaLisa TouchTM for women with vaginal atrophy and a history of breast cancer

Researchers are currently running a clinical trial in Australia which will evaluate how effective MonaLisa TouchTM is in treating postmenopausal vaginal atrophy symptoms in women.

MonaLisa TouchTM is a new, non-hormonal treatment for women with vaginal atrophy (VA). VA most commonly occurs after menopause, when oestrogen levels fall and the walls of the vagina become thinner, drier and may become inflamed. VA also affects women who have had breast cancer, where medications affect oestrogen levels and bring on menopausal symptoms. This often distressing condition can cause painful burning, itching, dryness, painful intercourse and pain during urination.

MonaLisa TouchTM is a type of fractional CO2 laser technology treatment which involves pin-point laser applications to the vaginal lining.  At present, there is not enough evidence about the effectiveness of MonaLisa TouchTM for it to be recommended as a medical treatment. It is currently expensive to access and there is no Medicare rebate available.

This study is open to women who:

  • have significant VA symptoms and
  • do not wish to take hormone replacement therapy (vaginal tablet/cream, oral tablet or skin patch) because of a history of breast cancer.

The study is being conducted in Sydney at the Royal Hospital for Women.

If you are interested in this study or would like to know whether you are eligible to participate, you can contact Associate Professor Jason Abbott:

  • Phone: 0491 231 771
  • Email: j.abbott@unsw.edu.au

Pregnancy after breast cancer trial

The POSITIVE trial is an international study led by the International Breast Cancer Study Group worldwide. This trial is for women wanting to become pregnant after breast cancer. The researchers are recruiting young women with oestrogen receptor positive (ER+) breast cancer who wish to interrupt hormone therapy (e.g. tamoxifen) to attempt to conceive a baby. In Australia, this trial is currently only available at the St John of God Subiaco Hospital, Perth.

The POSITIVE trial is enrolling women who meet the following criteria:

  • Pre-menopausal status
  • Hormone-sensitive early breast cancer
  • Aged 18 to 42
  • Endocrine therapy for 18 to 30 months
  • Wish to interrupt endocrine therapy to attempt pregnancy

The study involves the interruption of hormone treatment for up to 2 years in order to attempt pregnancy.

Participation will involve brief three-monthly clinic visits, blood samples that are collected at 3, 6 and 12 months, and a pelvic ultrasound performed at 3 and 6 months. There are also some optional questionnaires the researchers would like trial participants to complete.

If you are interested in participating in this trial, or would like more information, please email the Principal Investigator, Professor Christobel Saunders, at christobel.saunders@uwa.edu.au or contact the Clinical Trial Unit Staff on (08) 6465 9204.

Cognitive Rehabilitation for Breast Cancer Survivors with Perceived Cognitive Impairment 

Cognitive impairment is a common side effect of chemotherapy and affects function and quality of life. There is no proven effective treatment for this impairment. This research project will compare two treatments to determine which, if either, is more beneficial. It is being carried out at hospitals in Sydney.

The trial is currently enrolling women who meet the following criteria: 

  • completed chemotherapy for early breast cancer at least 6 months ago and whose cancer has not spread beyond the breast and lymph nodes
  • currently free of breast cancer
  • able to speak and read English
  • have noticed changes in their memory, concentration and thinking since diagnosis and treatment

There will be a questionnaire to make sure this study is suitable for you. Then, in order to compare the effectiveness of each method of treatment, participants will be randomly allocated into one of three groups. 

Group 1 (Attention Process Training small group sessions) and Group 2 (Compensatory Strategies small group sessions)

Once a week for 6 weeks, you will be asked to visit a hospital to participate in a 2 hour program in small groups. Group 1 will undergo a structured program to develop brain processes and Group 2 will discuss strategies to manage changes in cognition. Both groups will be asked to complete 2 hours of homework each week and in the 7th week will be asked to visit the hospital again to participate in a final group discussion.

Group 3 (Standard care)

This group will maintain their follow-up as usual with their treating clinicians and other health professionals. At the completion of the study they will be invited to participate in either of the cognitive rehabilitation programs if they are found to be more effective than standard care.

Everyone participating in the study completes neuropsychological assessments four times: once before starting the trial, at about 8 weeks after starting the trial, then again at 6 and 12 months. The assessments involve working through a series of exercises designed to see any changes in your memory, concentration and thinking.

The trial is being conducted by the University of Sydney. Funding for this research comes from Conquer Cancer Foundation of ASCO.  

For more information, or to register, please visit the Register4 website.