Breakthrough Cancer Pain Research Articles

215 Ultrasound-Guided Erector Spinae Plane Block for Breakthrough Cancer Pain in the Emergency Department: Case Series

215 Ultrasound-Guided Erector Spinae Plane Block for Breakthrough Cancer Pain in the Emergency Department: Case Series

Efficacy and safety of fentanyl inhalant for the treatment of breakthrough cancer pain: a multicenter, randomized, double-blind, placebo-controlled trial

BackgroundBreakthrough cancer pain (BTcP) has a negative impact on patients’ quality of life, general activities, and is related to worse clinical outcomes. Fentanyl inhalant is a hand-held combination drug-device delivery system providing rapid, multi-dose (25μg/dose) administration of fentanyl via inhalation of a thermally generated aerosol. This multicenter, randomized, placebo-controlled, multiple-crossover, double-blind study evaluated the efficacy, safety, and tolerability of fentanyl inhalant in treating BTcP in opioid-tolerant patients.MethodsThe trial was conducted in opioid-tolerant cancer patients with 1 ~ 4 BTcP outbursts per day. Each patient was treated and observed for 6 episodes of BTcP (4 with fentanyl inhalant, 2 with placebo). During each episode of targeted BTcP, patients were allowed up to six inhalations, with an interval of at least 4 min between doses. Primary outcome was the time-weighted sum of PID (pain intensity difference) scores at 30 min (SPID30).ResultsA total of 335 BTcP episodes in 59 patients were treated. The mean SPID30 was -97.4 ± 48.43 for fentanyl inhalant-treated episodes, and -64.6 ± 40.25 for placebo-treated episodes (p < 0.001). Significant differences in PID for episodes treated with fentanyl inhalant versus placebo was seen as early as 4 min and maintained for up to 60 min. The percentage of episodes reported PI (pain intensity) scores ≤ 3, a ≥ 33% or ≥ 50% reduction in PI scores at 30 min, PR30 (pain relief scores at 30 min) and SPID60 favored fentanyl inhalant over placebo. Only 4.4% of BTcP episodes required rescue medication in fentanyl inhalant group. Most AEs were of mild or moderate severity and typical of opioid drugs.ConclusionTreatment with fentanyl inhalant was shown to be a promising therapeutic option for BTcP, with significant pain relief starting very soon after dosing. Confirmation of effectiveness requires a larger phase III trial.Trial registrationClinicalTrials.gov: NCT05531422 registered on 6 September 2022 after major amendment, NCT04713189 registered on 14 January 2021.

Assessing Gender Differences for Non-Predictable Breakthrough Cancer Pain Phenomenon: A Secondary Analysis from IOPS-MS Study.

Breakthrough cancer pain (BTcP) is a temporary exacerbation of pain that "breaks through" a phase of adequate pain control by an opioid-based therapy. The non-predictable BTcP (NP-BTcP) subtype occurs in the absence of any specific activity. Evidence showed that gender differences exist in pain response sensitivity and clinical pain risk. This analysis aimed to signify the gender differences for the NP-BTcP phenomenon. This is a secondary analysis of the Italian Oncologic Pain multiSetting-Multicentric Survey (IOPS-MS), the largest study on BTcP. The subset of NP-BTcP cases for non-gender-specific cancer was considered. Univariable and multivariate analyses were conducted to identify gender differences for the NP-BTcP profile about its intensity, number of episodes per day, and type. A metastatic status-stratified analysis was performed to compare gender with the main clinical variables among the population with NP-BTcP. Males exhibited a higher occurrence of BTcP in the thorax region compared to females (15% vs 11%, respectively, p = 0.03). Males also had a higher onset of BTcP, a higher BTcP therapy dosage (33% vs 28%, p = 0.04, mean: 201 vs 186, p = 0.02) and a lower Karnofsky score (mean: 46.9 vs 49.2, p = 0.03) compared to females. Similar gender differences were found for metastatic patients in the BTcP site (14% vs 8.5%, respectively; p = 0.01), peak onset (33% vs 27%, p = 0.02), BTcP therapy dosage (199 vs 185, p=0.04), and Karnofsky score (mean 47.5 vs 50.4, p = 0.009). Phenotype 2 was more characterized by non-metastatic males (41% vs 23%, p = 0.020) while non-metastatic females presence was predominant among others. In this study, gender differences according to site, onset and dosage of BTcP were found. The phenotype characterization of BTcP needs to be further investigated for a possible useful function in the management of cancer-related pain in non-metastatic patients.

