These symptoms are some of the most fundamental causes of suffering and disability for oncology patients while undergoing therapies, and some may even lead to worse prognosis.
Traditionally, cancer-related pain is mainly treated by opioid analgesics but a promising substitute for opioid-based medication is Medical Cannabis (MC) and Cannabinoid treatment for cancer-related pain is generally recognized as safe!
Despite the fact that there is a knowledge gap in the study of Cannabis, especially for treating cancer-related pain, a 2020 study showed that most cancer patients requested MC treatment from their oncologist.
The Adverse Effects (AEs) from cannabinoids for cancer treatment are generally well tolerated by the patients and categorized as mild to moderate and the most frequent AEs are memory impairment, drowsiness, nausea, vomiting and xerostomia (dry mouth).
Traditionally, cancer-related pain is mainly treated by opioid analgesics but a promising substitute for opioid-based medication is Medical Cannabis (MC) and Cannabinoid treatment for cancer-related pain is generally recognized as safe!
Despite the fact that there is a knowledge gap in the study of Cannabis, especially for treating cancer-related pain, a 2020 study showed that most cancer patients requested MC treatment from their oncologist.
The Adverse Effects (AEs) from cannabinoids for cancer treatment are generally well tolerated by the patients and categorized as mild to moderate and the most frequent AEs are memory impairment, drowsiness, nausea, vomiting and xerostomia (dry mouth).
The Study...
This long-term study was conducted between January 2019 and September 2021 in Israel and pulished in Frontiers in Pain Research on 20 May 2022.
The institutional Ethics Committee of Haemek Medical Center and Galil Medical Center also approved the study.
Researchers conducted a multi-center, prospective, 6-month longitudinal study that followed up on the effectiveness and safety parameters of MC treatment for cancer-associated symptoms.
Patients were instructed to complete study questionnaires at 4 different periods, up to a few days before MC treatment initiation(T0), and at three more follow-up times: one (T1), three (T3), and six months (T6) following treatment initiation.
Oncologist reported information included cancer diagnosis, classification of malignant tumors (TNM), cancer treatment protocol and the Eastern Cooperative Oncology Group (ECOG) Performance Status score.
Patients reported information included demographics, analgesics consumption and MC treatment characteristics.
The oncologist prescribes the MC dose (grams per month), the cannabidiol (CBD) and (-)-Δ9-tetrahydrocannabinol (THC) concentrations, based on the Israel Ministry of Health (IMOH) guidelines.The initial dose is 20 gr/month regardless of the route of administration.
404 patients enrolled in the study following the acceptance of an MC license and obtaining pharmacy prescriptions. Of those, 80 (20%) were not eligible for further analyses. Of the remaining 324 patients that initiated MC treatment and completed the baseline (T0) questionnaires, follow-up questionnaires were completed by 212 at T1, 158 at T3, and 126 patients at T6 period.
-Baseline Demographics and Cancer Characteristics...
Patients were on average 64 years old and the majority were females (59%) and previous exposure to cannabis was reported only by 20%.
Oncology diagnoses were diverse, with breast cancer (27%), colon(10%), lung(11%) and ovarian cancers(7%).
Most patients (48%) were categorized as stage IV cancer and chemotherapy was the most prevalent current treatment protocol (55%).
-MC Treatment Characteristics...
Most MC treatment measures did not differ significantly during the six-month treatment. At the endpoint, MC oil extract was the most common route of administration (41%)
Althought CBD monthly doses did not change significantly during the study, THC-rich cultivars were consumed more frequently, with monthly doses of THC increasing from 2,000mg at period T1 to 3,000mg at the endpoint.
-Pain Measures...
Patients were instructed to complete study questionnaires at 4 different periods, up to a few days before MC treatment initiation(T0), and at three more follow-up times: one (T1), three (T3), and six months (T6) following treatment initiation.
Oncologist reported information included cancer diagnosis, classification of malignant tumors (TNM), cancer treatment protocol and the Eastern Cooperative Oncology Group (ECOG) Performance Status score.
Patients reported information included demographics, analgesics consumption and MC treatment characteristics.
The oncologist prescribes the MC dose (grams per month), the cannabidiol (CBD) and (-)-Δ9-tetrahydrocannabinol (THC) concentrations, based on the Israel Ministry of Health (IMOH) guidelines.The initial dose is 20 gr/month regardless of the route of administration.
404 patients enrolled in the study following the acceptance of an MC license and obtaining pharmacy prescriptions. Of those, 80 (20%) were not eligible for further analyses. Of the remaining 324 patients that initiated MC treatment and completed the baseline (T0) questionnaires, follow-up questionnaires were completed by 212 at T1, 158 at T3, and 126 patients at T6 period.
-Baseline Demographics and Cancer Characteristics...
Patients were on average 64 years old and the majority were females (59%) and previous exposure to cannabis was reported only by 20%.
