������

“I was offered 25 sessions of radiotherapy which I had continually for five weeks and every Wednesday I had chemotherapy alongside it. It was all consuming and very tiring and on the third week of my chemo I had an allergic reaction to it. After five weeks of chemo, I had sessions of brachytherapy. I did also have some surgery to remove some cancerous cells in other parts of my body.”

Sonia has now been in remission for just over a year and has gone from three monthly scans to four monthly scans. But she says she is still experiencing the side-effects of her treatment.

“I’ve gone through the early menopause, and I do get quite bad hips which are really stiff, and I can’t stand up straight away. I’ve also experienced lots of scar tissue from the radiation which I have had to have removed but it continues to grow and can be quite problematic. I have been given exercises to do to try to help with it but new treatments that could reduce those side effects and make the treatment easier would be really beneficial. Any treatment that can help people get better, quicker is welcome.”

Sonia has now joined the team at the Southampton Clinical Trials Unit to act as a patient ambassador on the CRAIN trial. This trial will look at whether adding a new drug called tolinapant to standard treatment for cervical cancer can help to destroy cancerous cells and improve outcomes for patients.

The trial is being led in Southampton by Dr Vicky McFarlane, Consultant Clinical Oncologist at University Hospital Southampton (UHS) who specialises in gynaecological cancers.

“We currently treat most cases of locally advanced cervical cancer by giving people chemotherapy and radiotherapy at the same time,” says Dr McFarlane. “But unfortunately, many patients will suffer long-term side effects from the treatment, and a proportion will see their disease come back. We therefore need to find new treatments that can eradicate the cancer more effectively and see fewer patients relapsing.”

One of the hallmarks of cancer cells is that they can avoid a process called apoptosis. This is the mechanism of programmed cell death that is part of all normal cells in the body and ensures that damaged or old cells are removed. But in cancerous cells, the mechanism that causes apoptosis is switched off, which means the cells can grow uncontrollably, causing a tumour.

Tolinapant causes apoptosis in cells and the CRAIN trial will therefore look at whether this drug could be a beneficial addition to standard treatment.

Marina Lee, trial manager for the CRAIN trial at the Southampton Clinical Trials Unit, says: “Studies in the laboratory have shown that adding this drug to chemoradiotherapy can increase the number of cancer cells that are destroyed, compared to radiation alone. This early phase clinical trial will help us to find a suitable dose of tolinapant that can be safely tolerated by patients and give us an indication of whether it is effective against their cancer.”

Around 3,200 people are diagnosed with cervical cancer in the UK each year, which equates to around nine new cases each day.

“People tend to think ‘cancer will never happen to me’ and you generally don’t think too much about it until you’re in that situation,” says Sonia. “If there are new drugs to try for people who are in the position I was once in, that’s great news. But it’s vitally important that people donate to help fund research and trials like this so that progress can keep being made.”

The CRAIN trial aims to recruit 42 patients at six hospitals around the UK over the next two years. It recently opened at The Christie in Manchester and is due to begin at University Hospital Southampton (UHS) in the coming weeks.

Dr Karen Underwood, Director of Research & Development (R&D) at UHS, says: “Clinical research has a vital role to play in improving current treatments, medicines and care, and developing new and better ones. I am delighted that we are opening CRAIN trial in Southampton, which will draw upon our world-class research infrastructure and close working between the Southampton Clinical Trials Unit, the NIHR Southampton Clinical Research Facility, and the CRUK Southampton Experimental Cancer Medicine Centre.”

Dr McFarlane continues: “If this first trial is successful, the hope is that it will lead to a larger trial where we can test whether the addition of tolinapant to our current treatment with radiotherapy and chemotherapy will work better than chemoradiation treatment alone. We hope that with this research we can improve outcomes and survival rates for people with cervical cancer.”

The trial is being funded by nearly £700,000 of funding from Cancer Research UK and is supported by ASTEX Pharmaceuticals who manufacture tolinapant and are providing the drug for the trial.