Care Oncology Clinic
Launched in 2013, the Care Oncology Clinic (COC) was established to provide a new kind of cancer treatment – a combination of oral medications specifically designed to target the metabolism of cancer, depriving cancer of the nutrients it needs to grow and spread.
The COC Protocol
The clinic’s proprietary COC Protocol addresses an unmet medical need by filling a gap in current cancer therapeutics. The treatment, which uses existing drugs, prescribed off-label, aims to complement and enhance standard of care cancer therapies.
Delivery of this metabolic treatment programme in a clinic setting with data collection and analysis is what makes it unique.
- What is off-label prescribing?
- Why aren’t these drugs already being used in cancer?
- Why use a combination or “cocktail” of medicines?
- Who is the COC Protocol for?
- How are patients assessed and monitored?
- How is treatment administered?
- How quickly will there be results?
- How long should a patient take the COC protocol?
- What are Care Oncology Clinic’s results so far?
What is off-label prescribing?
Prescribing off-label, also known as drug repurposing, repositioning, or reprofiling, is the application of known drugs to treat a different disease. It takes advantage of the many “off-target” effects of already-approved medicines to treat new diseases. When done carefully, this practice can have several important advantages. First, the drugs have typically been widely prescribed, therefore the safety profile and side-effects are well-known and documented. Second, there is an extensive body of peer-reviewed, published research which can be reviewed and interrogated.
Why aren’t these drugs already being used in cancer?
This is mostly due to financial reasons. Drugs that are candidates for off-label prescribing or repurposing are typically off-patent and available generically. Therefore, there is no obvious incentive for pharmaceutical companies to spend the money required to label these for a new disease.
Care Oncology was conceived to bridge this gap – to realise the potential of bringing a safe, evidence-based and accessible treatment option to patients and to collect data to report on patient outcomes with the aim of helping to change the wider cancer treatment landscape.
Why use a combination or “cocktail” of medicines?
It is well-established that cancer therapies may be most effective when used in combination – for example, concurrent chemotherapy and radiotherapy or chemotherapy regimens which involve more than one agent. With a low toxicity metabolic treatment, it is especially important to ensure multiple points of intervention and to target a number of metabolic and signalling pathways within the cancer cell.
The medications used in the COC Protocol were identified after analysing a huge number of potential candidates. Our scientists and doctors conducted detailed examinations of drug biology and associated anticancer data and final drug selection was based on the strength of the evidence in several key areas, including:
- Potential to target and slow down the progression of cancer
- Predicted capacity to work together in a complementary way against cancer
- Capacity to enhance the activity of conventional cancer treatments
- Established drug tolerance and safety profiles
Who is the COC Protocol for?
The COC Protocol is available to cancer patients aged 18 and over with disease of any type or stage. Altered metabolic features have been observed across many different types of solid tumour and blood cancers and reprogrammed metabolism is now considered a general ‘hallmark’ of cancer.
Patients engage with Care Oncology Clinic at different points in their cancer journey. You could be someone who has:
- a new diagnosis and is about to begin systemic treatment for a type of cancer which carries a risk of progression or recurrence
- completed a course of cancer treatment and is on active surveillance
- no evidence of disease (NED) but is at risk of recurrence
- disease progression and commencing further lines of therapy
- commenced palliative care
As long as a patient is relatively well in themselves (able to swallow oral medication, getting adequate nutrition, not confined to bed, not suffering from severe and prolonged nausea) and has satisfactory baseline blood results and organ function, they could be eligible for treatment.
How are patients assessed and monitored?
A cancer diagnosis is life changing. For many patients, treatment is complex and involves major interventions such as surgery and radiotherapy. Medications may include chemotherapy, immunotherapy, or hormone therapy, as well as supportive medicines to manage nausea and pain. The drugs used to treat cancer are aggressive and can cause serious adverse effects if the dosage is too high or be ineffective in treating the disease if the dosage is not high enough.
Therefore, it is critically important that the addition of further treatment be undertaken with expert medical oversight.
New patient assessment
Care Oncology Clinic doctors will:
- Conduct a careful evaluation of each case to assess the potential benefits and risks involved in recommending the COC Protocol.
- Review the medical history, overall health status, blood test results, current cancer treatment and other medications being taken, to ensure the COC Protocol dosing regimen is carefully tailored to each patient’s unique situation and circumstances.
- Only recommend the COC Protocol to a patient when they believe it will be safe and beneficial to do so.
Follow up and monitoring
Continued medical supervision is central to the clinic’s service given that each patient’s health status, blood test parameters, standard of care treatment and other circumstances evolve over time.
8-week Follow Up appointments are scheduled for new patients during which a first set of interval blood results will also be reviewed. This ensures patient safety during the initial treatment phase and enables any necessary adjustments to consolidate the introduction of the regimen. Your doctor will review each COC medication, interval test results, changes to concurrent treatments/medications and answer any questions you may have.
Quarterly Review appointments are scheduled to discuss how treatment is progressing and to take account of additional clinical information (e.g., ongoing interval blood results and scan reports, introduction of new treatments/medicines).
In between the formal quarterly appointments, there are no additional costs for contact by telephone or email for follow up questions or concerns and we also operate an Out of Hours telephone service.
How is treatment administered?
All the medicines are oral formulations to be taken at home. The Protocol is designed to be taken alongside standard of care cancer treatments wherever the opportunity arises – evidence suggests that disrupting a cancer cell’s ability to access and use the nutrients it needs to grow and multiply makes it more difficult for the cell to survive in a hostile environment i.e. during chemotherapy, radiotherapy, hormone therapy and immunotherapy.
In situation where it is not possible, or for some reason, not desirable to undertake conventional cancer treatment, the COC Protocol may be effective on its own.
How quickly will there be results?
The nature of our treatment, with its metabolic mechanism of action (impacting cancer cells’ access to and processing of the specific sources of energy they need, and modulating the genetic expression of important oncogenic pathways) means it is likely to be slower acting — several months rather than weeks — compared to what are known as cytotoxic therapies such as chemo and radiotherapy.
However, every person has their own specific genetic make-up, and every tumour is unique in its complement of genetic changes and overall metabolic and epigenetic characteristics. Therefore, every patient responds to any therapy differently.
A prospective patient’s prognosis and performance status is a key consideration for us. We always aim to ensure that a patient is well enough to safely proceed with metabolic treatment and for there to be a realistic chance of them deriving some clinical benefit from the Protocol.
How long should a patient take the COC protocol?
All the COC Protocol medications can be safely administered for a long period of time. Patients can take the Protocol as a maintenance regime after standard therapy has been completed, during breaks from standard therapy and/or as part of a long-term strategy to help manage the risk of recurrence or metastatic spread. The clinic conducts follow up appointments every quarter and clinicians make an assessment at each of these checkpoints about whether treatment should continue, considering the current clinical picture, potential for ongoing treatment benefit and the patient’s quality of life.
What are Care Oncology Clinic’s results so far?
Preliminary results from a retrospective analysis of our Glioblastoma Brain Tumour patients was published in June 2019 in Frontiers in Pharmacology – click to read.