Pilot study of multi-gene pharmacogenetic testing for pain management in oncology palliative medicine

2021 ◽  
Author(s):  
Jai N Patel ◽  
Danielle Boselli ◽  
James Symanowski ◽  
Stephanie Wodarski ◽  
ShRhonda Turner ◽  
...  
Keyword(s):  
Palliative Medicine ◽  
Pilot Trial ◽  
Final Visit ◽  
Test Results ◽  
Pharmacogenetic Testing ◽  
Point Reduction ◽  
Gene Testing ◽  
Pain Scores ◽  
Pharmacogenetic Test ◽  
Pain Improvement

Aim: We evaluated the application and clinical impact of multi-gene pharmacogenetic testing in oncology palliative medicine. Patients & Methods: In a single-arm pilot trial, cancer patients with uncontrolled pain were assessed in a palliative medicine clinic at baseline and received pharmacogenetic testing. Results were used as applicable up to the final visit (day 30). Pain scores, opioid prescribing, and use of pharmacogenetic test results were collected. Results: In 75 patients, the median baseline pain score was 7/10. Of 54 evaluable at the final visit, 28 required opioid modifications and 19 had actionable genotypes, mostly CYP2D6. Pain improvement (≥2-point reduction) was higher than historical data (56 vs 30%; p < 0.001). There were no differences in pain improvement between those with and without actionable genotypes (61 vs 53%). Conclusion: Multi-gene testing identified actionable genotypes and may improve cancer pain.

Acupuncture for Cancer Pain and Symptom Management in a Palliative Medicine Clinic

2018 ◽  
Vol 36 (4) ◽  
pp. 326-332 ◽  
Author(s):  
Katherine R. Miller ◽  
Jai N. Patel ◽  
James T. Symanowski ◽  
Connie A. Edelen ◽  
Declan Walsh
Keyword(s):  
Palliative Medicine ◽  
Multivariable Analysis ◽  
Retrospective Chart Review ◽  
Patient Characteristics ◽  
Well Being ◽  
Pain Reduction ◽  
Pain Response ◽  
Point Reduction ◽  
Pain Scores ◽  
Pain Improvement

Objective: Studies suggest acupuncture improves cancer-related symptoms; however, it is unclear whether patient characteristics predict pain response. This study determined acupuncture’s effect on cancer-related pain and identified variables associated with pain response. Methods: A retrospective chart review included adult patients with cancer referred to palliative medicine and received acupuncture for pain management. Paired t tests compared differences in pain scores from pre- to postacupuncture. Clinically meaningful pain improvement was defined as ≥2-point reduction in pain score. Logistic regression was used to evaluate associations between patient characteristics and pain improvement. Results: One hundred seventy acupuncture treatments from 68 individual patients were studied. Significant reductions in mean pain scores were observed after the first treatment (−1.9 ± 1.8; P < .001) and across all treatments (−1.7 ± 1.9; P < .001). Multivariable analysis demonstrated clinically meaningful pain improvement with higher baseline pain scores (odds ratio [OR]: 1.79, 95% confidence interval [CI]: 1.44-2.22; P < .001) and stage III/IV disease (OR: 3.23, 95% CI: 1.11-9.40; P < .001). There were significant improvements in anxiety, depression, drowsiness, dyspnea, fatigue, nausea, and well-being after the first treatment and across all treatments ( P < .001). Conclusions: Acupuncture improved cancer-related pain and other symptoms. Those with higher baseline pain scores and advanced disease were more likely to achieve significant pain reduction. Improved depression and fatigue were closely related to pain reduction. Further studies are needed to confirm pain response variables, establish durability, and develop a personalized approach to acupuncture.

Pain Management Using Clinical Pharmacy Assessments With and Without Pharmacogenomics in an Oncology Palliative Medicine Clinic

2020 ◽  
Vol 16 (2) ◽  
pp. e166-e174 ◽  
Author(s):  
Jai N. Patel ◽  
Danielle Boselli ◽  
Issam S. Hamadeh ◽  
James Symanowski ◽  
Rebecca Edwards ◽  
...  
Keyword(s):  
Pain Management ◽  
Palliative Medicine ◽  
Performance Status ◽  
Historical Control ◽  
Final Visit ◽  
Fisher Exact Test ◽  
Improvement Rate ◽  
Patients With Cancer ◽  
Edmonton Symptom Assessment Scale ◽  
Pain Improvement

