scholarly journals Methylphenidate and/or a Nursing Telephone Intervention for Fatigue in Patients With Advanced Cancer: A Randomized, Placebo-Controlled, Phase II Trial

2013 ◽  
Vol 31 (19) ◽  
pp. 2421-2427 ◽  
Author(s):  
Eduardo Bruera ◽  
Sriram Yennurajalingam ◽  
J. Lynn Palmer ◽  
Pedro E. Perez-Cruz ◽  
Susan Frisbee-Hume ◽  
...  
Keyword(s):  
Advanced Cancer ◽  
Symptom Assessment ◽  
Well Being ◽  
Primary Objective ◽  
Median Score ◽  
Telephone Intervention ◽  
Fatigue Score ◽  
Cancer Related Fatigue ◽  
Edmonton Symptom Assessment Scale ◽  
Symptom Assessment Scale

Purpose Cancer-related-fatigue (CRF) is common in advanced cancer. The primary objective of the study was to compare the effects of methylphenidate (MP) with those of placebo (PL) on CRF as measured using the Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F) fatigue subscale. The effect of a combined intervention including MP plus a nursing telephone intervention (NTI) was also assessed. Patients and Methods Patients with advanced cancer with a fatigue score of ≥ 4 out of 10 on the Edmonton Symptom Assessment Scale (ESAS) were randomly assigned to one of the following four groups: MP+NTI, PL+NTI, MP + control telephone intervention (CTI), and PL+CTI. Methylphenidate dose was 5 mg every 2 hours as needed up to 20 mg per day. The primary end point was the median difference in FACIT-F fatigue at day 15. Secondary outcomes included anxiety, depression, and sleep. Results One hundred forty-one patients were evaluable. Median FACIT-F fatigue scores improved from baseline to day 15 in all groups: MP+NTI (median score, 4.5; P = .005), PL+NTI (median score, 8.0; P < .001), MP+CTI (median score, 7.0; P = .004), and PL+CTI (median score, 5.0; P = .03). However, there were no significant differences in the median improvement in FACIT-F fatigue between the MP and PL groups (5.5 v 6.0, respectively; P = .69) and among all four groups (P = .16). Fatigue (P < .001), nausea (P = .01), depression (P = .02), anxiety (P = .01), drowsiness (P < .001), appetite (P = .009), sleep (P < .001), and feeling of well-being (P < .001), as measured by the ESAS, significantly improved in patients who received NTI. Grade ≥ 3 adverse events did not differ between MP and PL (40 of 93 patients v 29 of 97 patients, respectively; P = .06). Conclusion MP and NTI alone or combined were not superior to placebo in improving CRF.

Dexamethasone (DM) for cancer-related fatigue: A double-blinded, randomized, placebo-controlled trial.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 9002-9002 ◽  
Author(s):  
Sriram Yennurajalingam ◽  
Susan Frisbee-Hume ◽  
Marvin Omar Delgado-Guay ◽  
Janet Bull ◽  
Alexandria T. Phan ◽  
...  
Keyword(s):  
Advanced Cancer ◽  
Controlled Trial ◽  
Symptom Assessment ◽  
Primary Objective ◽  
Controlled Study ◽  
Advanced Cancer Patients ◽  
Double Blind ◽  
Cancer Related Fatigue ◽  
Significant Difference ◽  
Edmonton Symptom Assessment Scale