Validation of the Spanish Version of the Breakthrough Pain Assessment Tool in Patients With Cancer.

Assessment of breakthrough pain is essential for adequate management of cancer pain. The Breakthrough Pain Assessment Tool (BAT) has been proven to be a brief, multidimensional, and reliable questionnaire for the assessment of breakthrough cancer pain (BTCP). Currently, there are no validated instruments in Spanish that allow assessing BTCP. The objective of this study was to validate the Breakthrough Pain Assessment Tool - Spanish (BAT-S) version of the BAT in adult patients with cancer. The BAT-S was tested in a prospective observational study conducted in adult patients with cancer-related pain and treated in a comprehensive cancer center in Mexico. We conducted a forward-backward translation and cross-cultural equivalence test in the Spanish language. The psychometric properties in patients with cancer were assessed using factor analysis, reliability, and validity. To assess reliability, the Kappa test and the intra-class correlation coefficient were used. For consistency, Cronbach's alpha test was used. Seventy patients participated in the study; 140 questionnaires were analyzed. The Spanish translation was well accepted by participants. Reliability was comprised between 0.746 for "use of analgesics" and 1.00 for "pain location." Thirteen of the 14 items had values above 0.8, and 12 above 0.9. Cronbach´s alpha coefficient was 0.7. This study confirms that BAT-S is a valid and reliable questionnaire to assess breakthrough pain in Mexican patients with cancer. This newly validated tool may be used to facilitate clinical management of primarily Spanish-speaking patients with breakthrough cancer pain. This study describes a prospective observational study to assess the validity and reliability of the Breakthrough Pain Assessment Tool in its Spanish version. The results support the use of this newly validated tool to facilitate clinical management of primarily Spanish-speaking patients with breakthrough cancer pain.

Advancing the integration of biosignal-based automated pain assessment methods into a comprehensive model for addressing cancer pain

BackgroundTailoring effective strategies for cancer pain management requires a careful analysis of multiple factors that influence pain phenomena and, ultimately, guide the therapy. While there is a wealth of research on automatic pain assessment (APA), its integration with clinical data remains inadequately explored. This study aimed to address the potential correlations between subjective and APA-derived objectives variables in a cohort of cancer patients.MethodsA multidimensional statistical approach was employed. Demographic, clinical, and pain-related variables were examined. Objective measures included electrodermal activity (EDA) and electrocardiogram (ECG) signals. Sensitivity analysis, multiple factorial analysis (MFA), hierarchical clustering on principal components (HCPC), and multivariable regression were used for data analysis.ResultsThe study analyzed data from 64 cancer patients. MFA revealed correlations between pain intensity, type, Eastern Cooperative Oncology Group Performance status (ECOG), opioids, and metastases. Clustering identified three distinct patient groups based on pain characteristics, treatments, and ECOG. Multivariable regression analysis showed associations between pain intensity, ECOG, type of breakthrough cancer pain, and opioid dosages. The analyses failed to find a correlation between subjective and objective pain variables.ConclusionsThe reported pain perception is unrelated to the objective variables of APA. An in-depth investigation of APA is required to understand the variables to be studied, the operational modalities, and above all, strategies for appropriate integration with data obtained from self-reporting.Trial registrationThis study is registered with ClinicalTrials.gov, number (NCT04726228), registered 27 January 2021, https://classic.clinicaltrials.gov/ct2/show/NCT04726228?term=nct04726228&draw=2&rank=1

