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Patterns of Use of Medical Cannabis Among Israeli Vol. 49 No. 2 February 2015 Journal of Pain and Symptom Management 223 Original Article Patterns of Use of Medical Cannabis Among Israeli Cancer Patients: A Single Institution Experience Barliz Waissengrin, MD, Damien Urban, MD, Yasmin Leshem, MD, Meital Garty, BA, and Ido Wolf, MD Institute of Oncology (B.W., M.G., I.W.), Tel Aviv Sourasky Medical Center, Tel Aviv; Institute of Oncology (D.U., Y.L.), Chaim Sheba Medical Center, Ramat Gan; and Sackler Faculty of Medicine (I.W.), Tel Aviv University, Tel Aviv, Israel Abstract Context. The use of the cannabis plant (Cannabis sativa L.) for the palliative treatment of cancer patients has been legalized in multiple jurisdictions including Israel. Yet, not much is currently known regarding the efficacy and patterns of use of cannabis in this setting. Objectives. To analyze the indications for the administration of cannabis among adult Israeli cancer patients and evaluate its efficacy. Methods. Efficacy and patterns of use of cannabis were evaluated using physician-completed application forms, medical files, and a detailed questionnaire in adult cancer patients treated at a single institution. Results. Of approximately 17,000 cancer patients seen, 279 (<1.7%) received a permit for cannabis from an authorized institutional oncologist. The median age of cannabis users was 60 years (range 19e93 years), 160 (57%) were female, and 234 (84%) had metastatic disease. Of 151 (54%) patients alive at six months, 70 (46%) renewed their cannabis permit. Renewal was more common among younger patients and those with metastatic disease. Of 113 patients alive and using cannabis at one month, 69 (61%) responded to the detailed questionnaire. Improvement in pain, general well-being, appetite, and nausea were reported by 70%, 70%, 60%, and 50%, respectively. Side effects were mild and consisted mostly of fatigue and dizziness. Conclusion. Cannabis use is perceived as highly effective by some patients with advanced cancer and its administration can be regulated, even by local authorities. Additional studies are required to evaluate the efficacy of cannabis as part of the palliative treatment of cancer patients. J Pain Symptom Manage 2015;49:223e230. Ó 2015 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved. Drs. Waissengrin and Urban contributed equally to Accepted for publication: May 28, 2014. this article. Address correspondence to: Ido Wolf, MD, Institute of Oncology, Tel Aviv Medical Center, Tel Aviv 52621, Israel. E-mail: [email protected] Ó 2015 American Academy of Hospice and Palliative 0885-3924/$ - see front matter Medicine. Published by Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jpainsymman.2014.05.018 224 Waissengrin et al. Vol. 49 No. 2 February 2015 Key Words Cannabis, cancer, palliative care, pain, chemotherapy Introduction for any symptom attributed to the disease it- self or to treatment (e.g., pain, CINV, weight An increasing number of countries, loss, depression). Permits were granted including Israel, have legalized the use of the following a formal request by the treating cannabis plant (Cannabis sativa L.) for the oncologist, who was required to specify the treatment of a wide range of cancer-related clinical condition of the patient and the pre- symptoms.1 The cannabis plant contains À cise indications for prescribing cannabis. more than 70 cannabinoids, with D 9-tetrahy- The cannabis was supplied to the patients by drocannabinol (THC), cannabinol, and can- alegaldistributor. nabidiol (CBD) being considered the most We aimed to analyze the indications for the active and clinically relevant.2 These com- administration of cannabis among adult Israeli pounds are primarily found in the dried flow- cancer patients and evaluate the efficacy of ering tops and leaves of the female plant. cannabis both directly, using a detailed question- These dried parts are known as marijuana, naire, and indirectly, by examining the prescrip- and the content of THC in these parts may tion renewal pattern among these patients. exceed 10%.3 The cannabinoids mediate their action through two kinds of G-protein-coupled receptors, CB1 and CB2, found in membranes of nerve cells. The CB1 receptor is found pre- Methods dominantly in the central and peripheral ner- Participants vous systems and suppresses neuronal The Sheba Medical Center is an academic excitability,4 whereas the CB2 receptor is medical center, affiliated with Tel Aviv Univer- found predominantly in immune tissue and sity in Israel, serving as a regional and a tertiary is not related to psychoactive effects.5,6 center for cancer patients. All consecutive Several studies have tested the efficacy of adult patients ($18 years old) who were either synthetic or purified cannabinoids in treated at the Oncology and Gynecology the treatment of cancer-related symptoms. Oncology Departments of Sheba Medical Cen- Thus, synthetic cannabinoids were found to ter and received a permit for medical cannabis reduce chemotherapy-induced nausea and between October 