Is cbd oil effective for stage 4 pancreatic cancer
Background: Pancreatic cancer ranks among the deadliest solid tumors. When patients complain about symptoms, the tumor has already spread in the majority of cases to neighbouring tissues and organs with limited possibilities for surgical interventions. In a very recent population-based study which included a total of 36,453 patients with pancreatic ductal adenocarcinoma, median overall survival was only 3.8 months. A growing number of articles suggest potential anticancer benefits of cannabinoids, in particular of cannabidiol (CBD). This is the first time that treatment experiences with CBD are described in patients with pancreatic cancer.
Case Series: A total of nine consecutive patients with pancreatic cancer received CBD. All but two received standard chemotherapy in addition, two patients only CBD. CBD was usually administered in an oral daily dose of 400mg. The mean overall survival of these nine patients was 11.5 months (median 11 months).
Conclusion: Overall survival seems to be about two times longer than reported in the population-based study mentioned above.
Cannabidiol, cannabinoids, pancreas adenocarcinoma, pancreatic cancer, survival
Pancreatic cancer is on the rise; it has been predicted that by the year 2017 in the EU more deaths from pancreatic cancer will occur than breast cancer . Pancreatic cancer is one of the deadliest solid tumors with pancreatic ductal adenocarcinoma (PDAC) being the most common form (about 90%), and with the worst prognosis . Ductal adenocarcinoma is preferentially localized to the head of the organ (75%), followed by the body (15-20%) and tail (5-10%) . Pancreatic cancer is rarely diagnosed in time; in 2/3 of the cases, the tumor has already infiltrated adjacent tissues, blood vessels and organs or has formed metastases when patients present with first symptoms. Survival is slightly longer in patients with localised disease, having no metastases, and who received chemo (radio) therapy without resection; resection improves survival further. Optimal treatment typically involves a multimodality approach with surgical resection whenever possible, combined with chemotherapy and radiation. Nonetheless prognosis continues to be generally poor.
In many carcinomas, including pancreas ductal adenocarcinoma (PDAC), the endocannabinoid system seems to be disturbed. Whereas in normal pancreatic tissue cannabinoid receptors CB1 and CB2 are expressed at almost undectable levels, a very high expression of CB1 and low levels of the endocannabinoid degrading enzymes fatty acid amid hydrolase (FAAH) and monoacylglycerol lipase (MAGL) are observed in cancer cells. This disbalance correlates with a shorter survival . Other targets that have been found to be differently expressed compared to normal pancreatic tissue are the orphan cannabinoid receptor GPR55, and the ion channel TRPM8. Both are upregulated in human pancreas adenocarcinoma tissues which correlates with lower overall survival; importantly, CBD acts on both as inhibitor [5, 6]. Pharmacologic inhibition of GPR55 by CBD reduces growth, cell cycle progression, and activation of mitogen-activated protein kinase (MAPK) signalling in pancreatic ductal adenocarcinoma cells, whereas the inhibition of TRPM8 reduces proliferation [5, 7]. Other targets that may play a role in pancreatic cancer are TRPM7, the so called “capsaicin-receptor” TRPV1, and TRPV2; both are activated by CBD which induces pro-apoptotic effects [8-10]. Increased expression of TRPM7 (which regulates tumor cell migration) correlates with poor patient prognosis.
Cannabinoids, including cannabidiol (CBD), have been repeatedly reported to reduce tumor cell growth in vitro and in vivo. In a recent animal study, which used a clinically relevant pancreatic cancer model, CBD improved survival outcomes significantly, and in a similar order as gemcitabine. Even more important, when CBD and gemcitabine were combined, survival was 2.8 times longer than that of controls, and about twice as long with either drug alone . In view of repeatedly described anticancer activities of CBD, and given that CBD is well tolerated, CBD (phyto-cannabidiol, purity at least 99.8%, source: Trigal Pharma GmbH, Wien, Austria) was added as comedication to our patients with pancreatic adenocarcinoma [11-13]. Magisterial CBD capsules or liquids (20% CBD) have been prepared by a local pharmacy. Below we summarise our observations on 9 consecutive cases. The majority of these patients had been seen at other hospitals before presenting in our department.