Effectiveness and Safety of Sublingual Fentanyl in the Treatment of Breakthrough Cancer Pain in Older Patients with Cancer: Results from a Retrospective Observational Study

The study assessed sublingual fentanyl citrate (SFC) effectiveness and safety for breakthrough cancer pain (BtCP) in older patients. A multicenter, retrospective, observational study was conducted in three subgroups of cancer patients aged over 65 years with BtCP. The reports were collected by 20 oncologists across 12 hospitals. The primary goal was to measure changes in BtCP intensity with SFC treatment over 30 days; secondary objectives included pain relief onset and adverse events. A total of 127 patients with long-term cancer (mean: 3.3 years) were recruited. All of them had BtCP, mostly of mixed origin (62.5%). A significantly lower dose was needed in the high-age group at the final visit compared to baseline (212.90 ± 200.45 mcg vs. 206 ± 167.08 mcg; p = 0.000). Pain intensities at the beginning of the flare and at 30 min after SFC administration were significantly lower when the last and first visits were compared (1.9 vs. 2.3, p = 0.000; and 6.2 vs. 6.8 p = 0.006, respectively). The onset of analgesia was significantly more rapid for half of the patients ≥75 years, compared with 65–69 and 70–74 age groups. SFC appears then to be effective, well-tolerated, and safe to treat BtCP in older cancer patients.

Effectiveness of fentanyl buccal soluble film in cancer patients with inadequate breakthrough pain control

BackgroundClinical evidence for the rapidity and effectiveness of fentanyl buccal soluble film (FBSF) in reducing pain intensity of breakthrough cancer pain (BTcP) remains inadequate. This study aimed to evaluate the efficacy of FBSF proportional to the around-the‐clock (ATC) opioid regimens in rapidly relieving the intensity of BTcP episodes by determining the percentage of patients requiring further dose titration.MethodsThe study procedure included a dose-finding period followed by a 14-day observation period. Pain intensity was recorded with a Numeric Rating Scale (NRS) at onset and 5, 10, 15, and 30 min after FBSF self-administration. Meaningful pain relief was defined as the final NRS score ≤ 3. Satisfaction survey was conducted for each patient after treatment using the Global Satisfaction Scale.ResultsA total of 63 BTcP episodes occurred in 30 cancer patients. Only one patient required rescue medication at first BTcP episode and then achieved meaningful pain relief after titrating FBSF by 200 µg. Most BTcP episodes relieved within 10 min. Of 63 BTcP episodes, 30 (47.6%), 46 (73.0%), and 53 (84.1%) relieved within 5, 10, and 15 min after FBSF administration. Only grade 1/2 adverse events were reported, including somnolence, malaise, and dizziness. Of the 63 BTcP episodes, 82.6% were rated as excellent/good satisfaction with FBSF.ConclusionFBSF can be administrated “on demand” by cancer patients at the onset of BTcP, providing rapid analgesia by achieving meaningful pain relief within 10 min.Trial registrationThis study was retrospectively registered 24 December, 2021 at Clinicaltrial.gov (NCT05209906): https://clinicaltrials.gov/study/NCT05209906.

Inhaled fentanyl aerosol through a drug-device combination for breakthrough cancer pain: A multicenter, randomized, double-blind, placebo-controlled trial.