9002 Background: Cancer-related-fatigue (CRF) is the most common and distressing symptoms in patients with advanced cancer. Currently, there is no standard treatment for CRF. Although corticosteroids have been used in the treatment of CRF, there are no well-powered placebo-controlled trials that used a validated CRF outcome measure. The primary objective of this prospective, randomized, double-blind, placebo-controlled study is to compare the effect of DM versus placebo on CRF. Methods: Advanced cancer patients with fatigue ≥ 4/10 on the Edmonton Symptom Assessment Scale (ESAS) and at least 2 other CRF-related symptoms (pain, nausea, appetite, depression, anxiety or sleep disturbance ≥ 4/10), normal cognition, no infections and hemoglobin ≥ 9 g/L were eligible for enrollment. Patients were randomized to either receive dexamethasone 4 mg orally twice a day for 15 days (primary end point) or matching placebo. The primary outcome was the day 15 change in Functional Assessment of Chronic Illness-Fatigue (FACIT-F) subscale scores. Differences in the group means (normal distribution) were analyzed using the two-sample t-test. Results: In 83 evaluable patients (43 DM and 40 placebo), median age was 60 years, 61% were white, and 53% were female. There was no difference in the demographics and fatigue (FACIT-F subscale) between DM and placebo groups except for sex (p=0.02). The mean (SD) FACIT-F subscores at baseline and at day 15 for DM were 18 (11) and 27 (11) (p<0.001) and for placebo were 21 (9) and 24 (12) (p=0.06), respectively. Mean improvement in FACIT-F subscale was significantly higher in the DM group compared to placebo (9.6 (11) vs. 3.1 (9.7), p=0.005). We found a significant difference in ESAS physical distress (p=0.02), but no differences in ESAS overall symptom distress (p=0.11) and ESAS psychological distress (P=0.88) between DM and placebo. There were insignificantly higher numbers of grade ≥3 toxicities in patients who received DM than in patients who received placebo (20/42 vs. 18/47, p=0.37). Conclusions: Dexamethasone was more effective than placebo in reducing CRF in patients with advanced cancer. Long-term safety studies are needed.

scholarly journals Patients with advanced cancer and depression report a significantly higher symptom burden than non-depressed patients

2018 ◽  
Vol 17 (2) ◽  
pp. 143-149 ◽  
Author(s):  
Kjersti Støen Grotmol ◽  
Hanne C. Lie ◽  
Jon Håvard Loge ◽  
Nina Aass ◽  
Dagny Faksvåg Haugen ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Advanced Cancer ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Symptom Burden ◽  
Symptom Assessment ◽  
Well Being ◽  
Edmonton Symptom Assessment Scale ◽  
Patient Health ◽  
Symptom Assessment Scale

AbstractObjectiveClinical observations indicate that patients with advanced cancer and depression report higher symptom burden than nondepressed patients. This is rarely examined empirically. Study aim was to investigate the association between self-reported depression disorder (DD) and symptoms in patients with advanced cancer controlled for prognostic factors.MethodThe sample included 935 patients, mean age 62, 52% males, from an international multicentre observational study (European Palliative Care Research Collaborative – Computerised Symptom Assessment and Classification of Pain, Depression and Physical Function). DD was assessed by the Patient Health Questionnaire-9 and scored with Diagnostic and Statistical Manual of Mental Disorder-5 algorithm for major depressive disorder, excluding somatic symptoms. Symptom burden was assessed by summing scores on somatic Edmonton Symptom Assessment Scale (ESAS) symptoms, excluding depression, anxiety, and well-being. Item-by-item scores and symptom burden of those with and without DD were compared using nonparametric Mann-Whitney U tests. The relative importance of sociodemographic, medical, and prognostic factors and DD in predicting symptom burden was assessed by hierarchical, multiple regression analyses.ResultPatients with DD reported significantly higher scores on ESAS items and a twofold higher symptom burden compared with those without. Factors associated with higher symptom burden were as follows. Diagnosis: lung (β = 0.15, p < 0.001) or breast cancer (β = 0.08, p < 0.05); poorer prognosis: high C-reactive protein (β = 0.08, p < 0.05), lower Karnofsky Performance Status (β = −0.14, p < 0.001), and greater weight loss (β = −0.15, p < 0.001); taking opioids (β = 0.11, p < 0.01); and having DD (β = 0.23, p < 0.001). The full model explained 18% of the variance in symptom burden. DD explained 4.4% over and above that explained by all the other variables.Significance of resultsDepression in patients with advanced cancer is associated with higher symptom burden. These results encourage improved routines for identifying and treating those suffering from depression.

