scholarly journals Sativex oromucosal spray as adjunctive therapy in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy: two double-blind, randomized, placebo-controlled phase 3 studies

2017 ◽  
Vol 11 (3) ◽  
pp. 119-133 ◽  
Author(s):  
Marie T Fallon ◽  
Eberhard Albert Lux ◽  
Robert McQuade ◽  
Sandro Rossetti ◽  
Raymond Sanchez ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Cancer Patients ◽  
Treatment Period ◽  
Advanced Cancer ◽  
Treatment Effect ◽  
Opioid Therapy ◽  
Advanced Cancer Patients ◽  
Phase 3 ◽  
Double Blind ◽  
The World

Background: Opioids are critical for managing cancer pain, but may provide inadequate relief and/or unacceptable side effects in some cases. Objective: To assess the analgesic efficacy of adjunctive Sativex (Δ9-tetrahydrocannabinol (27 mg/mL): cannabidiol (25 mg/mL)) in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy. Methods: This report describes two phase 3, double-blind, randomized, placebo-controlled trials. Eligible patients had advanced cancer and average pain numerical rating scale (NRS) scores ≥4 and ≤8 at baseline, despite optimized opioid therapy. In Study-1, patients were randomized to Sativex or placebo, and then self-titrated study medications over a 2-week period per effect and tolerability, followed by a 3-week treatment period. In Study-2, all patients self-titrated Sativex over a 2-week period. Patients with a ≥15% improvement from baseline in pain score were then randomized 1:1 to Sativex or placebo, followed by 5-week treatment period (randomized withdrawal design). Results: The primary efficacy endpoint (percent improvement (Study-1) and mean change (Study-2) in average daily pain NRS scores) was not met in either study. Post hoc analyses of the primary endpoints identified statistically favourable treatment effect for Sativex in US patients <65 years (median treatment difference: 8.8; 95% confidence interval (CI): 0.00–17.95; p = 0.040) that was not observed in patients <65 years from the rest of the world (median treatment difference: 0.2; 95% CI: −5.00 to 7.74; p = 0.794). Treatment effect in favour of Sativex was observed on quality-of-life questionnaires, despite the fact that similar effects were not observed on NRS score. The safety profile of Sativex was consistent with earlier studies, and no evidence of abuse or misuse was identified. Conclusions: Sativex did not demonstrate superiority to placebo in reducing self-reported pain NRS scores in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy, although further exploration of differences between United States and patients from the rest of the world is warranted.

Frequency, predictors, and outcomes of urine drug test among patients with advanced cancer on chronic opioid therapy at an outpatient supportive care clinic.

2016 ◽  
Vol 34 (26_suppl) ◽  
pp. 94-94
Author(s):  
Joseph Anthony Arthur ◽  
Tonya Edwards ◽  
David Hui ◽  
Jessica Marie Waletich-Flemming ◽  
Suresh K. Reddy ◽  
...  
Keyword(s):  
Supportive Care ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Opioid Therapy ◽  
Cancer Stage ◽  
Chronic Opioid Therapy ◽  
Advanced Cancer Patients ◽  
Care Clinic ◽  
Urine Drug ◽  
Outpatient Supportive Care

94 Background: Data on the utilization and outcomes of urine drug tests (UDT) among advanced cancer patients is limited. The main objective of this study was to determine the factors associated with UDT ordering and results in advanced cancer outpatients. Methods: A retrospective chart review of 1058 patients seen from March 2014 to November 2015 at an outpatient supportive care clinic was conducted. Sixty-one patients on chronic opioid therapy who underwent UDT were identified. A control group of 120 patients who did not undergo UDT was selected for comparison of information on demographic and clinical characteristics. Results: 61/1058 patients (6%) underwent UDT. 33/61 patients (54%) had abnormal results. Multivariate analysis found that the odds ratio for UDT ordering was 3.9 in CAGE positive patients (p = 0.002), 4.41 in patients less than 45years (p < 0.001), 5.58 in patients with moderate to severe pain (ESAS pain score ≥ 4) (p < 0.001), 0.27 in patients with advanced cancer stage, (p = 0.008), and 0.25 in patients with moderate to severe fatigue (p = 0.001). Among 52 abnormal UDT results in 33 patients, the most common opioid findings were: prescribed opioids absent in urine (14/52, 27%) and un-prescribed opioids in urine (13/52, 25%). Conclusions: UDT was used infrequently among advanced cancer patients receiving outpatient chronic opioid therapy. Younger age, CAGE positivity, early cancer stage or NED status, higher pain intensity, and lower fatigue were significant predictors of UDT ordering. More than 50% of UDTs were abnormal. More research is necessary to better characterize aberrant opioid use in advanced cancer patients.