Female patient diagnosed at 70 years of age. In November 2017, the patient was hospitalised for nausea and vomiting; a gastroenteritis and colitis were diagnosed, and the patient had been dismissed. In January 2018 the patient complained of thoracolumbar pain; ultrasonography showed multiple hypodense foci in pancreas, liver, stomach, kidney, adrenal gland and peritoneum. A biopsy revealed a ductal adenocarcinoma of the pancreas. Chemotherapy with gemzar-abraxane (gemcitabine and paclitaxel attached to human albumin) was started (total of three courses), in parallel with low dose CBD (100 mg/day). The patient passed away 16 weeks after diagnosis and 14 weeks after start of CBD.
Male patient diagnosed at 47 years of age. In April 2018 the patient presented with a sudden pain in the upper abdomen radiating to the back, early fullness after meals, and an uncomfortable swelling in the abdomen. Ultrasonography and CT showed an unresectable 3×3 cm mass in the head of the pancreas with multiple round lesions in the liver and enlarged lymph nodes paravertebral, but no ascites and no lung or bone metastases. A CT-guided biopsy demonstrated the presence of an adenocarcinoma. Chemotherapy with gemzar-abraxane was recommended but denied by the patient. Medication with 2×200 mg CBD/day and low dose delta-9-tetrahydrocannabinol (3×2.5 mg THC/day) was started and continued until the patient passed away 15 months after diagnosis, and 14.5 months after starting the treatment with cannabinoids.
Male patient diagnosed at 47 years of age. The patient had a positive family history as his mother had died from a pancreas carcinoma. The patient suffered from diabetes type II since 2011 and from an adenocarcinoma of the prostate with prostatectomy performed in May 2016 (pT3a, pN1 (1/8), R0; Gleason score 5+3=8) with positive lymph nodes. A PET-CT in June 2016 showed a suspicious lesion (2.9×1.4 cm) on the right adrenal gland. A control (abdominal CT) in September 2016 did not demonstrate any changes. An MRT end of September 2016 however demonstrated an increase of the lesion on the right adrenal gland to 3.6×2.3cm; the lesion was negative in a PSMA-PET examination therefore unlikely of prostate origin. End of November 2016, increased levels of bilirubin and gGT were observed. A cholangiography, PET-CT and MRT were performed and demonstrated a large mass of 4.2×3.2 cm in the head of the pancreas compressing the common hepatic duct as well as increased lymph nodes; a stent was placed in the ductus hepaticus communis.
A pancreas carcinoma was suspected although a biopsy was inconclusive. In December, a 15 mm lymph node near the aorta was excised which did not show malignancy. CBD was started in January 2017 (2×100 mg/day, increased to 2x 200 mg after 3 weeks). A PET-CT in March 2017 showed progressive disease in the head of the pancreas and enlarged para-aortal lymph nodes. In April 2017 an explorative excision of the head of the pancreas was performed and an adenocarcinoma of the pancreato-biliary type was diagnosed (positive for CK7, CK19, negative for CK20, CDX2) as well as metastases in the liver and a peritoneal carcinosis. In June 2017 chemotherapy with gemzar-abraxane was started but stopped after the second course as the patient did not want further chemotherapy. CBD was stopped as well, 13 weeks after the first administration. The patient passed away in September 2017, 11 months after the detection of a suspicious lesion in the pancreas.