scholarly journals Patterns of Opioid Prescription, Use, and Costs Among Patients With Advanced Cancer and Inpatient Palliative Care Between 2008 and 2014

2019 ◽  
Vol 15 (1) ◽  
pp. e74-e83 ◽  
Author(s):  
Sriram Yennurajalingam ◽  
Zhanni Lu ◽  
Suresh K. Reddy ◽  
EdenMae C. Rodriguez ◽  
Kristy Nguyen ◽  
...  
Keyword(s):  
Palliative Care ◽  
Advanced Cancer ◽  
Symptom Assessment ◽  
Patient Characteristics ◽  
Opioid Prescription ◽  
Patients With Cancer ◽  
Edmonton Symptom Assessment Scale ◽  
Symptom Assessment Scale ◽  
Symptom Changes

PURPOSE: An understanding of opioid prescription and cost patterns is important to optimize pain management for patients with advanced cancer. This study aimed to determine opioid prescription and cost patterns and to identify opioid prescription predictors in patients with advanced cancer who received inpatient palliative care (IPC). MATERIALS AND METHODS: We reviewed data from 807 consecutive patients with cancer who received IPC in each October from 2008 through 2014. Patient characteristics; opioid types; morphine equivalent daily dose (MEDD) in milligrams per day of scheduled opioids before, during, and after hospitalization; and in-admission opioid cost per patient were assessed. We determined symptom changes between baseline and follow-up palliative care visits and the in-admission opioid prescription predictors. RESULTS: A total of 714 (88%) of the 807 patients were evaluable. The median MEDD per patient decreased from 150 mg/d in 2008 to 83 mg/d in 2014 ( P < .001). The median opioid cost per patient decreased and then increased from $22.97 to $40.35 over the 7 years ( P = .03). The median MEDDs increased from IPC to discharge by 67% ( P < .001). The median Edmonton Symptom Assessment Scale pain improvement at follow-up was 1 ( P < .001). Younger patients with advanced cancer (odds ratio [OR[, 0.95; P < . 001) were prescribed higher preadmission MEDDs (OR, 1.01; P < .001) more often in the earlier study years (2014 v 2009: OR, 0.18 [ P = .004] v 0.30 [ P = .02]) and tended to use high MEDDs (> 75 mg/d) during hospitalization. CONCLUSION: The MEDD per person decreased from 2008 to 2014. The opioid cost per patient decreased from 2008 to 2011 and then increased from 2012 to 2014. Age, prescription year, and preadmission opioid doses were significantly associated with opioid doses prescribed to patients with advanced cancer who received IPC.

The influence of a cachexia clinic on palliative care integration in oncology.

2017 ◽  
Vol 35 (31_suppl) ◽  
pp. 124-124
Author(s):  
Diane Portman ◽  
Sarah Thirlwell ◽  
Kristine A. Donovan
Keyword(s):  
Palliative Care ◽  
Weight Loss ◽  
Advanced Cancer ◽  
Symptom Burden ◽  
Symptom Assessment ◽  
Cancer Center ◽  
Edmonton Symptom Assessment Scale ◽  
Symptom Assessment Scale ◽  
The Impact