e24058 Background: Breakthrough cancer pain (BTcP) can significantly impact the life quality of the cancer patient. Wide-used rapid-onset opioids (ROOs) for BTcP are transmucosal fentanyl-based preparations. Inhaled fentanyl demonstrated similar pharmacokinetic properties as intravenous administration in healthy volunteers. Fentanyl aerosol can be generated via hand-held drug-device delivery system, providing rapid, consistent multi-dose administration. Fentanyl inhalant was explored as alternative treatment of BTcP in cancer patients in this study to evaluate its efficacy, safety, and tolerability in BTcP patients with well-controlled background cancer pain. Methods: Adults ≥18 years with cancer are eligible if they were experiencing persistent cancer- or treatment-related pain with above mild severity and 1-4 episode occurrences daily. Each patient was treated and observed for 6 BTcP episodes (4 with fentanyl inhalant, 2 with placebo). During each episode, patients were allowed to inhale up to six shots within 1 hour. Pain intensity was recorded using 11-point Numerical Rating Scale (NRS) at predefined time points. The primary endpoint was the time-weighted Sum of Pain Intensity Difference scores at 30 minutes (SPID30) after the first inhalation. Results: 335 BTcP episodes in 59 patients were treated. SPID30 was analyzed using mixed model of repeated measures with treatment (fentanyl inhalant or placebo), BTcP episode, baseline pain intensity score as fixed factors, and subject as random factor. Mean SPID30 ± SD was -97.4 ± 48.43 for fentanyl-treated episodes, and -64.6 ± 40.25 for placebo-treated episodes. Based on treatment adjustment in the mixed covariance model, significant difference (p &lt; 0.001) was reported with mean treatment difference of -27.7 (LS-mean ± SD, -94.2 ± 4.49 for fentanyl and -66.5 ± 4.86 for placebo). It enlarged at 60 minutes (SPID60) with a mean treatment difference of -57.9 (LS-mean ± SD, -231.4 ±105.14 for fentanyl and -162.2 ± 91.21 for placebo, p &lt; 0.001). Significant differences in PID for episodes treated with fentanyl versus placebo were seen 4 minutes after the first dosing and maintained up to 60 minutes. Other endpoints showed statistical significance favoring fentanyl treatment, including the proportion of NRS ≤ 3, NRS pain scores decreased ≥ 33% or ≥ 50% from baseline after completion of BTcP treatment within 30 minutes of first dose, and Pain Relief Score Within 30 Minutes of the First Dose (PR30). Only 4.4% of BTcP episodes required rescue medication in fentanyl group. Major adverse events were mild or moderate in severity and were typical for opioid drugs. Conclusions: Fentanyl inhalant is safe, effective, and well-tolerated for managing BTcP. It provides a non-invasive route for systemic drug delivery and can be self-administered or given by family caregivers as personalized and regular pain management. Clinical trial information: NCT05531422 .

Current Status of Cognition and Clinical Practice of Refractory Cancer Pain in Shanghai: A Questionnaire Survey.

This study aimed to assess the current status of clinical practice of refractory cancer pain (RCP) among a sample of physicians specializing in cancer pain management in Shanghai. From 2019 to 2021, a questionnaire survey was conducted among physicians engaged in diagnosis and treatment of cancer pain through the questionnaire WJX network platform in Shanghai, China. A total of 238 responses participated in the survey. This survey reports physicians' understanding and incidence rate of breakthrough cancer pain (BTCP). The choice of analgesics and satisfaction of analgesic effect were investigated. We also investigated doctors' knowledge of the diagnostic criteria for RCP and their tendency to choose analgesics. Oral immediate-release morphine and intravenous or subcutaneous morphine injection have been the common treatment approach for transient cancer pain exacerbations. The main barriers to pain management are lack of standardized treatment methods for RCP, lack of knowledge related to RCP, and single drug dosage form. Doctors believe the most necessary measures to improve the current situation of poor cancer pain control include improving medical staff's understanding and treatment techniques for RCP, updating treatment techniques and methods, and improving the configuration of drug types in medical institutions. Clinicians expect to improve understanding and treatment techniques through systematic training. Despite multiple available analgesic measures, the treatment of RCP remains challenging. Improving the understanding of medical staff towards RCP, improving treatment techniques, and increasing the accessibility of multiple drug types are important ways to improve the satisfaction of cancer pain management in the future.

