SUPPORTIVE CARE TRIALS

Supportive care trials focus on improving the quality of life for people with breast cancer, including: post-surgery rehabilitation, management of treatment side-effects, palliative care, integrative care (emotional and social needs, complementary therapies).

Clinical Trials in this section are currently recruiting (open to new patients) or pending for patients at varying stages of their breast cancer treatment. Unlike drug trials, many of these trials will be available to a wide range of breast cancer patients.

We’ve made every effort to ensure this information is accurate, but you’ll need to talk to your doctor or contact the trial coordinator to find out more about whether a trial is suitable for you. Are we out of date? If you have updated or new information about a trial, we’d be grateful if you’d share it with us – email your update to ClinicalTrials@nzbcf.org.nz.

 

Supportive Care Trials in New Zealand

  • Supportive Care Trials

     

  • REGISTER YOUR INTEREST

    Tell us if you’re interested in joining a clinical trial.
    We’ll keep searching for new studies
    ClinicalTrials@nzbcf.org.nz

  • QoLID (Recruiting)
    Choice of breast reconstruction and quality of life for women undergoing a mastectomy and radiotherapy for breast cancer.

  • QoLID (Recruiting)

    Updated: May 15th, 2016

    This study will assess the quality of life in women with breast cancer, who undergo mastectomy and post-mastectomy radiotherapy (PMRT). This will be focussed on participants with early or local breast cancer.

    All participants in this study will be asked to complete a number of questionnaires over a period of 5 years post-mastectomy in order to assess quality of life, pain, aesthetic outcomes and clinical outcomes. If immediate breast reconstruction (IBR) is found to improve the quality of life of patients who are undergoing mastectomy and subsequent adjuvant treatments, then IBR could be offered as an option to breast cancer patients who are reasonable candidates for this procedure. This will be the first prospective cohort study in Australia and New Zealand to assess the quality of life of women undergoing mastectomy and PMRT, and allows for comparison of outcomes according to breast reconstruction choices - immediate, delayed or none.

    Run by: Breast & Surgical Oncology at the Pouche Centre at Waikato Hospital (Contact Jenni Scarlet 07 8398726 Ext 97916 Jenni.Scarlet@waikatodhb.health.nz), New Zealand and at various locations in Australia – View full trial description and contact details.

Supportive Care Trials in Australia.

  • Supportive Care Trials

     

  • REGISTER YOUR INTEREST

    Tell us if you’re interested in joining a clinical trial.
    We’ll keep searching for new studies
    ClinicalTrials@nzbcf.org.nz

  • AREA (Recruiting)
    A randomised study to evaluate the impact of Aerobic and Resistance Exercise on fatigue in patients with advanced breast cancer. The study will assess the feasibility of a specified exercise program in patients with advanced breast cancer and its impact on improving fatigue.

    PEGASUS (Recruiting)
    A study of the prevalence and severity of genitourinary symptoms in postmenopausal women receiving adjuvant endocrine therapy for early stage breast cancer and impact on sexual function and quality of life.

    Cardiac MRI (Recruiting)
    Cardiac Magnetic Resonance Imaging and echocardiography in the detection of cardiotoxicity in cancer patients: A feasibility study

    QoLID (Recruiting)
    A multicentre prospective study assessing the impact of risk-reducing bilateral salpingo-oophorectomy on non-cancer outcomes in young high-risk women.

    Bioimpedance Spectroscopy Versus Tape Measure in Prevention of Lymphedema (Recruiting)
    A randomized clinical trial in which participants are randomized post-surgery to either BIS or circumferential (tape) measurements for follow-up arm measurements.

    Efficacy and safety of Ginkgo Biloba (Recruiting)
    This study looks at the effectiveness and safety of treatment with the herb ginkgo biloba in preventing or reducing changes in thinking, memory and concentration (cognitive function) experienced by some women during and after treatment with chemotherapy for early breast cancer.

    Preventing “Chemo-Brain” (Recruiting)
    Can exercise mitigate chemotherapy-induced cognitive impairment in breast cancer patients?

    Wearable Technology (Recruiting)
    Preferences for wearable technology activity monitors after breast cancer.

    I-BREAST (Recruiting)
    Improving breast reconstruction equity of access through stakeholder consultation and translation into policy and practice

  • AREA (Recruiting)

    Updated: November 9th, 2015

    You may be eligible to join this study if you are a female with metastatic breast cancer aged between 18-80 years, and are being managed at the Mount Hospital, Perth, WA. Eligible women will also have experienced subjective fatigue in the past several weeks as a persistent symptom.