124 Background: Appetite and weight loss are common in patients with advanced cancer and specialized cachexia clinics have been established to address these symptoms. Given the association between anorexia/cachexia and other adverse symptoms, these patients may also benefit from specialty level palliative care (PC). However, referral to outpatient specialty level PC is often delayed or does not occur. We sought to examine the prevalence of other factors associated with appetite and weight loss in patients with advanced cancer and the impact of a specialized cachexia clinic on identification and treatment of other PC needs. Methods: The records of patients referred by their Oncologist to the cachexia clinic of a cancer center from August 2016 to June 2017 were reviewed retrospectively. Subjects who had been referred to PC by their Oncologist were excluded. Patients had been assessed for symptom burden using the Edmonton Symptom Assessment Scale (ESAS-r). Patients identified with PC needs had been referred to the PC clinic for follow-up within 30 days after cachexia clinic consultation. Results: Thirty subjects were evaluated in the cachexia clinic (average age 68 years; 63% female). The predominant diagnosis was lung cancer (70%). An average of 6 symptoms per patient were in the moderate to severe range on ESAS, excluding appetite. Depression, fatigue and pain were most common. The average cachexia clinic total ESAS score was 51.61. Only 17% of patients had completed advance directives. Ninety-three % of patients were referred to PC and 68% were seen. The average number of PC visits was 2.79. Within the PC clinic, advance directive completion increased to 37%, goals of care discussion occurred with 50% and 17% received hospice referrals. At the most recent follow-up in the PC clinic, the average total ESAS score had decreased by 11.44 (22%) and all ESAS item scores were improved on average. Conclusions: The cachexia clinic proved a useful means to identify other PC needs and achieve effective PC referrals. We suggest this is proof of concept that specialty clinics can be a meaningful way to achieve an earlier entry point to comprehensive PC in patients who were not previously referred by their Oncologists.

scholarly journals “Truly holistic?” Differences in documenting physical and psychosocial needs and hope in Portuguese palliative patients

2020 ◽  
pp. 1-6
Author(s):  
Miguel Julião ◽  
Maria Ana Sobral ◽  
Paula Calçada ◽  
Bárbara Antunes ◽  
Baltazar Nunes ◽  
...  
Keyword(s):  
Life Experience ◽  
Performance Status ◽  
Descriptive Analysis ◽  
Symptom Assessment ◽  
Well Being ◽  
Shortness Of Breath ◽  
Psychosocial Needs ◽  
Edmonton Symptom Assessment Scale ◽  
Will To Live ◽  
Symptom Assessment Scale

Abstract Objective Palliative care (PC) aims to improve patients' and families' quality of life through an approach that relieves physical, psychosocial, and spiritual suffering, although the latter continues to be under-assessed and under-treated. This study aimed to describe the prevalence of physical, psychosocial, and hope assessments documented by a PC team in the first PC consultation. Method The retrospective descriptive analysis of all first PC consultations registered in our anonymized database (December 2018–January 2020), searching for written documentation regarding (1) Edmonton Symptom Assessment Scale (ESAS) physical subscale (pain, tiredness, nausea, drowsiness, appetite, shortness of breath, constipation, insomnia, and well-being), (2) the single question “Are you depressed?” (SQD), (3) the question “Do you feel anxious?” (SQA), (4) feeling a burden, (5) hope-related concerns, (6) the dignity question (DQ), and (7) will to live (WtL). Results Of the 174 total of patients anonymously registered in our database, 141 PC home patients were considered for analysis; 63% were male, average age was 70 years, the majority had malignancies (82%), with a mean performance status of 52%. Evidence of written documentation was (1) ESAS pain (96%), tiredness (89%), nausea (89%), drowsiness (79%), appetite (89%), shortness of breath (82%), constipation (74%), insomnia (72%), and well-being (52%); (2) the SQD (39%); (3) the SQA (11%); (4) burden (26%); (5) hope (11%); (6) the DQ (33%); and (7) WtL (33%). Significant differences were found between the frequencies of all documented items of the ESAS physical subscale (29%), and all documented psychosocial items (SQD + SQA + burden + DQ) (1%), hope (11%), and WtL (33%) (p = 0.0000; p = 0.0005; p = 0.0181, respectively). Significance of results There were differences between documentation of psychosocial, hope, and physical assessments after the first PC consultation, with the latter being much more frequent. Further research using multicenter data is now required to help identify barriers in assessing and documenting non-physical domains of end-of-life experience.

