A trial of the cannabis-based drug, Sativex, in treating aggressive brain tumours, has been given the green light.
A Phase II trial of Sativex, in 27 patients with the most severe form of brain tumour, will open in 2022.
The Brain Tumour Charity announced on Thursday 25 November, that the trial has been approved and will begin recruiting over 230 patients at 15 NHS hospitals across the UK in March.
This has seen over £400,000 donated in just three months.
The trial, funded by The Brain Tumour Charity and led by University of Leeds researchers, will now assess whether adding Sativex – an oral spray containing cannabinoids THC and CBD – to chemotherapy could extend life for those living with a recurrent glioblastoma brain tumour.
Sativex, which is already used in treating multiple sclerosis on the NHS, was initially found to be tolerable in combination with chemotherapy with the potential to extend survival in the phase I trial in 27 patients with a glioblastoma earlier this year.
The three-year trial is being led by Professor Susan Short at the University of Leeds and co-ordinated by the Cancer Research UK Clinical Trials Unit at the University of Birmingham,
Experts hope that, should the trial prove successful, Sativex could represent one of the first additions to NHS treatment for glioblastoma patients since temozolomide chemotherapy in 2007.
A major step forward
Dr David Jenkinson, interim CEO at The Brain Tumour Charity, said: “We are delighted to announce that, thanks to the support and generosity of so many in our community, the ARISTOCRAT trial will begin recruitment of patients in March 2022.
“We know there has been significant interest among patients and researchers alike for some time about the potential activity of cannabinoids in treating glioblastomas. We’re really excited that this world-first trial here in the UK could help accelerate these answers and are so grateful to everyone who has donated to help us make this study possible – thank you.”
Glioblastomas are the most common and most aggressive form of brain cancer, with around 2,200 people diagnosed each year in England alone. They are usually fast-growing and diffuse, with poorly-defined boundaries and thread-like tendrils that extend into other parts of the brain.
Almost all glioblastomas recur even after intensive treatment including surgery, radiotherapy and chemotherapy, and average survival is just 12-18 months from first diagnosis.
Dr Jenkinson continued: “The recent early-stage findings were really promising and we now look forward to understanding whether adding Sativex to chemotherapy could help offer life-extension and improved quality of life, which would be a major step forward in our ability to treat this devastating disease.
“In the meantime, while other cannabis-based products may help alleviate symptoms, there is insufficient evidence to recommend their use to help treat brain tumours. For anyone considering using cannabis-based products or other complementary therapies, it’s vital that you discuss these with your medical team first, as they could interact with other treatments such as anti-epileptic medicines or steroids.”
Could Sativex extend life expectancy?
In this new trial, researchers will assess whether adding Sativex to the current standard chemotherapy treatment (temozolomide) could offer extra time to live for adults diagnosed with a recurrence of their glioblastoma after initial treatment.
Participants will be asked to administer up to 12 sprays per day (or to the maximum dose they can tolerate if fewer than 12) of Sativex or placebo oral sprays.
Participants will then undergo regular follow-up including clinical assessment (every four weeks), blood tests, MRI scans (every eight weeks), and they will complete quality of life questionnaires.
The trial will measure whether adding Sativex to chemotherapy extends the overall length of patients’ lives (overall survival), delays the progression of their disease (progression-free survival) or improves quality of life.
Lead investigator Professor Susan Short, commented: “The treatment of glioblastomas remains extremely challenging. Even with surgery, radiotherapy and chemotherapy, nearly all of these brain tumours re-grow within a year, and unfortunately there are very few options for patients once this occurs.
“Cannabinoids have well-described effects in the brain and there has been a lot of interest in their use across different cancers for a long time now. Glioblastoma brain tumours have been shown to have receptors to cannabinoids on their cell surface, and laboratory studies on glioblastoma cells have shown these drugs may slow tumour growth and work particularly well when used with temozolomide.
“It’s really exciting that we’re now at the point where we can run a definitive, well-designed study that will tell us the answer to whether these agents could help treat the most aggressive form of brain tumour. Having recently shown that a specific cannabinoid combination given by oral spray could be safely added to temozolomide chemotherapy, we’re really excited to build on these findings to assess whether this drug could help glioblastoma patients live longer in a major randomised trial.”