    This study will be conducted in two parts. In Part 1, eligible patients will be offered a 6 week exercise program, where the primary endpoint will be to assess feasibility and overall safety. If the program is deemed as being feasible and safe, Part 2 of the study will commence. In Part 2, participants will be randomly (by chance) allocated to one of two groups. Participants in one group will be offered the 6 week exercise program, whilst participants in the other group will not participate in the exercise program. On completion of the program, participants will be asked to complete some questionnaires to assess their levels of fatigue, depression and pain. They will also be asked to conduct a brief walking test to assess any changes in aerobic fitness.

    Run by: Breast Cancer Research Centre at Mount Hospital, Western Australia – View full trial description and contact details. See also: https://www.cancerwa.asn.au/patients/making-decisions-about-treatment/clinical-trials/wa-clinical-trials-registry/breast-trials/.

  • PEGASUS (Recruiting)

    Updated: November 1st, 2015

    This study is investigating the prevalence and severity of genitourinary symptoms in postmenopausal women receiving adjuvant endocrine therapy for early stage breast cancer and the impact on sexual function and quality of life.

    You may be eligible to joint this study if you are a postmenopausal female, aged 18 -75 years, with early stage breast cancer and hormone receptor-positive tumours, for which you are about to commence adjuvant endocrine therapy with either tamoxifen (TAM) or aromatase inhibitors (AIs). You will need to be sufficiently competent in English in order to complete the study questionnaires.

    All participants in this study are asked to complete self-administered questionnaires at baseline (prior to starting endocrine therapy), and 6-, 12- and 24-month follow-ups. The standardised questionnaires used relate to genitourinary symptoms, sexual function and quality of life. The findings from this study could be used to identify patients at risk of developing genitourinary symptoms and also to offer appropriate interventions early to prevent and ameliorate such symptoms, which are likely to have a negative impact on quality of life and may contribute to a low compliance with treatment. We believe that this study has the potential to document the extent and impact of genitourinary symptoms in breast cancer survivors about to start adjuvant endocrine therapy and what happens over time. It will also lead to intervention studies in the future.

    Run by: University of New South Wales at various locations in Australia – View full trial description and contact details or contact Mariana Sousa (UNSW), email: m.desouza@unsw.edu.au, phone: 02 99850024.

  • Cardiac Magnetic Resonance Imaging and echocardiography in the detection of cardiotoxicity in cancer patients: A feasibility study (Recruiting)

    Updated: July 18th, 2016

    The primary purpose of this study is to determine the feasibility of using cardiac MRI scans, cardiac ultrasound and blood tests to detect changes in heart function following completion of chemotherapy and/or radiation therapy for cancer.

    Who is it for?

    You may be eligible to join this study if you are aged 18 or over, and have been diagnosed with breast cancer, Hodgkin's lymphoma, Non-Hodgkin's lymphoma, leukaemia or other intra-thoracic/upper gastrointestinal malignancies such as cancer of the oesophagus or thymoma, for which chemotherapy and/or radiotherapy have been prescribed.

    Study details

    All participants in this study will undergo additional cardiac screening tests at timepoints before and after chemotherapy/radiation therapy up to 12 months following the end of therapy. These tests will include MRI scans, cardiac ultrasound scans and blood samples being taken. Results from these tests will be used to assess changes in cardiac function caused by the cancer therapy.

    It is hoped that the findings of this feasibility trial will ultimately aid early identification of heart injury due to cancer therapy, and thus enable prevention strategies and early treatment options in these patients.

    View full trial description and contact details.

  • QoLID (Recruiting)

    Updated: May 15th, 2016

    This study will assess the quality of life in women with breast cancer, from a surgical oncology practice in North Sydney, Australia, who undergo mastectomy and post-mastectomy radiotherapy (PMRT). This will be focussed on participants with early or local breast cancer.

    All participants in this study will be asked to complete a number of questionnaires over a period of 5 years post-mastectomy in order to assess quality of life, pain, aesthetic outcomes and clinical outcomes. If immediate breast reconstruction (IBR) is found to improve the quality of life of patients who are undergoing mastectomy and subsequent adjuvant treatments, then IBR could be offered as an option to breast cancer patients who are reasonable candidates for this procedure. This will be the first prospective cohort study in Australia to assess the quality of life of women undergoing mastectomy and PMRT, and allows for comparison of outcomes according to breast reconstruction choices - immediate, delayed or none.

    Run by: Breast & Surgical Oncology at the Pouche Centre at Waikato Hospital, New Zealand and at various locations in Australia – View full trial description and contact details.

  • DOMINO (Recruiting)

    Updated: November 26th, 2015

    This study aims to find out if a Decision Aid developed to give women information about neoadjuvant treatment for breast cancer is useful in helping them to make a decision about their treatment.

    Who is it for?
    You may be eligible to join this study if you are 18 years or over, have operable invasive breast cancer and are considering whether or not to have neoadjuvant treatment for breast cancer. You will need to have access to the internet and a computer or laptop to read the Decision Aid and complete the questionnaires.