Frequency and characteristics of cancer-related drowsiness (CRD or excessive daytime sleepiness) in patients with advanced cancer: Results of a prospective survey at a tertiary cancer center.

2014 ◽  
Vol 32 (31_suppl) ◽  
pp. 131-131
Author(s):  
Sriram Yennu ◽  
Dave Balachandran ◽  
Sandra L. Pedraza ◽  
Elyssa A Berg ◽  
Gary B. Chisholm ◽  
...  
Keyword(s):  
Advanced Cancer ◽  
Depression Scale ◽  
Symptom Assessment ◽  
Well Being ◽  
Severity Index ◽  
Cancer Center ◽  
P Value ◽  
Advanced Cancer Patients ◽  
Opioid Dose ◽  
Edmonton Symptom Assessment Scale

131 Background: CRD is extremely distressing but treatable symptom to the advanced cancer patients (ACP). There are limited studies to evaluate the frequency and characteristics of CRD. The aim of this study was to identify the frequency, and factors associated with severity of CRD. Secondary aim was to determine the screening performance Edmonton Symptom Assessment Scale (ESAS)-drowsiness item against the Epworth Sleepiness Scale (ESS). Methods: We prospectively assessed 180 consecutive ACP at a tertiary cancer hospital. After obtaining signed consent, the patients completed ESAS, Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI); ESS (≥10 diagnostic of CRD), Hospital Anxiety Depression Scale (HADS), STOP-Bang Screening Scale (SBS), and Screening tool for RLS. We determined epidemiological performance, spearman correlations, regression analysis, receiver operated characteristics of CRD. Results: Of the180 patients assessed, 51% were female, CRD was found in 50% ACP, median scores(IQR) ESS: 11(7-14); ESAS- drowsiness item was 5 (2-6); PSQI was 8(5-11); ISI (13 (5-19); SBS 3(2-4); HADS-D 6(3-10). Sleep apnea was found in 61%; and RLS in 38%. ESAS-D was associated with other ESAS items[r, p-value] Sleep (0.38, < 0.0001); pain (0.3, < 0.0001); fatigue(0.51, < 0.0001); depression(0.39, < 0.0001); anxiety(0.44, < 0.0001); shortness of breath(0.32, < 0.0001); anorexia(0.36, < 0.0001), FWB(0.41, < 0.0001), and ESS (0.24, 0.001), Opioid dose [MEDD] (0.19, 0.01). Multivariate analysis found no independent predictors except ISI (OR 2.35; 0.036), ESAS Fatigue (OR 9.08, <0.0001), ESAS Anxiety (3.0, 0.009); feeling of well-being (OR 2.27, p=0.04). An ESAS- drowsiness cut-off score of ≥ 3(of 10) resulted in a sensitivity and specificity of 81% and 32% and of 70% and 44% in the training and validation samples, respectively. Conclusions: Clinically significant CRD was associated with increased fatigue, anxiety, sleep disturbance and worse feeling of well-being. These symptoms should be routinely assessed and treated in ACP with CRD. ESAS-drowsiness score of ≥3 of 10 is most useful for screening CRD.

Caregivers' accuracy in reporting patients' symptom: A preliminary report.

2016 ◽  
Vol 34 (26_suppl) ◽  
pp. 64-64 ◽  
Author(s):  
Paola Langer ◽  
Pedro Emilio Perez-Cruz ◽  
Cecilia Carrasco Escarate ◽  
Pilar Bonati ◽  
Bogomila Batic ◽  
...  
Keyword(s):  
Palliative Care ◽  
Advanced Cancer ◽  
Symptom Control ◽  
Symptom Assessment ◽  
Continuous Variable ◽  
Advanced Cancer Patients ◽  
Symptom Intensity ◽  
Edmonton Symptom Assessment Scale ◽  
Symptom Assessment Scale ◽  
Positive Correlations