Female patient diagnosed at 67 years of age. The patient had a history of breast cancer operated on in 1997 and subsequent radio chemotherapy. A second surgical intervention was performed in 2009 followed by three courses of fluorouracil, epirubicin and cyclophosphamide, as well as three courses of taxotere. Beginning in August 2016, radiological examinations (MRT, PET-CT) demonstrated a lesion in the head of the pancreas, suspicious for a carcinoma but unresectable, with no enlarged lymph nodes. An explorative laparoscopy and cholecystectomy (histology negative) in August 2016 confirmed inoperability. In September 2016, an Endoscopic Retrograde Cholangiopancreatography (ERCP) was performed, and a stent was placed in the ductus hepaticus communis.
Chemotherapy with gemzar-abraxane was started in September, including also concomitant THC to improve appetite (3×2.5 mg/day). Both were stopped one month later. A MRT control in February 2017 revealed an increase of the tumor in the head of the pancreas, and in the processus uncinatus as well as metastases in the lung, diaphragm and ascites; CBD (2×200 mg/day) was started mid of March and maintained until the patient passed away mid of April 2017, 8 months after diagnosis.
Male patient diagnosed at 70 years of age. The patient had a history of COPD, hypertension and hyperuricaemia. In March 2017, a routine laboratory control showed increased bilirubin and a very high level of CA 19-9 (74,800 U/L). In the following, an unresectable, very advanced adenocarcinoma of the pancreas was diagnosed with multiple metastases in the liver. CBD (2×100 mg/day) and monotherapy with gemcitabine was started but stopped after 2 weeks because of fresh ischaemic lesions in the brain. CBD was maintained until the patient passed away 8 weeks after diagnosis.
Female patient diagnosed at 68 years of age. The patient had suffered since more than two months of increasing, pronounced dyspnoea before admission to the hospital in January 2015. A CT of the lung showed multiple, small, round lesions in both lungs and a suspicious lesion in the pancreas. In addition, increased levels of CEA and CA 19-9 were found. A biopsy of the pancreas demonstrated the presence of an invasively growing, unresectable adenocarcinoma in the body of the pancreas. The resection of one lesion in the lung confirmed metastasis of the pancreas adenocarcinoma. In the following, the patient was lost of sights for 2 years. According to the patient she received during this time one course of chemotherapy abroad (no details available) but had refused further treatments. In January 2017, radiological assessments demonstrated metastases in almost all vertebrae as well as metastases in muscles. In March 2017 the lesion of the pancreas had increased to 6×4 cm, and secondary lesions were found in muscles (greatest lesion 5x2x4 cm). A metastatic lesion with expansion of the thoracic vertebra #7 received palliative irradiation. Low dose THC (3×1.6 mg/day) was prescribed against kachexia and nausea; in addition, CBD (2×200 mg/day) was started beginning in April 2017 and maintained until the patient passed away 28 months after diagnosis.
Female patient diagnosed at 53 years of age. Beginning of June 2017 an invasively growing, unresectable adenocarcinoma in the body of the pancreas was diagnosed, with multiple metastases in the liver. The patient started the same month with one cycle of chemotherapy with abraxane, followed by one cycle of irinotecan-calcium folinate, 5-fluoruracil (5-FU). CBD (2×200 mg/day) was started in parallel to the chemotherapy mid of June. In July, an increase of the body weight and improvement of pain under comedication with CBD was reported by the patient. A CT in October 2017 showed however progressive disease and further treatment including CBD was stopped. The patient died in January 2018, 7 months after diagnosis.
Male patient diagnosed at 45 years of age. The patient had a more than 10-years long history of muscular-skeletal pain caused by tendopathia, multiple luxations of both shoulder-joints, lesion of the labrum and use of a number of analgesics. End of January 2017 he complained of abdominal pain, fatigue, loss of appetite and loss of weight and was hospitalised. Examinations with ultrasound and CT demonstrated multiple round lesions in the liver, up to a diameter of 1.9 cm, an unresectable lesion with a diameter of 3.5 cm in the tail of the pancreas and lesions in the spleen. Treatment with CBD (2×200 mg/day) was started in March and increased in April to 2×300 mg and further to 2×400 mg/day. In May 2017, low dose THC (3×2.5 mg/day) was added to his regimen for one month in order to improve his appetite and mood. From June 2017 onwards he received 400 mg CBD per day until April 2018. The patient died end of July 2018, 18 months after diagnosis.