    Trial Details
    Most of this study will be carried out online. If you tell your study doctor that you are interested in the study, you will receive an email with a link to further information about the study and to Consent to participate. You can also consent to participate in a telephone interview, which will take place after participants have accessed the Decision Aid.

    If you consent to the study, you will complete a questionnaire (which will take about 15-20 minutes to do). Once this questionnaire is completed, you will be able to access the Decision Aid; it can be viewed online or can be downloaded and printed.

    After you see your study doctor and make your decision about your treatment, you will receive another email with a link to another questionnaire (15-20 minutes). This will ask you how useful the Decision Aid is and how you feel about your decision about your treatment.

    Another email with a link to more questions (15-20 minutes) will be sent to you after you finish the first part of your treatment (surgery for adjuvant treatment or chemotherapy for neoadjuvant treatment).

    A last email will be sent to you with a link to a questionnaire (15-20 minutes) 12 months after you originally registered for the study.
    View full trial description and contact details. 

  • Bioimpedance Spectroscopy Versus Tape Measure in Prevention of Lymphedema (Recruiting)

    Updated: October 1st, 2016

    Based upon the current state of science, the investigators are proposing to conduct a randomized clinical trial in which participants are randomized post-surgery to either BIS or circumferential (tape) measurements for follow-up arm measurements. When patients in the BIS group have an L-Dex change that is ≥10 units higher than the pre-surgical baseline measure, and when patients in the tape measurement group have a volume change in the at-risk arm that is between ≥ 5% and <10% above pre-surgical baselines (without similar change in non-at-risk arm), both will receive four weeks of 23-32 mm compression sleeve and gauntlet therapy.

    Participants must have historically confirmed invasive breast cancer, a planned surgical procedure and the ability to understand and be willing to sign a written informed consent document.

    Run by: ImpediMed Ltd at various locations in Australia – View full trial description and contact details. See also: https://www.patientslikeme.com/clinical_trials/NCT02167659-Lymphedema-Breast-cancer-Bioimpedance-Spectroscopy-L-Dex.

  • Efficacy and safety of Ginkgo Biloba (Recruiting)

    Updated: November 2nd, 2015

    You can join this phase 3 study if you have diagnosed with early invasive breast cancer and you have had or will have surgery for this, and you also plan have chemotherapy as part of your anti-cancer treatment.

    Participants will be divided into two groups. One group will receive treatment with standardized extracts of the herb ginkgo biloba. The other group will receive a non-active compound (placebo). Both groups will take two tablets (240mg) of study treatment each day for a period of 12 months. Treatment will start about the same time as participants start their chemotherapy treatment.

    All participants will have their cognitive function monitored, along with fatigue, quality of life, blood tests, other possible symptoms, both before treatment and at 3, 6, 12 and 24 months after randomization. Each assessment will take approximately 90 minutes.

    Most women who receive chemotherapy become tired; some complain of memory & concentration problems. Studies have found subtle cognitive impairment ("chemobrain") that can disturb the return to a normal life and there are no known treatments. Ginkgo biloba has been shown to improve cognition in healthy younger volunteers & improve cognition & mood, without side effects, in elderly people.

    Run by: University of Sydney at various locations in New South Wales, Australia – View full trial description and contact details.

  • Wearable Technology Focus Group - ACTIVATE (Recruiting)

    Updated: March 10th, 2016

    Increasing physical activity after breast cancer diagnosis has been shown to improve survival and other health outcomes. This project aims to determine preferences for the types of wearable technology activity monitor, such as fitness bands, for application in increasing physical activity and reducing sitting time among women who have undergone breast cancer.

    You are eligible to take part in this study if you are post-menopausal, have been diagnosed with stage 1-3 breast cancer within the past 5 years and have completed primary treatment at least 6 months ago (ongoing endocrine therapy is acceptable).

    If you decide to take part in this project you will be asked to wear a fitness band and attend a focus group at Cancer Council Victoria (Melbourne).

    View the full trial description to find out more and apply to join.

  • I-BREAST (Recruiting)

    Updated: January 17th, 2017

    The primary purpose of this study is to systematically explore factors behind the low and uneven rates of breast reconstruction across Australia.

    It aims to identify practical ways to improve equity of access for women regardless of where they live, their age and ethnic/cultural backgrounds, and produce acceptable, feasible and readily-translatable recommendations for practice and policy changes to address disparities in women’s breast reconstruction options.

    You may be eligible to participate in this study if you are a woman who has had mastectomy for breast cancer, a breast care nurse, a breast or plastic surgeon or a clinical or policy person involved in making decisions about breast reconstruction.

    The study will primarily involve one-off interviews, either face-to-face or by telephone, with eligible participants. It is hoped that the findings of this study will provide recommendations for practice and policy changes which improve the equity of access to breast reconstruction in Australia.

    View the full trial description for eligibility criteria and contact details.

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