64 Background: Improving symptom control during end of life (EOL) is a core goal of palliative care. When patients are not able to report their symptoms, caregivers (CG) report symptom intensity as surrogates. Data show that there is good agreement between patients and CG in reporting symptom intensity. However, little is known about factores that influence CGs’ accuracy. The aim of the study was to determine CG accuracy of advanced cancer patients’ symptoms and to identify CG factors that could modify it. Methods: In this prospective study, patients with advanced cancer enrolled in the National Program of Palliative Care at a public Hospital in Santiago, Chile and their CGs independently scored ten patients’ symptoms using the Edmonton Symptom Assessment Scale (ESAS). Correlation between patient and CG scores were estimated for each symptom. Differences between patient and CG scores were calculated for each symptom and were transformed into positive values. A continuous variable was created with the sum of all the differences as an indicator of caregiver overall accuracy, with smaller scores meaning better accuracy. CG depression, anxiety (HADS) and burden (ZARIT) were also assessed. Results: 36 patients and their CG were included in this preliminary analysis. Mean patient age was 64, 20 (56%) females, 13 (36%) had GI cancer, 7 (19%) lung cancer and 16 (45%) other. Mean caregiver age was 53, 25 (69%) female. We found positive correlations between patients’ and caregivers’ assessment of pain, fatigue, nausea, anorexia, dyspnea, depression and insomnia (r > 0.3 and p < .05 for each symptom). CG accuracy ranged between 10 and 44 points (mean 25, standard deviation 9) and was not associated with CG age, gender, depression, anxiety or burden. CG accuracy was negatively associated with CG worrying thoughts as assessed by one of the HADS questions (Coef -3.99, p = .015), meaning that CG were more accurate when their worrying thoughts were higher. This association remained significant when adjusted by CG depression, anxiety and burden. Conclusions: CG are more accurate in reporting patient symptoms when their levels of worrying thoughts are higher. This information may have implications in interpreting CG report during EOL.

The Effect of Combined Drug Management and an Exercise Program on Symptoms and the Happiness Level in Elderly Women

2020 ◽  
Vol 33 (1) ◽  
pp. 14-20
Author(s):  
Seçil Gülhan Güner ◽  
Arzu Erden ◽  
Nesrin Nural
Keyword(s):  
Elderly Women ◽  
Short Form ◽  
Exercise Program ◽  
Symptom Assessment ◽  
Well Being ◽  
Drug Management ◽  
Edmonton Symptom Assessment Scale ◽  
Post Test ◽  
Symptom Assessment Scale

The aim of this study was to determine the effect of combined drug management and an exercise program on symptoms and the happiness levels of elderly women people living at home. This interventional study included a total of 35 women, aged 65 to 74 years, who were registered at the Family Healthcare Centre. A 14-week program was combined with exercise and drug management. Pre-test and post-test evaluations results were recorded. The Edmonton Symptom Assessment Scale (ESAS), Oxford Happiness Questionnaire-Short Form (OHQ-SF) and a sociodemographic form and Follow-Up form were used for data collection. The mean ESAS points of the symptoms of pain, tiredness, sadness, and insomnia showed a significant decrease after intervention and the sense of well-being improved ( p < .001). A statistically significant increase was determined in the happiness levels of the participants after intervention. The combined program of drug management and exercise was found to be effective in raising happiness levels and reducing symptoms in elderly women.

Aberrant opioid use behaviour in advanced cancer

2020 ◽  
pp. bmjspcare-2020-002606
Author(s):  
Sebastiano Mercadante ◽  
Claudio Adile ◽  
Walter Tirelli ◽  
Patrizia Ferrera ◽  
Italo Penco ◽  
...  
Keyword(s):  
High Risk ◽  
Advanced Cancer ◽  
Depression Scale ◽  
Brief Pain Inventory ◽  
Symptom Assessment ◽  
Well Being ◽  
Assessment Scale ◽  
Opioid Use ◽  
Edmonton Symptom Assessment Scale