Introducing psychology services to advanced cancer patients: A randomized double‐blind trial

2019 ◽  
Vol 28 (10) ◽  
pp. 1978-1986
Author(s):  
Sujin Ann‐Yi ◽  
Kimberson Tanco ◽  
Cindy L. Carmack ◽  
Diane D. Liu ◽  
Swati Bansal ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Advanced Cancer ◽  
Double Blind Trial ◽  
Advanced Cancer Patients ◽  
Double Blind ◽  
Blind Trial

Control of chronic pain in very advanced cancer patients with morphine hydrochloride administered by oral, rectal and sublingual route

Pain ◽  
1982 ◽  
Vol 14 (2) ◽  
pp. 196
Author(s):  
F. Pannuti ◽  
A. P. Rossi ◽  
G. Iafelice ◽  
D. Marraro ◽  
P. Camera ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Advanced Cancer Patients ◽  
Morphine Hydrochloride

Pain management and related factors in advanced cancer patients who initiated opioid therapy in an outpatient setting

2005 ◽  
Vol 3 (4) ◽  
pp. 301-309 ◽  
Author(s):  
RIEKO KIMURA ◽  
SAORI HASHIGUCHI ◽  
MASAKO KAWA ◽  
MITSUNORI MIYASHITA ◽  
TOMOYO SASAHARA ◽  
...  
Keyword(s):  
Pain Management ◽  
Pain Relief ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Self Efficacy ◽  
Opioid Therapy ◽  
Outpatient Setting ◽  
Pain Intensity Score ◽  
Advanced Cancer Patients ◽  
Opioid Administration

Objective: The aim of this study was to clarify the state of pain management in Japanese patients with advanced cancer who initiated opioid therapy in an outpatient setting.Methods: Interview surveys using questionnaires were conducted and medical records were reviewed. Pain relief was defined as >33% decrease in worst pain intensity score, and significance of early pain relief was investigated in terms of changing self-efficacy for activities of daily living (ADL). Factors related to early pain relief were also investigated.Results: The study was conducted between June and December 2003, on 20 patients (13 women, 7 men; mean age, 59 years). Compared to score at initiation of opioid administration (Numerical Rating Scale, 8.3 ± 1.3), pain relief was generally insufficient at 2 weeks (early pain relief ratio was only 42%). Patients with sufficient pain relief at 2 weeks displayed significant improvements in numerous ADL functions and symptom-coping efficacy (p = 0.037), confirming the importance of early pain relief. Early pain relief was associated with high frequency of hospital visits before opioid administration and absence of sudden excavation within the first 2 weeks.Significance of results: Result of this study indicated insufficient pain relief at an outpatients setting with advanced cancer patients. In the meantime, patients had who their pain decrease after 2 weeks also had improved ADL and self-efficacy at the same time. These findings suggest that to achieve early pain relief in an outpatient setting, clinical staff must assess pain earlier and inform patients of possible breakthrough pain following opioid administration and available treatments for such occurrences.

scholarly journals Study Protocol for the Evaluation of Individual Psychological Interventions for Family Caregivers of Advanced Cancer Patients

2021 ◽  
Vol 11 ◽  
Author(s):  
Min Yang ◽  
Rui Sun ◽  
Yanfeng Wang ◽  
Haiyan Xu ◽  
Baohua Zou ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Family Caregivers ◽  
Treatment Period ◽  
Advanced Cancer ◽  
Psychological Intervention ◽  
The Self ◽  
Psychological Status ◽  
Advanced Cancer Patients ◽  
High Quality ◽  
Psychological Consultation

Background: Both anxiety and depression in family caregivers (FCs) of advanced cancer patients are common, and they have a negative influence on both the FCs and the patients. Some studies suggested that a variety of interventions could alleviate the psychological symptoms of FCs. However, there is no consensus on much more effective methods for intervention, and relatively high-quality research is blank in psychological problems of these population in China. The validity of mindfulness-based stress reduction (MBSR) and psychological consultation guided by the needs assessment tool (NST) in the psychological status of caregivers will be compared in this study to select a more suitable intervention for the FCs of advanced cancer patients in China.Methods and Analysis: A randomized N-of-1 trial would be conducted at the Cancer Hospital, Chinese Academy of Medical Sciences. Fifty eligible FCs of advanced cancer patients will be recruited, and all will receive three cycles of psychological intervention treatment, with each cycle including both of MBSR and psychological consultation guided by the NST. MBSR and psychological consultation guided by the NST will be compared with each other in each cycle, and the intervention sequence will be based on the random number table generated after the informed consent has been completed. Each treatment period is 2 weeks, and the interval between different treatment cycles or treatment periods is 1 week. The self-reported scales are measured at the beginning and end of each treatment period, including the Self-Rating Anxiety Scale (SAS), the Self-Rating Depression Scale (SDS), Distress Thermometer (DT), Zarit Burden Interview (ZBI), Chinese version of the Medical Outcomes Study 12-item Short Form (C-SF-12), and Family Carer Satisfaction with Palliative Care scale (FAMCARE-2).Dissemination: The protocol of the study was approved by the Institutional Review Board of the Ethical Committee of the Cancer Hospital, Chinese Academic of Medical Science. The results will be published in a peer-reviewed medical journal. The study is registered at Chinese Clinical Trials Registry with the trial registration number chiCTR2000033707. This study employs an innovative methodological approach on the effectiveness of MBSR and psychological consultation guided by the NST for psychological status of FCs of advanced cancer patients. The findings of the study will be helpful to provide high-quality evidence-based medical data for psychological intervention of FCs of advanced cancer patients, and guide clinicians on best quality treatment recommendations.

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