How cannabis can offer an alternative for menopause symptoms
Experts at Integro Clinics explore how cannabis medicines can offer an effective alternative to HRT
Experts at Integro Clinics explore how cannabis medicines can offer an effective alternative to HRT treatment for menopause symptom control.
It is now widely accepted that Hormone Replacement Therapy (HRT) can be very useful in treating menopause symptoms. However, it is not suitable for all women – some who may not feel comfortable using it or have a medical contraindication such as a family history of cancer.
There is an alternative out there that can be used in conjunction with HRT treatment, to complement it, or used entirely on its own – cannabis medicines.
At Integro Clinics our female pain expert, Dr Sally Ghazaleh and Neuropsychiatrist, Dr Mayur Bodani have seen encouraging results from patients using medical cannabis in the form of an ingestible oil (CBD mixed with THC) and by vaping prescribed cannabis flower.
The specific symptom cannabis-based medicines (CBM’s) can address in menopause include insomnia, anxiety, depression, headaches, low libido, and brain fog. If you have profoundly disturbed sleep, it can have a massive impact on your quality of life, mental well-being & ability to cope.
At Integro Clinics we have witnessed that once the patient achieves a better and more consistent regular quality of sleep, with the help of CBM’s, everything starts to pick up. Anxiety can decrease, the desire to take physical exercise and mental clarity are increased, which can lead to a lift in depression and a more positive mindset.
If you are interested in finding out in more detail how CBM’s can help you with your menopause symptoms, do not miss the opportunity to register for free for a webinar on Tuesday 30 November. Hosted by Integro Clinics, Cannabis Health and Cannabis Patient Advocacy and Support Services (CPASS), it will look to break down the stigma that women face when it comes to menopause and medical cannabis.
To register for a free ticket for the webinar, please click here
On the panel
Integro Clinics Dr Sally Ghazaleh and Dr Mayur Bodani will join other experts in the field including specialist sexual health nurse Sarah Higgins. There will also be an opportunity to take questions from the audience.
Dr Sally Ghazaleh is a pain management consultant and prescriber of cannabis-based medicines at Integro Clinics, where she is the resident female pain expert. Dr Ghazaleh specialises in managing patients with lower back pain, neck pain, neuropathic pain, abdominal pain, cancer pain, complex regional pain syndrome, post-stroke pain and fibromyalgia. She has a particular interest in bladder and abdominal pain in women, and women’s health in general & menopause. She is fluent in Arabic, English and Hungarian.
Dr Mayur Bodani, a neuropsychiatrist at Integro Clinics qualified in both General Medicine (to hospital medicine standard) and neuropsychiatry. He has over 25 years of experience in the field and prescribes cannabis medicines at Integro Clinics for mental health-related conditions.
Gone are the days where women are just supposed to put up and get on with it – there are new medicines out there such as medical cannabis, that can address and help menopause symptoms.
If you would like further information or to speak to Dr Sally Ghazaleh or Dr Mayur Bodani or any of the team at Integro please contact us at:
Men’s mental health: “It’s something you have to deal with every day”
Ian McLauren and Sam Williamson, co-founders of CBDiablo speak about mental health support and what needs to change for men.
In the final part of our Men’s Mental Health series, Ian McLauren and Sam Williamson, co-founders of CBDiablo speak about how their own experiences and why they choose to give back to a mental health charity.
Ian McLauren and Sam Williamson, co-founded CBDiablo together in 2019, an online, Edinburgh-based CBD store that has a particular focus on mental health.
Both men have experienced mental health difficulties in their lives, which made them feel passionate about offering help to others. So much so that they donate a portion of their profits to mental health charities.
Ian explained how his experience of bullying while at school, started his struggle with mental health.
“My mental health journey started when I was a teenager. I struggled a lot with bullying and I experienced anxiety. When I got a little bit older, this led to suicidal thoughts and I needed to go to counselling,” he said.
A report from 2018, revealed that bullying can have a massive effect on pupils’ mental health. In a survey of 2,000 students, one fifth said they had experienced bullying while three quarters felt this directly impacted their mental health. A further 33 per cent reported having suicidal thoughts as a result.
“When I got to university, I got sick with a reoccurring chest infection which led to [me experiencing] depression and struggling to function,” Ian continued.
“My life is quite heavily impacted with my mental health and even today it’s a struggle. It’s something you have to deal with every day but I’ve gotten to a place where I’m on top of it.”