The influence of ambient environmental factors on breakthrough cancer pain: insights from remote health home monitoring and a proposed data analytic approach

BackgroundBreakthrough cancer pain (BTCP) is primarily managed at home and can stem from physical exertion and emotional distress triggers. Beyond these triggers, the impact of ambient environment on pain occurrence and intensity has not been investigated. This study explores the impact of environmental factors on the frequency and severity of breakthrough cancer pain (BTCP) in the home context from the perspective of patients with advanced cancer and their primary family caregiver.MethodsA health monitoring system was deployed in the homes of patient and family caregiver dyads to collect self-reported pain events and contextual environmental data (light, temperature, humidity, barometric pressure, ambient noise.) Correlation analysis examined the relationship between environmental factors with: 1) individually reported pain episodes and 2) overall pain trends in a 24-hour time window. Machine learning models were developed to explore how environmental factors may predict BTCP episodes.ResultsVariability in correlation strength between environmental variables and pain reports among dyads was found. Light and noise show moderate association (r = 0.50–0.70) in 66% of total deployments. The strongest correlation for individual pain events involved barometric pressure (r = 0.90); for pain trends over 24-hours the strongest correlations involved humidity (r = 0.84) and barometric pressure (r = 0.83). Machine learning achieved 70% BTCP prediction accuracy.ConclusionOur study provides insights into the role of ambient environmental factors in BTCP and offers novel opportunities to inform personalized pain management strategies, remotely support patients and their caregivers in self-symptom management. This research provides preliminary evidence of the impact of ambient environmental factors on BTCP in the home setting. We utilized real-world data and correlation analysis to provide an understanding of the relationship between environmental factors and cancer pain which may be helpful to others engaged in similar work.

Breakthrough pain among cancer patients at oncology units in Northern Ethiopia; a multi-center study.

Breakthrough cancer pain (BTCP) is a transient exacerbation of pain that affects the length of hospitalization and quality of life of patients. The objective of this study was to determine the prevalence and factors associated with BTCP among cancer patients at oncology units in Northern Ethiopia in 2022. A multi-center cross-sectional study was conducted from April to June 2022. After obtaining ethical approval, data were collected prospectively from 424 adult cancer patients admitted to oncology units. Breakthrough cancer pain was assessed by the numeric rating scale. Descriptive and binary logistic regression analyses were performed to determine the factors associated with BTCP. The strength of association was described in adjusted odds ratio (AOR) with 95% confidence intervals and variables with a P-value < 0.05 were considered to have a statistically significant association with BTCP. The prevalence of BTCP among cancer patients was 41.5%. The factors that were found to be associated with BTCP were colorectal cancer (AOR: 7.7, 95% CI: 1.8, 32.3), lung cancer (AOR: 6.9, 95% CI: 1.9, 26.0), metastasis (AOR: 9.3, 95% CI: 3.0, 29.1), mild background pain (AOR: 7.5, 95% CI: 2.5, 22.6), moderate background pain (AOR: 7.0, 95% CI: 2.2, 23.1), severe background pain (AOR: 7.1, 95% CI: 2.2, 22.8), no analgesics taken for background pain (AOR: 5.1, 95% CI: 2.8, 9.3) and uncontrolled background pain (AOR: 3.3, 95% CI: 1.8, 6.1). The prevalence of BTCP was high. Colorectal cancer, lung cancer, the presence of metastasis, the presence of background pain, not taking analgesics for background pain, and uncontrolled background pain were significantly associated with BTCP.

Compliance with the breakthrough cancer pain European guidelines and impact on patients' quality of life: an observational prospective study.