ObjectivesTo evaluate the presence of aberrant behaviour in a consecutive sample of patients with advanced cancer treated with opioids in a country like Italy, with its peculiar attitudes towards the use opioids. The second objective was to detect the real misuse of opioids in clinical practice.MethodsProspective observational study in two palliative care units in Italy in a period of 6 months. At admission the Edmonton Symptom Assessment Scale, the Memorial Delirium Assessment Scale, Brief Pain Inventory (BPI) and the Hospital Anxiety Depression Scale were measured. For detecting the risk of aberrant opioid use, the Screener and Opioid Assessment for Patients With Pain (SOAAP), the Opioid Risk Tool (ORT), the Cut Down-Annoyed-Guilty-Eye Opener (CAGE) questionnaire adapted to include drug use (CAGE-AID) were used. Aberrant behaviours displayed at follow-up within 1 month were recorded.ResultsOne-hundred and thirteen patients with advanced cancer were examined. About 35% of patients were SOAPP positive. There was correlation between SOAPP, CAGE-AID and ORT. SOAPP was independently associated with a lower Karnofsky level, pain intensity, poor well-being, BPI pain at the moment. No patient displayed aberrant behaviours, despite having a moderate-high risk.ConclusionsDespite a high percentage of patients showed a high risk of aberrant behaviours, no patient displayed clinical aberrant behaviours after 1 month-follow-up. This does not exempt from continuous monitoring for patients who are at risk.

The Quebec Cannabis Registry: a pharmacovigilance and effectiveness study on the use of medical cannabis in cancer patients.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 12109-12109
Author(s):  
Antonio Vigano ◽  
Michelle Canac-Marquis ◽  
Rihab Gamaoun ◽  
Pierre Beaulieu ◽  
Andrée Neron ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Repeated Measures ◽  
Brief Pain Inventory ◽  
Symptom Assessment ◽  
Well Being ◽  
Population Based ◽  
Pain Severity ◽  
Medical Cannabis ◽  
Edmonton Symptom Assessment Scale ◽  
Symptom Assessment Scale

12109 Background: The Quebec Cannabis Registry (QCR) was launched in 2015 to allow physicians to prescribe medical cannabis (MC) in the province of Quebec, Canada. This study aimed to investigate the safety and effectiveness of MC in cancer patients using pharmacovigilance data prospectively collected for up to 24 months. Methods: Patients were enrolled in the QCR between May 2015 and October 2018 and followed every 3 months. Study outcomes included adverse events (AE), pain severity and interference (Brief-Pain Inventory), wellbeing (Revised-Edmonton Symptom Assessment Scale) and overall health scale (EQ5D5L) at baseline and at each follow-up (F-UP). Significance of changes over time were assessed using repeated-measures ANOVA. Results: Out of the 2991 patients enrolled in the QCR, 358 (12.8%) were cancer patients (mean age 57.7 (± 14.6); 171 (47.8%) males). The main cancer types were breast (16.2%), lung (11.7%), leukemia (11.5%) and colorectal (11.2%). MC was prescribed primarily for pain (72.1%), anxiety (4.7%), nausea (4.5%), anorexia (3.9%), and insomnia (3.1%). A total of 13 patients (3.6%) reported AE with only three being serious (one unrelated to MC: stroke; and two possibly related: diarrhea, from CBD oil overdose and pneumonia from smoking MC). Mean scores significantly (p < 0.05) improved between baseline and 3 months F-UP for pain severity (4.8 ± 1.5 vs 4.1 ± 1.8), pain interference (4.6 ± 1.8 vs 3.8 ± 1.7), and the overall health scale (60 ± 21 vs 71 ± 18). Well-being scores also significantly improved between baseline and 6 months F-UP (4.4 ± 2.1 vs 3.5 ± 2.8). Conclusions: Population-based data shows that cancer patients can benefit safely and effectively from MC as a complementary treatment, when prescribed and monitored under medical-nursing supervision.

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