It can be difficult to open up about mental health, especially for men. They are less likely to access psychological therapies than women, according to The Mental Health Foundation. Only 36 per cent of referrals to the NHS talking therapies are men. As a result, men may resort to other more dangerous ways of coping with mental health strain, such as drinking, drugs or violence.
Mental health and staying CALM
The charity, Campaign Against Living Miserably (CALM) estimates that 125 people die by suicide every week in the UK, with 75 per cent of those deaths being men.
Ian said: “I spoke to my mum and she pushed me in the direction of help. I was very nervous and unsure what to do. When I was at university, it got to a point where I didn’t want to lay around in bed anymore, so I knew I needed to go and get a job and complete my studies. I went to the doctors and got help that way. I don’t remember it being difficult, but it wasn’t my choice either, I was either forced by situation, or by a parent.”
Ian and Sam met in their first year of university. After they completed their studies, they moved into marketing and SEO, but it wasn’t until they worked with a CBD company that they came across its benefits for mental health. They decided to go into business together but were determined to have a charitable focus.
Sam said: “We tried CBD when we started working with the client and we felt a benefit from it fairly early on, especially for things like sleep. Sleep is obviously a big part of your mental health.”
A lack of sleep creates a vicious circle when it comes to health. Poor sleep can impact mental health leaving a person feeling sluggish, stressed or increasingly anxious. Increased stress or anxiety can then affect the quality of sleep contributing to poor mental health.
Ian added: “We really enjoyed CBD, so we thought we would do something by ourselves. But [we wanted to] do something that means something. The obvious choice was mental health because of my own experiences. We made a beeline for CALM as well because it represents who we are.
“I’ve got two brothers and Sam has three brothers. We both have dads or uncles and it’s not always easy to open up, especially for men. That’s why we chose a mental health charity and one with a predominately male focus.”
Mental Health charities
CALM is a charity that takes a stand against suicide in the UK, by raising awareness of the stereotypes, offering help and running life-saving services.
It offers a free and confidential web chat for anyone in need of help and also hosts support services for anyone who has lost someone due to suicide. While the charity is not solely focused on men, it has launched campaigns such as #BestManProject which aims to challenge male stereotypes, encourage positive behavioural changes and address help-seeking behaviour using art, music or sport.
Both Ian and Sam decided to donate 20 per cent of their profits to CALM. They are incredibly transparent about the donation process often posting their donations to the charity on Instagram. In September, they posted that they donated £665. CALM highlighted that just £8 can answer one life-saving call and that they managed to answer over 83 of these over the month of August.
The brand also highlights mental health and wellness across their social media, choosing to focus on Movember for men’s health. Movember is the mental health campaign that sees men grow their facial hair to raise awareness.
The response has been positive. Sam explained it is one of the reasons that people stay with the brand, while they often email to say it has been the start of their own mental health journey.
“It’s a bit part of the reason why people continue to buy from us,” Sam said.
Ian added: “We get a lot of people emailing to say it’s changed their life, which is great, or that it has been a building block towards feeling better. It might have been part of their journey towards therapy or improving their lifestyle. CBD does seem to be quite a fundamental part of it for some people.”
When it comes to changing the way men speak about their mental health, Ian highlighted that it can be a generational thing.
“I think a lot of the time, older generations of men don’t want to seem weak or vulnerable and that’s transcended down to younger generations,” he said.
“Even though things are a little better, there is partly a pride or bravado. If you are struggling with mental health or feeling bad then you’re not really meant to bring it up, so it’s awkward to talk to somebody.”
He continued: “A lot of guys don’t feel equipped to deal with that conversation either. If a friend comes to you who is struggling, then I don’t think a lot of men know how to deal with that. Girls seem to deal with it really well, it seems to be discourse between friends but for men, not so much.”
In speaking with other charities that deal with male mental health or creating communities where men can go to feel less isolated, they have also learned that sometimes it can be down to body language.
Ian added: “Apparently men like to sit next to each other, side by side, but women prefer to be face to face, which is how they like to open up. There are those key differences but it’s not clear if it’s biology that causes that. These are differences that might stop health services from being equipped to deal with different people because there are slight differences in the way people open up.”
Fibromyalgia and medical cannabis: “I find my pain is completely gone”
Natalie began experiencing fibromyalgia pain when she was a teenager but wasn’t diagnosed until her 20s.