This study aimed to assess the percentage of patients treated according to the European Society for Medical Oncology (ESMO) 2018 guidelines for breakthrough cancer pain (BTcP) and the impact of guidelines adherence on patients' quality of life (QoL). Adult opioid-tolerant patients diagnosed with BTcP and locally advanced or recurrent metastatic cancer with a life expectancy of >3 months prospectively were included. Patients were followed up for 28 days. Of 127 patients included, 37 were excluded due to the impossibility to establish adherence to the ESMO guidelines. Among the evaluable patients [51.1% female; with mean (SD) age of 66.4 (11.8) years], all were adherent. BTcP was diagnosed by the Association for Palliative Medicine algorithm in 47.8% of patients and by clinical experience in 52.2% of patients. The mean number of daily BTcP episodes ranged between 1 and 8, with a mean (95% CI) severity of 7.3 (7.0; 7.6) at week 0 and 6.2 (5.8; 6.6) at week 4. Time to maximum pain intensity was 3-15 min in 52.2% of patients, and BTcP lasted 30-60 min in 14.4% of patients at week 0 and 4.4% of patients at week 4. Mean (95% CI) treatment effectiveness was 6.6 (6.1; 7.1) at week 0 and 7.4 (7.0; 7.8) at week 4. Median (Q1-Q3) patients' global impression of clinical condition was 4.0 (4.0-4.0) at week 0 and 3.0 (2.0-3.0) at week 4. A clear BTcP assessment and strict follow-up could be crucial to guidelines adherence and for patient's QoL.

Opioid analgesics for nociceptive cancer pain: Acomprehensive review.

Pain is one of the most burdensome symptoms in people with cancer, and opioid analgesics are considered the mainstay of cancer pain management. For this review, the authors evaluated the efficacy and toxicities of opioid analgesics compared with placebo, other opioids, nonopioid analgesics, and nonpharmacologic treatments for background cancer pain (continuous and relatively constant pain present at rest), and breakthrough cancer pain (transient exacerbation of pain despite stable and adequately controlled background pain). They found a paucity of placebo-controlled trials for background cancer pain, although tapentadol or codeine may be more efficacious than placebo (moderate-certainty to low-certainty evidence). Nonsteroidal anti-inflammatory drugs including aspirin, piroxicam, diclofenac, ketorolac, and the antidepressant medicine imipramine, may be at least as efficacious as opioids for moderate-to-severe background cancer pain. For breakthrough cancer pain, oral transmucosal, buccal, sublingual, or intranasal fentanyl preparations were identified as more efficacious than placebo but were more commonly associated with toxicities, including constipation and nausea. Despite being recommended worldwide for the treatment of cancer pain, morphine was generally not superior to other opioids, nor did it have a more favorable toxicity profile. The interpretation of study results, however, was complicated by the heterogeneity in the study populations evaluated. Given the limited quality and quantity of research, there is a need to reappraise the clinical utility of opioids in people with cancer pain, particularly those who are not at the end of life, and to further explore the effects of opioids on immune system function and quality of life in these individuals.

Fentanyl in cancer pain management: avoiding hasty judgments and discerning its potential benefits.

Cancer pain is an important challenge in treatment and requires a rapid onset of action for its control. In particular, breakthrough cancer pain (BTcP) should be adequately controlled with a stable dose of a short-acting oral opioid. Fentanyl is a synthetic, highly selective opioid with many advantageous chemical properties, including high lipophilicity and distinct pharmacokinetic properties. It is recommended for pain management in a variety of settings, including acute pain, chronic pain and BTcP. To date, its variously designed formulations allow non-invasive administration; amongst others, sublingual fentanyl has proven useful in the management of BTcP and in improving the quality of life of patients with cancer. This review provides an update on the management of BTcP with fentanyl, with consideration of safety, as it remains an important tool in the treatment of cancer pain.

Breakthrough and Episodic Cancer Pain from a Palliative Care Perspective.