PURPOSE: Approximately 30% of patients with cancer who have pain have symptomatic improvement within 1 month using conventional pain management strategies. Engaging clinical pharmacists in palliative medicine (PM) and use of pharmacogenomic testing may improve cancer pain management. METHODS: Adult patients with cancer with uncontrolled pain had baseline assessments performed by PM providers using the Edmonton Symptom Assessment Scale. Pharmacotherapy was initiated or modified accordingly. A subset of patients consented to pharmacogenomic testing. The first pharmacy assessment occurred within 1 week of baseline and a second assessment was done within another week if intervention was required. Each patient’s final visit was at 1 month. Pain improvement rate (a reduction of two or more points on a 0-to-10 pain scale) from baseline to final visit was compared applying the Fisher exact test to published historical control data, and between patients with and without pharmacogenomic testing. Multivariate logistic regression identified pain improvement covariates. RESULTS: Of 142 patients undergoing pharmacy assessments, 53% had pain improvement compared with 30% in historical control subjects ( P < .001). Pain improvement was not different between those who received (n = 43) and did not receive (n = 99) pharmacogenomics testing (56% v 52%; P = .716). However, of 15 patients with an actionable genotype, 73% had pain improvement. Higher baseline pain (odds ratio [OR], 1.79; 95% CI, 1.43 to 2.24; P < .001), black or other race (OR, 0.42; 95% CI, 0.18 to 0.95; P = .04), and performance status 3 or 4 (OR, 0.18; 95% CI, 0.04 to 0.83; P = .03) were associated with odds of pain improvement, but pharmacogenomic testing was not ( P = .64). CONCLUSION: Including pharmacists in PM improves pain management effectiveness. Although pharmacogenomics did not statistically improve pain, a subset of patients with actionable genotypes may have benefited, warranting larger and randomized studies.

Pharmacogenetic (PGx) guided cancer pain management in an oncology palliative medicine (PM) clinic.

2019 ◽  
Vol 37 (31_suppl) ◽  
pp. 117-117
Author(s):  
Jai Narendra Patel ◽  
Danielle Boselli ◽  
James Thomas Symanowski ◽  
Stephanie Wodarski ◽  
ShRhonda Turner ◽  
...  
Keyword(s):  
Pain Management ◽  
Cancer Pain ◽  
Pilot Trial ◽  
Final Visit ◽  
Buccal Swab ◽  
Nucleotide Polymorphisms ◽  
Cancer Pain Management ◽  
Improvement Rate ◽  
Edmonton Symptom Assessment Scale ◽  
Pain Improvement

117 Background: About 30% of cancer patients presenting with pain have symptomatic improvement using conventional strategies within one month. PGx may help personalize opioid selection and improve cancer pain management. Methods: This is a pragmatic pilot trial investigating the feasibility and application of PGx testing to improve pain management in adults with uncontrolled cancer pain referred to an oncology PM clinic. PM providers assessed patients using Edmonton Symptom Assessment Scale at baseline and opioid therapy was initiated or modified. A buccal swab was obtained for genotyping single nucleotide polymorphisms in: COMT, CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A4, CYP3A5, and OPRM1. The first assessment occurred within one week of baseline and a second within another week if intervention was required. PGx results were available before the first assessment and utilized, if applicable, throughout the one-month study period. Pain improvement rate (≥ 2-point reduction on a 0-10 scale) from baseline to final visit, was compared to historical control data by a one-sided exact binomial test of proportions. Results: Of 75 undergoing PGx testing, 52 were evaluable for the primary endpoint (54% female, 81% white, 17% black, median age 63, 75% stage 3 or 4 disease, median personalized pain goal 3 [0-6]). 56% had pain improvement compared to 30% in historical controls (p < 0.001). At final assessment, 35% met their personalized pain goal. Of 26 (50%) requiring opioid adjustments, 18 (69%) had an actionable genotype with a 61% pain improvement rate. The two most common genes for opioid adjustment were CYP2D6 (16/18; 89%) and COMT (8/18; 44%). The most common PGx-guided modification involved switching from a CYP2D6-metabolized drug (hydrocodone, oxycodone, tramadol) to a non-CYP2D6-metabolized drug (fentanyl, hydromorphone, methadone, morphine). Conclusions: PGx implementation in an oncology PM clinic was feasible and improved pain management. Half of those requiring opioid adjustments had an actionable genotype, with the largest impact from CYP2D6 polymorphisms. Future studies should focus on preemptive PGx testing to guide initial drug selection and confirm clinical utility in a randomized trial. Clinical trial information: NCT02542397.