Natalie talks to Cannabis Health about living with fibromyalgia and how cannabis has helped her with pain relief.
Fibromyalgia can be a debilitating condition leaving patients with chronic pain, fatigue and increased sensitivity. Other side effects can include poor sleep, cognitive issues and headaches. It is thought to affect around 1.5-2 million people in the UK.
Natalie was diagnosed with fibromyalgia when she was in her first year of teaching. She had been experiencing some of the symptoms since she was in her early teens but doctors told her it was growing pains.
“Since I was about 12, I had a lot of pain that came and went with a lot of fatigue,” she explains.
“The doctor’s put it down to growing pains. When I was I was in my first year of teaching, one day I woke up and couldn’t do anything. I was incredibly tired and in so much pain.
“I felt that way for months and I was really struggling. I got my formal diagnosis from a rheumatologist. I had a lot of blood and strength tests to make sure I didn’t have arthritis or lupus because of the similar symptoms.”
Life with fibromyalgia
Once Natalie had her diagnosis, her life began to change. She quit her teaching job as it became too much to cope with when her symptoms were bad. She took on jobs where she could choose her own hours or work part-time.
“I ended up working as a children’s entertainer because it was good money,” she says.
“I could do it over a few days a week and make an acceptable amount of money to cover my bills. I did retail work alongside it.”
When it came to socialising, to stop herself from feeling isolated, Natalie turned to online communities to meet people and make friends.
“I’m not amazing at socialising, so I’ve always found it a struggle. I didn’t stay in touch with a lot of people from university or school because I also have mental health problems that held me back. This isolated me a lot so I did turn to online communities where I met a few people who I’m still friends with now,” says Natalie.
It wasn’t until she joined online fibromyalgia communities that someone suggested that cannabis may have benefits.
“I never really knew about its benefits, although I knew it would relax you,” she admits.
“People in my fibromyalgia groups said they used medical cannabis and found it helpful. It’s only really been the last few years where I’ve used it properly as a medicine.”
Cannabis may help with the pain experienced by fibromyalgia patients. A recent study on patients diagnosed with fibromyalgia and other inflammatory rheumatic diseases reported a reduction in pain levels following medical cannabis use. The study surveyed 319 patients about their use of medical cannabis products. Those with fibromyalgia reported a mean pain level reduction of 77 per cent while 78 per cent also reported sleep quality improvement.
Although Natalie has family members who use medical cannabis in legal states in the US, she hadn’t considered using it herself. Despite being open to the idea of a prescription, she says there was very little mentioned to her about pursuing it by her doctors.
“It’s weird because it’s almost like a whisper network. I would never have known about the private medical thing because it’s not really mentioned and the health sector doesn’t talk about it. They don’t actively tell you about prescriptions,” she says.
Natalie has found that cannabis helps her most with the pain.
“A lot of the time, I get shoulder or lower back pain. If other people knew my pain level, they would have a different idea of what pain is, but I guess I’m used to it,” she says.
““Due to the way I work, I don’t use it until the evening. At the end of the day, I’ll use cannabis and I find my pain is completely gone. Sometimes, if I’m struggling then I’ll have a nice bath, have my cannabis and that’s the perfect combination.”
Natalie is guarded about her cannabis use because of the stigma but also due to her job. She is open with some of her friends but not her family. She chose to use only her first name to avoid being identified.
“My parents are from a different generation and they are quite conservative too. It’s very different for them so they don’t understand how it would help. My clients obviously don’t know, as some wouldn’t like it. [But] I have clients in the Netherlands who don’t drink but will go for a joint but it’s different for me,” she says.
“People still struggle to admit to taking medication because of the attitude. I’ve tried Tramadol, Xanax and all sorts of things that have more impact on how you feel, physically and mentally compared to cannabis. But that’s acceptable because it’s prescribed by a big pharmaceutical company.”
Natalie feels that there is a lot to be changed in terms of education, so that people know the benefit of cannabis when it comes to conditions like fibromyalgia. She also highlighted that there should be more awareness of the options out there when it comes to accessing a prescription.
“More people should be aware of the benefits of what it can do, rather than it being a niche internet topic or having a weird stigma around it,” she adds.
“Medical professionals need to be more aware of how it can help and the different avenues that people can go down to get prescriptions.”
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