Cancer pain intensity (PI) fluctuates, but the relationship between pain flares and background pain with respect to pain management is not settled. We studied how flare and background PIs corresponded with treatment results for background cancer pain. Patients admitted to an acute palliative care unit with average and/or worst PI ≥ 1 on the 11-point numeric rating scale were included. Average and worst PI at admission and average PI at discharge were collected. We examined how the difference and ratio between worst and average PI and average PI at admission, were associated with average PI development during hospitalization. Positive differences between worst and average PI at admission were defined as pain flares. Ninety out of 131 patients had pain flares. The reduction in average PI for patients with flares was 0.9 and for those without, 1.9 (p = 0.02). Patients with large worst minus average PI differences reported the least improvement, as did those with large worst/average PI ratios. Patients with pain flares and average PI ≤ 4 at admission had unchanged average PI during hospitalization, while those with pain flares and average PI > 4 experienced pain reduction (2.1, p < 0.001). Large pain flares, in absolute values and compared to background PI, were associated with inferior pain relief.

Pharmacokinetics, pharmacodynamics, and safety of LPM3480392 in two phase I clinical trials in healthy Chinese male subjects.

Drugs for acute postoperative pain and breakthrough cancer pain are still urgent on clinical. LPM3480392 is a G-protein-biased ligand at the μ-opioid receptor and showed potent analgesia in nonclinical studies. Two phase I studies of LPM3480392 were conducted in healthy Chinese male volunteers to explore its tolerability, pharmacokinetics, and pharmacodynamics under single ascending doses (Study I 0.1-3.0 mg, 30 min) and different infusion time (Study II, 0.6-1.0 mg, 2-15 min). There was one serious adverse event (AE) observed in Study II, and the rest AEs were mild or moderate in severity and resolved by the end of the study. Plasma LPM3480392 maximum concentration (Cmax ) (under lower infusion rate) and area under the plasma concentration-time curve (AUCs) were generally increased with dose. Moreover, LPM3480392 at dose of 0.6 mg under 2 min infusion rate elicited effective analgesia as the peak effect within 10-30 min, which measured by cold pain test and pupillometry. These findings suggest that LPM3480392 could be a potential treatment for acute pain management.

Knowledge and practice of the management of breakthrough cancer pain among general practitioners providing palliative care in Shanghai, China: a cross-sectional survey

ObjectiveThis study examined knowledge and practice of breakthrough cancer pain (BTcP) management among general practitioners (GPs) providing palliative care in Shanghai.DesignCross-sectional study using a self-administered questionnaire.Setting and participantsA total of...

Intrathecal Analgesia via a Percutaneous Port With Patient-Controlled Intrathecal Analgesia for the Management of Movement-Evoked Breakthrough Cancer Pain of Refractory Lower Extremity Cancer Pain: A Retrospective Review

BACKGROUND: Intrathecal analgesia (ITA) is a valuable treatment option for refractory cancer-related pain. However, there is still no general consensus on the analgesic effect of movement-evoked breakthrough pain (MEBTP) in the ITA setting. OBJECTIVES: This study aimed to conduct a retrospective observational study to examine the effect of ITA via percutaneous port (ITAPP) with patient-controlled ITA (PCIA) on analgesic efficacy, emphasizing MEBTP in patients with refractory lower extremity cancer pain. STUDY DESIGN: A retrospective chart review included all patients with refractory lower extremity cancer pain who received ITAPP at our hospital between January 2017 and December 2020. METHODS: Data on the Numeric Rating Scale scores of spontaneous resting pain intensity (SRPI) and MEBTP intensity (MEPI), opioid doses, and perceived time to onset were collected from medical records prior to ITAPP and at a one-month postimplant visit. RESULTS: A total of 16 patients were included in the study group. Mean SRPI decreased from 8.75 pre-ITAPP to 3.75 post-ITAPP (P &lt; 0.05); mean MEPI fell from 8.83 pre-ITAPP to 4.25 post-ITAPP (P &lt; 0.05); mean daily morphine equivalent dosing decreased from 360 mg/d to 48 mg/d (P &lt; 0.05); and mean daily morphine equivalent dosing for MEBTP decreased from 87 mg/d to 6 mg/d (P &lt; 0.05). Both total and breakthrough dosing of conventional opioid medications significantly decreased following the initiation of ITAPP with PCIA. The mean perceived time to onset with conventional MEBT medications was 38 minutes, and the mean perceived time to onset with PCIA was 8 minutes (P &lt; 0.05). LIMITATIONS: An effective analysis of IT opioid efficacy was not possible because the power of such a small sample size was low. Second, it is a retrospective study without long-term follow-ups. CONCLUSIONS: In patients with refractory lower extremity cancer pain, ITAPP with PCIA was associated with improved pain control. Compared with conventional MEBTP regimens, appropriate ITAPP with PCIA provided superior analgesia and a much faster onset of action. KEY WORDS: Movement-evoked breakthrough pain, patient-controlled intrathecal analgesia, lower extremity cancer pain, intrathecal analgesia via a percutaneous port