2010 and September 2011 vomiting (CINV) compared with either placebo were included in the study. Symptoms were or older generations of antiemetic medica- managed by the treating oncologist according tions6,7 but did not increase appetite compared to best practice, with a dedicated palliative care with placebo or megestrol.8,9 Two recent Phase team consisting of a trained nurse and physi- III trials noted a modest effect of either THC/ cian being available for consultation. Per na- CBD extract or the synthetic cannabinoid nabi- tional guidelines, all cancer patients receiving lone compared with placebo for the treatment either active oncology treatment or supportive e of intractable cancer-related pain.10 12 To our care, as well as patients receiving adjuvant knowledge, no controlled trials have tested chemotherapy, were eligible for a permit. the efficacy of the cannabis plant in cancer The use of cannabis in the adjuvant setting patients. Despite lack of evidence-based data, was limited, per institutional guidelines, only cannabis use has been legalized in several West- for the treatment of severe side effects ern countries or jurisdictions, including The refractory to conventional treatment. All re- Netherlands13 and the U.S.14 quests for eligible patients by the treating on- In 2010, the Israeli Ministry of Health cologists were approved by the institutional authorized five oncologists to issue permits authorizing oncologist (I. W.). Patients with for cannabis use in oncology patients being hematological malignancies and children treated at their institution. Permits were valid were excluded. The study was approved by for a period of six months and could be issued the local research ethics board. Vol. 49 No. 2 February 2015 Cannabis in Cancer Patients 225 Measures Results Data on demographics, clinical diagnosis, Study Population treatment, and indications for cannabis were During the one year study period, 279 of collected from the permit application forms. approximately 17,000 oncology patients being At the time of the study, permits for cannabis treated or observed at the Sheba Medical Cen- use were valid for six months, and their ter received a permit for medical cannabis. renewal required reapplication by the treating Thus, the estimated percentage of patients oncologists. We used the reapplication forms, who received a permit was 1.7%. The demo- together with survival data obtained from med- graphic and clinical characteristics of all ical charts, to classify patients into three patients who received a permit, as well as those groups: alive and requested permit renewal, who completed the detailed questionnaire, are alive but did not request renewal, and dead. presented in Table 1. The median age of To assess the perceptions of patients patients was 60 years (range 19e93 years); regarding the efficacy of cannabis, a detailed 57% were female; and the most common can- questionnaire was administered at least one cer diagnoses were lung (18%), ovarian month and up to six months after cannabis (12%), breast (10%), colon (9%), and pancre- approval to Hebrew-speaking patients able to atic (7.5%) cancer. The majority of the pa- answer the questionnaire. The questionnaire tients (84%) had metastatic disease. The was completed by the patients during their visit oncology treatment was defined by the refer- to the oncology clinic. We focused only on ring physicians as active palliative in 199 patients who were actively using cannabis. The (71%), supportive care in 36 (13%), and cura- questionnaire was based on the literature, as tive in 17 (6%) patients. In most patients (216; well as previous experience and expert opinion. 77%), cannabis was requested for multiple in- It comprised 39 questions: 15 questions dications. The most common indication for collected demographic and clinical data; 10 which cannabis was prescribed was pain questions about the use of cannabis, including (76%), with anorexia, generalized weakness, the start date, indications, and mode of use; 10 and nausea also being common indications questions about the efficacy of and attitudes to- (56%, 52%, and 41%, respectively). ward cannabis (scored on a five-point Likert scale, with 1 ¼ strongly disagree and 5 ¼ strongly agree); and four questions about Renewal Pattern adverse effects and their severity (scored on a Almost half of the patients (128; 46%) died five-point Likert scale). An improvement in within six months, and 36 (13%) died within symptom control was defined as a 4e5 on the one month of receiving the first cannabis Likert scale, and side effects were categorized permit. Of the remaining 151 patients, 70 as mild (1e3 on the Likert scale) or severe (46%) renewed their permit. The demo- (4e5 on the scale). A pilot study of five medical graphic and disease characteristics of patients personnel and five patients was conducted to who did and did not renew the license are pre- assure proper wording. No external validation sented in Table 2. Renewers were more likely was performed. to be younger (median age 53 vs.
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