Female patient diagnosed at 50 years of age. The history the patient revealed nicotine abuse, hyperlipidemia, hypertension, antrum-gastritis and coronary heart disease (with two arterial coronary bypass grafts in 2011). The patient presented early in August 2016 with abdominal pain and cramps. At first glance a pancreatitis was suspected. A laboratory control showed an elevated level of CA19-9 (232 U/l) and a CT demonstrated a lesion of 3×2.5 cm in the area of the processus uncinatus of the pancreas, and a dammed ductus pancreaticus. Pre-operative examinations suggested an advanced but potentially resectable tumor. In September a partial pancreatoduodenectomy (Kausch-Whipple procedure) was performed (tumor staging: pT3N2R0). Chemotherapy with gemcitabine was started in October 2016 together with low dose THC (3×1.6 mg/day). In February 2017, THC was replaced by CBD (started with 2x100mg, increased to 2×200 mg per day in April 2017). Mid of May 2017 chemotherapy was stopped after 6 cycles of gemcitabine and only best supportive care as well as CBD (2×200 mg/day) was further maintained. The patient passed away end of July 2017, 11.5 months after diagnosis.
Patients in this case series had been referred to our department relatively late when they had already advanced, metastatic disease; this explains the delay for starting concomitant treatment with CBD in most cases. Despite that, mean overall survival in this case series was still 11.5 months (median 11 months); during roughly half of this period patients received also CBD (mean treatment duration 5.2 months). Four patients received also low dose delta 9-tetrahydrocannabinol (THC) for a limited time to improve appetite. According to a very recent population-based Dutch study which included a total of 36,453 patients with PDAC, median overall survival, defined as the time between date of diagnosis and date of death, was 11 months in patients with localised compared to 5.9 months in patients with metastatic disease. Overall survival for the entire cohort that included extended disease/growth outside of the pancreas as well as patients with unknown tumor stage was even shorter, only 3.8 months in the period of 2013-2016 .
Notwithstanding that numerous publications on in vitro anticancer effects of cannabinoids exist and very promising effects of cannabinoids, particularly of CBD, have been described in various animal tumor models, clinical studies in cancer patients are still very limited. To the best of our knowledge, this is the first observation on a possible, favourable effect of CBD on the survival of patients with pancreatic cancer. Although it is not possible to predict an individual outcome, patients in our case series seem to survive about 1.9 times longer (median 11 months) compared to patients with metastatic disease in the Dutch study (5.9 months).
In summary, survival of patients in this case series compares favourably with above mentioned population-based data, particularly when considering that two patients (#2 and #8) did not receive chemo or radiotherapy. Intriguingly, the two patients with the shortest survival (#1 and #5) were those who received less than 400 mg CBD per day. Whether a longer/earlier start of treatment and a higher dose and/or other combinations would improve survival is currently unknown and needs further, systematic studies.
Statement of Ethics
Treatment with CBD was approved by the local ethics committee; all patients had consented.
Cannabis, CBD oil and cancer
Cannabis is a plant and a class B drug. It affects people differently. It can make you feel relaxed and chilled but it can also make you feel sick, affect your memory and make you feel lethargic. CBD oil is a chemical found in cannabis.
- Cannabis has been used for centuries recreationally and as a medicine.
- It is illegal to possess or supply cannabis as it is a class B drug.
- Research is looking at the substances in cannabis to see if it might help treat cancer.
- There are anti sickness medicines that contain man-made substances of cannabis.
What are cannabis and cannabinoids?
Cannabis is a plant. It is known by many names including marijuana, weed, hemp, grass, pot, dope, ganja and hash.
The plant produces a resin that contains a number of substances or chemicals. These are called cannabinoids. Cannabinoids can have medicinal effects on the body.