Oncology diagnoses were diverse, with breast cancer (27%), colon(10%), lung(11%) and ovarian cancers(7%).
Most patients (48%) were categorized as stage IV cancer and chemotherapy was the most prevalent current treatment protocol (55%).
-MC Treatment Characteristics...
Most MC treatment measures did not differ significantly during the six-month treatment. At the endpoint, MC oil extract was the most common route of administration (41%)
Althought CBD monthly doses did not change significantly during the study, THC-rich cultivars were consumed more frequently, with monthly doses of THC increasing from 2,000mg at period T1 to 3,000mg at the endpoint.
-Pain Measures...
Patients have been suffering from pain for 4 months at first period T0. All pain measures improved from T0 at all the follow–up time periods.
Mentionable are the significant changes between T0 and T6 periods, for patients that reached the endpoint the average weekly pain intensity reduced by 20%, least pain intensity declined by 25% and worst pain by 20%.
The full spectrum of responses, for all pain measures, in patients reporting was positive in pain decrease, no change or negative in pain increase responses at each time point are indicated.
While most patients reported some degree of pain intensities decrease, about 20% of patients reported either no change in their pain intensity from baseline or on pain intensity increase. Notably, 33% of the patients reported on average pain intensity and total reduction at T6, respectively.
-Analgesics Consumption...
Of the patients that reported fully on their analgesic medications consumption at T0 and T6, 40% of those who had been using analgesic medications at T0, were no longer using them at T6
Conversely, 10 patients (20%) initiated analgesic medications at T6 while not
consuming any at T0.
Specifically, patients that reached the T6 consumed opioids at T0.
-Cancer Symptom Burden...
The study's primary outcome measure, the cancer symptom burden, decreased significantly from T0 to T6. Cancer symptom burden decreased by 18% and the worsening from 122 to 89 patients.
The patients reported positive change and no change or negative change at each time point.
Most patients (about 60%) reported a positive effect.
-Cancer Related Symptoms...
Significant decrease was found in anxiety levels, which decreased by 22% at T6.
-Depression also decreased by 12% at T6.
-Pain scores reduced by 18% at T6.
-Sleep disturbance scores decreased by 16% and showed only positive changes.
-Finally, the quality–of–life score improved significantly from T0 to T6 by 14%.
Notably, most patients (about 60%) reported a positive effect.
-Sexuality Problems...
As described in the methods section, sexuality problems were assessed with specific and different validated questionnaires for females and males. After adjusting for the higher proportion of females in the sample, the response rate to the sexuality questionnaires between the genders was similar. Notably, the response rate to these questionnaires was very low (12–17%).
Researchers found that males mainly reported on absolute improvement in their sexuality problems following MC treatment, with scores increased by 6% on the contrary, females reported mainly on absolute worsening in their sexuality problems following MC treatment, with scores reduced by 2%.
Nonetheless, these changes during treatment were not significant for both sexes.
-Medical Cannabis Treatment Safety...
Overall, researchers found 20%-30% of patients reported on AEs with no significant change across treatment duration, from T1 to T6 period. These AEs were mainly non-serious according to FDA definition and did not cause MC treatment discontinuation.
A total of 36 (11%) patients discontinued MC treatment due to MC-related AEs.The specifics of the AEs were unknown for eight of them (n=8), the remainder were fatigue (n=5), dizziness (n=4), hallucinations (n=4), bad taste (n=3), drowsiness (n=2), and abdominal pain, anxiety, cough, fainting, heat waves, hypotension, nausea, palpitations, restlessness and shortness of breath (one each time).
-Discussion & Conclusion...
There is a growing interest in studies on the effectiveness of an MC treatment for oncology patients.
The main finding of the current study is that most cancer related symptoms improved significantly during the 6 months months of MC treatment.
MC treatment in cancer patients was well tolerated and safe.
In the current study, almost half of the patients stopped all analgesic medications following 6 months of MC treatment. One explanation for this could be that MC constituted a substitution analgesic.
Indeed, previous prospective studies have demonstrated similar findings in chronic non-cancer pain patients, and in a survey of gynecologic cancer patients, almost half reported that they decreased opioids following MC medication.
In the extended period of 6 months (T6), there were mostly non-serious AEs with no significant change from those at the one-month checkpoint, the most frequent being dizziness and tiredness.
This finding aligns with previous studies, suggesting these AEs can be attributed to the MC treatment and not to the disease itself.
In conclusion, this large-scale study demonstrated an overall mild to modest long-term statistical improvement of all investigated measures including pain, associated symptoms and, importantly, reduction in opioid (and other analgesics) use.
It seems that MC treatment is safe for oncology patients, but its efficacy and clinical relevance may be limited. Oncologists should carefully consider the possible benefits of MC treatment to their patients before prescribing it.
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