VCCC Investigator-Initiated Trial Building Capability Program: Clinical trials target common symptoms

Monday 20 May 2019

Cancer clinical trials predominantly focus on new therapies to control cancer. However, patients with cancer commonly
experience symptoms not directly related to the cancer itself. These symptoms can have a significant impact on the
patient’s quality of life, as well as that of family and carers.

Through the Victorian Comprehensive Cancer Centre (VCCC) Investigator-Initiated Trial Building Capability Program, the
VCCC has announced funding for two new investigator-initiated clinical trials addressing the treatment of two significant
symptoms in cancer patients: changes in taste during chemotherapy and insomnia in the palliative care setting. A third
trial is targeting treatments on a personalised, molecular level.

The VCCC is investing in investigator-initiated trials to expand and diversify fields of research, as well as increase
workforce capability, enabling new innovations to improve cancer outcomes.

Investigator-initiated trials are established and managed through a hospital, medical research institute or university,
rather than a pharmaceutical or biotechnical organisation. This trial approach can address research areas that
pharmaceutical or biotech industries are less likely to invest in.

Reducing symptoms to improve quality of life: taste and sleep
Austin Health Chemotherapy Day Unit Nurse Unit Manager, Angela Mellerick is the principal investigator for the trial
that will test a novel treatment to improve chemotherapy related taste problems.

Ms Mellerick said, “Changes in taste during chemotherapy is a common symptom, however the cause is not well
understood, and patients can be affected for many months or more.”

“The VCCC program provides our trial group with support mechanisms to initiate a trial, such as protocol writing,
database build, regulatory documents, ethics submission and financial management. These resources provide nurses,
allied health practitioners and early career researchers with skills and experience through the process.”

Western Health medical oncologist and palliative care physician, Dr Ruwani Mendis, is examining insomnia symptoms
associated with palliative care. “Trials in palliative care improves patient quality of life and provides standards for the
very best of care in a challenging situation,” he said.

“Clinical trials in the palliative care area are relatively new, the VCCC’s program helps remove barriers and enables
coordination between hospitals and research staff, providing benefits to patients sooner.”

Changing the landscape of clinical trials in Australia
VCCC Clinical Trials Development Lead, Professor Mark Rosenthal said, “Investigator-initiated trials are the number one
unmet need in the field of cancer clinical trials. This method of funding and support gives potential investigators with
the means to lead a trial, from idea to protocol development.”

The third trial supported by the VCCC program will implement of a novel ‘umbrella’ trial design. Professor Rosenthal
said, “This is an exciting development and the trial will use results from molecular testing in the VCCC Precision
Oncology Program to direct treatment decisions where targeted therapies are available. These clinical trials are
changing how patients with cancer can access treatment; truly providing personalised medicine.”

In the last 12 months, the VCCC Investigator-Initiated Trial Building Capability Program has supported six clinical trials,
potentially impacting 6,000 patients locally, nationally and internationally.

The VCCC is currently developing research focused concept development workshops to provide a hands-on approach to
idea generation and protocol development. Expressions of interest for the next round of investigator-initiated trial
support will be opened in July.

For further information regarding the program, contact Kate Khamly, Program Manager: kate.khamly@unimelb.edu.au.

Acknowledgement

The VCCC Investigator-Initiated Trial Building Capability Program is supported by the Victorian Government.

Enquiries Lee Byrne | Communications Manager | lee.byrne@unimelb.edu.au | 0479 184 550

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