The main cannabinoids are:
- Delta-9-tetrahydrocannabinol (THC)
- Cannabidiol (CBD)
THC is a psychoactive substance that can create a ‘high’ feeling. It can affect how your brain works, changing your mood and how you feel.
CBD is a cannabinoid that may relieve pain, lower inflammation and decrease anxiety without the psychoactive ‘high’ effect of THC.
Different types of cannabis have differing amounts of these and other chemicals in them. This means they can have different effects on the body.
Cannabis is a class B drug in the UK. This means that it is illegal to have it, sell it or buy it.
CBD oil, cannabis oil and hemp oil
There are different types of oil made from parts of the cannabis plant. Some are sold legally in health food stores as a food supplement. Other types of oil are illegal.
CBD oil comes from the flowers of the cannabis plant and does not contain the psychoactive substance THC. It can be sold in the UK as a food supplement but not as a medicine. There is no evidence to support its use as a medicine.
Cannabis oil comes from the flowers, leaves and stalks of the cannabis plant. Cannabis oil often contains high levels of the psychoactive ingredient THC. Cannabis oil is illegal in the UK.
Hemp oil comes from the seeds of a type of cannabis plant that doesn’t contain the main psychoactive ingredient THC. Hemp seed oil is used for various purposes including as a protein supplement for food, a wood varnish and an ingredient in soaps.
Why people with cancer use it
Cannabis has been used medicinally and recreationally for hundreds of years.
There has been a lot of interest into whether cannabinoids might be useful as a cancer treatment. The scientific research done so far has been laboratory research, with mixed results, so we do not know if cannabinoids can treat cancer in people.
Results have shown that different cannabinoids can:
- cause cell death
- block cell growth
- stop the development of blood vessels – needed for tumours to grow
- reduce inflammation
- reduce the ability of cancers to spread
Scientists also discovered that cannabinoids can:
- sometimes encourage cancer cells to grow
- cause damage to blood vessels
Cannabinoids have helped with sickness and pain in some people.
This means a cannabis based product used to relieve symptoms.
Some cannabis based products are available on prescription as medicinal cannabis. The following medicines are sometimes prescribed to help relieve symptoms.
Nabilone is a drug developed from cannabis. It is licensed for treating severe sickness from chemotherapy that is not controlled by other anti sickness drugs. It is a capsule that you swallow whole.
Sativex is a cannabis-based medicine. It is licensed in the UK for people with Multiple Sclerosis muscle spasticity that hasn’t improved with other treatments. Sativex is a liquid that you spray into your mouth.
Researchers are looking into Sativex as a treatment for cancer related symptoms and for certain types of cancer.
How you have it
Cannabis products can be smoked, vaporized, ingested (eating or drinking), absorbed through the skin (in a patch) or as a cream or spray.
CBD oil comes as a liquid or in capsules.
Prescription drugs such as Nabilone can cause side effects. This can include:
- increased heart rate
- blood pressure problems
- mood changes
- memory problems
Cannabis that contains high levels of THC can cause panic attacks, hallucinations and paranoia.
There are also many cannabis based products available online without a prescription. The quality of these products can vary. It is impossible to know what substances they might contain. They could potentially be harmful to your health and may be illegal.
Research into cannabinoids and cancer
We need more research to know if cannabis or the chemicals in it can treat cancer.
Clinical trials need to be done in large numbers where some patients have the drug and some don’t. Then you can compare how well the treatment works.
Many of the studies done so far have been small and in the laboratory. There have been a few studies involving people with cancer.
Sativex and temozolomide for a brain tumour (glioblastoma) that has come back
In 2021, scientists reported the final results of a phase 1 study to treat people with recurrent glioblastoma (a type of brain tumour that has come back). The study looked at Sativex in combination with the chemotherapy drug temozolomide.
Researchers found that adding Sativex caused side effects, which included, vomiting, dizziness, fatigue, nausea and headache but patients found the side effects manageable.