Validation of a French version of the Breakthrough Pain Assessment Tool in cancer patients: Factorial structure, reliability and responsiveness.

Breakthrough cancer pain should be properly assessed for better-personalized treatment plan. The Breakthrough Pain Assessment Tool is a 14-item tool validated in English developed for this purpose; no French version is currently available and validated. This study aimed to translate it in French and assess the psychometric properties of a French version of the Breakthrough Pain Assessment Tool (BAT-FR). First, translation and cross-cultural adaptation of the 14 items (9 ordinal and 5 nominal) of the original BAT tool in French language was made. Second, assessments of validity (convergent, divergent and discriminant validity), factorial structure (exploratory factor analysis) and test-retest reliability of the 9 ordinal items were done with data of 130 adult cancer patients suffering from breakthrough pain in a hospital-academic palliative care center. Test-retest reliability and responsiveness of total and dimension scores derived from these 9 items were also assessed. Acceptability of the 14 items was also assessed on the 130 patients. The 14 items had good content and face validity. Convergent and divergent validity, discriminant validity and test-retest reliability of the ordinal items were acceptable. Test-retest reliability and responsiveness of total and dimensions derived from ordinal items were also acceptable. The factorial structure of the ordinal items had two dimensions similar to the original version: "1-pain severity and impact" and "2-pain duration and medication". Items 2 and 8 had a low contribution to the dimension 1 they were assigned and item 14 clearly changed of dimension compared with the original tool. The acceptability of the 14 items was good. The BAT-FR has shown acceptable validity, reliability and responsiveness supporting its use for assessing breakthrough cancer pain in French-speaking populations. Its structure needs nevertheless further confirmation.

Utilizing an artificial intelligence framework (conditional generative adversarial network) to enhance telemedicine strategies for cancer pain management

BackgroundThe utilization of artificial intelligence (AI) in healthcare has significant potential to revolutionize the delivery of medical services, particularly in the field of telemedicine. In this article, we investigate the capabilities of a specific deep learning model, a generative adversarial network (GAN), and explore its potential for enhancing the telemedicine approach to cancer pain management.Materials and methodsWe implemented a structured dataset comprising demographic and clinical variables from 226 patients and 489 telemedicine visits for cancer pain management. The deep learning model, specifically a conditional GAN, was employed to generate synthetic samples that closely resemble real individuals in terms of their characteristics. Subsequently, four machine learning (ML) algorithms were used to assess the variables associated with a higher number of remote visits.ResultsThe generated dataset exhibits a distribution comparable to the reference dataset for all considered variables, including age, number of visits, tumor type, performance status, characteristics of metastasis, opioid dosage, and type of pain. Among the algorithms tested, random forest demonstrated the highest performance in predicting a higher number of remote visits, achieving an accuracy of 0.8 on the test data. The simulations based on ML indicated that individuals who are younger than 45 years old, and those experiencing breakthrough cancer pain, may require an increased number of telemedicine-based clinical evaluations.ConclusionAs the advancement of healthcare processes relies on scientific evidence, AI techniques such as GANs can play a vital role in bridging knowledge gaps and accelerating the integration of telemedicine into clinical practice. Nonetheless, it is crucial to carefully address the limitations of these approaches.