They also observed that 83 out of 100 people (83%) were alive after one year using Sativex, compared to 44 out of 100 people (44%) taking the placebo.
However, this phase 1 study only involved 27 patients, which was too small to learn about any potential benefits of Sativex. The study wanted to find out if Sativex and temozolomide was safe to take by patients.
Researchers have now started a larger phase 2 trial called ARISTOCRAT, to find out if this treatment is effective and who might benefit from it. Speak to your specialist if you want to take part in a clinical trial.
Sativex and cancer pain
There are trials looking at whether Sativex can help with cancer pain that has not responded to other painkillers.
The results of one trial showed that Sativex did not improve pain levels. You can read the results of the trial on our clinical trials website.
Cancer and nausea and vomiting
A cannabis based medicine, Nabilone, is a treatment for nausea and vomiting.
A Cochrane review in 2015 looked at all the research available looking into cannabis based medicine as a treatment for nausea and sickness in people having chemotherapy for cancer. It reported that many of the studies were too small or not well run to be able to say how well these medicines work. They say that they may be useful if all other medicines are not working.
A drug called dexanabinol which is a man made form of a chemical similar to that found in cannabis has been trialled in a phase 1 trial. This is an early trial that tries to work out whether or not the drug works in humans, what the correct dose is and what the side effects might be. The results are not available yet. You can read about the trial on our clinical trials database.
Word of caution
Cannabis is a class B drug and illegal in the UK.
There are internet scams where people offer to sell cannabis preparations to people with cancer. There is no knowing what the ingredients are in these products and they could harm your health.
Some of these scammers trick cancer patients into buying ‘cannabis oil’ which they then never receive.
You could talk with your cancer specialist about the possibility of joining a clinical trial. Trials can give access to new drugs in a safe and monitored environment.
The science blog on our website has more information about cannabis and cancer.
The Effect of Cannabis in Pancreatic Cancer
The prevalence of malnutrition is overwhelming in pancreatic cancer patients, >80% experience a weight loss >10% of their habitual weight, which may develop into cancer cachexia. Cachexia may cause decreased quality of life, increased mortality and morbidity e.g. poorer response to antitumor treatment, longer length of stay, higher complications rate and shorter life expectancy. There is currently no effective treatment of cancer cachexia, but clinical research in medical cannabis show promising results. The cannabinoids THC and CBD show the highest pharmacological effect, but cannabis consists of >70 cannabinoids. THC and CBD exert their effect on the endocannabinoid system which modulate physiological systems such as pain, inflammation, appetite and energy balance. Thus, this potential orexigenic effect from THC and CBD may improve the nutritional state in patients with pancreatic cancer. Taking the above scientific rationale and the lack of evidence into account, the relevance of this clinical trial appears high.
This clinical trial is an eight-week crossover design examining the effects of the cannabinoids THC and CBD on energy- and protein intake and lean body mass as a measure of appetite, nausea and quality of life. A characterization of the metabolism is analysed through a metabolomics analysis.
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms Pancreatic Cachexia; Cancer Cannabis Appetite Loss Palliative Medicine Morbidity Mortality||Drug: THC and CBD Mixture||Phase 2|
The aim is to investigate the effect of the cannabinoids THC (tetrahydrocannabinol) and CBD (cannabidiol) on energy- and protein intake and lean body mass in patients with pancreatic cancer. A metabolomics analysis is conducted to determine the simultaneous and quantitative intracellular metabolites when medical cannabis is administered in patients with pancreatic cancer.
The clinical trial is designed as a crossover intervention trial with a four week intervention period and a four week control period. The study subjects are instructed to administer individual titered doses of medical cannabis during the intervention period. Dietary history, height, weight, bio- impedance, VAS scales and quality of life measurements are conducted at baseline, every second week and at the end of the clinical trial. Six study subjects are invited to a semi-structured interview. Blood samples and urine samples are used for the metabolomics analysis thus a research biobank is established.
Study population: 32 study subjects diagnosed with pancreatic cancer in palliative care are included. Inclusions criteria: adult, weight loss > 5% of habitual weight. Able to understand and read Danish. Exclusion criteria: regular use of cannabis, psychiatric disorders e.g. Anorexia Nervosa, alcohol abuse, life expectancy
Descriptive statistics is used to characterize the study population. The statistical analysis is carried out in R-Project and all primary data are analyzed as intention-to-treat. P value 90% of patients with pancreatic cancer in the palliative phase experience reduced energy- and protein intake. The quantity of the reduction is, however, very poorly described and appear to depend on cancer progression.
The trial which is approved by the Research Ethics Committee is expected to commence May 2017 after approval by the Danish Medicines Agency and the Data Protection Agency. The clinical trial finish no later than February the 6th 2018. The specified time limit is due to the trial is also basis for a master’s thesis in Clinical Nutrition at the Department of Nutrition, Exercise and Sports, University of Copenhagen. A PhD based on this master thesis will proceed afterwards. Taking into account the patients’ usual control times and to minimize dropout, patient inclusion takes place ongoing, so that there is a control- and intervention period at the same time. Outcome measurements including anthropometry and dietary interviews are carried out at baseline, every two weeks and at the termination of each period. Quality of life measurements and VAS scales are filled out weekly in both periods. The semi-structured interview is carried out at the end of the clinical trial.
The results are going to be published, this applies to both positive, inconclusive and negative results. The clinical trial is registered in the two trial databases ClinicalTrials.gov and EudraCT (clinicaltrialsregister.eu). Scientific articles based on the findings are submitted to relevant journals such as The American Journal of Clinical Nutrition (2014 Impact Factor: 6.770). The results are furthermore used in a master’s thesis in Clinical Nutrition at the Department of Nutrition, Exercise and Sports, University of Copenhagen by Ninette Renee Jensen and Rikke Lundsgaard Nielsen. The results will be presented at congresses. reported in scientific articles, in the master”s thesis, in the information material, on the department’s website, at the public master ́s thesis defense as well as at future congresses, or wherever desired. When the clinical trial is completed a report is sent to relevant authorities including the Research Ethics Committee and the Danish Medicines Agency within 90 days of completion.
Necessary permits from the Data Protection Agency, the Danish Medicines Agency and the Research Ethics Committee are obtained before the initiation of the clinical trial. The protocol is approved by the Research Ethics Committee. Side effects caused by medical cannabis varies in the literature, thus an individual titration period is implemented. No fatal cases have been reported with the use of medical cannabis in human clinical trials. Potential beneficial effects are expected when the study subjects are being treated with medical cannabis, since a gain in appetite and quality of life is expected through a modulation in the endocannabinoid system. Patients are informed that the drug is discontinued after the intervention period. The two master’s thesis students review patient charts weekly to evaluate potential side effects to the drug. The clinical trial is terminated immediately in case of serious side effects. Relevant information material is handed out to the study subjects.
Upon loss of muscle mass and function as seen in cancer cachexia, the administration of individually titrated doses of medical cannabis could hypothetically slow down the condition further, by affecting any negative protein – and energy balance through the endocannabinoid system. When relieving cancer cachexia and improving steady-state, we expect improved prognosis’s for the included patients
The overall objective of the study is that it must be orientated towards clinical significance, so that it can be implemented in clinical practice, thus benefit patients with cancer. The short-term goal is that the patients in this trial experience positive effects in terms of increased appetite and quality of life. Positive effects may contribute to increased research into this area thus resulting in improved evidence. In the longer term, the aim is that the results from this study may contribute to a treatment protocol on malnutrition recommending the use of medical cannabis based on high scientific evidence, so a larger group of patients with cancer may benefit. The results from the study may be used for recommendations on doses, side effects and likely beneficial effects when administer medical cannabis. The metabolomics analysis can contribute to a improved understanding of the cancer cachexia pathophysiology and management in a more experimental matter.