Pilot, open non-controlled trial to assess the feasibility of implementing objective parameters as primary endpoints in a clinical trial with patients affected by knee osteoarthritis. (Preprint)

2019 ◽  
Author(s):  
Bogdan Corneliu Andor ◽  
Dionisio Franco Barattini ◽  
Dumitru Emanuel Dogaru ◽  
Simone Guadagna ◽  
Serban Rosu
Keyword(s):  
Chondroitin Sulphate ◽  
Controlled Trial ◽  
Subjective Evaluation ◽  
Pilot Trial ◽  
Final Visit ◽  
Life Questionnaire ◽  
Quality Of Data ◽  
Open Label ◽  
Objective Measurements

BACKGROUND Osteoarthritis (OA) is one of the top five most disabling conditions and it affects more than one third of persons over 65 years of age. Currently 80% of persons affected by OA already report having some movement limitation, 20% of people are not be able to perform major activities of daily living, and about 11% of the total affected population need of personal care. On 2014 the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) suggested as first step of pharmacological treatment for knee OA a background therapy with chronic symptomatic slow-acting drugs for osteoarthritis (SYSADOAs), such as glucosamine sulphate, chondroitin sulphate and hyaluronic acid (HA). In studies with oral HA, symptoms of OA are often measured using subjective parameters such as the visual analog scale (VAS) or the quality of life questionnaire (QoL) and objective measurements as ultrasonography (US) or range of motion (ROM) are employed in very few trials. This affects the quality of data in the literature. OBJECTIVE The primary objective of this work is to assess the feasibility of implementing US and ROM as objective measurements to correlate the improvement of knee mobility with pain reduction, evaluated using a subjective scale (VAS) in patients assuming a nutraceutical containing HA. The secondary objective is to evaluate the enrollment rate in one month to verify the feasibility for time and budget of the planned future main study. The explorative objective of the trial is to obtain preliminary data on efficacy of the tested product. METHODS This open-label pilot trial is performed in an orthopedic clinic (Timisoara, Romania). Male and female subjects (from 50 to 70 years) diagnosed with symptomatic OA of the knee with mild joint discomfort for at least 6 months are included. Following protocol, 8 patients are administered for 8 weeks Syalox® 300 Plus (River Pharma, Italy), a product based on HA of high molecular weight. Baseline and final visit assessments include orthopedic assessment, US, Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire, VAS and ROM of knee. RESULTS Data collection occurred between February 2018 and June 2018. All results are expected to be available by the end of 2018. CONCLUSIONS This pilot trial will be the first study to analyze the potential correlation between subjective evaluation (VAS, KOOS questionnaire) and objective measurements (US, ROM and actigraphy). The data from this study will assess the feasibility of the planned monthly recruitment rate and the necessary time and budget, and should provide preliminary information on efficacy of the tested product. CLINICALTRIAL ClinicalTrials.gov (NCT number: NCT03421054).

scholarly journals EUS-Guided Versus Percutaneous Celiac Neurolysis for the Management of Intractable Pain Due to Unresectable Pancreatic Cancer: A Randomized Clinical Trial

2020 ◽  
Vol 9 (6) ◽  
pp. 1666
Author(s):  
Won Jae Yoon ◽  
Yul Oh ◽  
Changhoon Yoo ◽  
Sunguk Jang ◽  
Seong-Sik Cho ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Abdominal Pain ◽  
Back Pain ◽  
Cancer Patients ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Intractable Pain ◽  
Point Reduction ◽  
Pain Scores ◽  
Numerical Rating

Although endoscopic ultrasound-guided celiac neurolysis (EUS-CN) and percutaneous celiac neurolysis (PCN) are utilized to manage intractable pain in pancreatic cancer patients, no direct comparison has been made between the two methods. We compared the efficacy and safety of EUS-CN and PCN in managing intractable pain in such patients. Sixty pancreatic cancer patients with intractable pain were randomly assigned to EUS-CN (n = 30) or PCN (n = 30). The primary outcomes were pain reduction in numerical rating scale (NRS) and opioid requirement reduction. Secondary outcomes were: successful pain response (NRS decrease ≥50% or ≥3-point reduction from baseline); quality of life; patient satisfaction; adverse events; and survival rate at 3 months postintervention. Both groups reported sustained decreases in pain scores up to 3 months postintervention (mean reductions in abdominal pain: 0.9 (95% confidence interval (CI): −0.8 to 4.2) and 1.7 (95% CI: −0.3 to 2.1); back pain: 1.3 (95% CI: −0.9 to 3.4) and 2.5 (95% CI: −0.2 to 5.2) in EUS-CN, and PCN groups, respectively). The differences in mean pain scores between the two groups at baseline and 3 months were −0.5 (p = 0.46) and −1.4 (p = 0.11) for abdominal pain and 0.1 (p = 0.85) and −0.9 (p = 0.31) for back pain in favor of PCN. No significant differences were noted in opioid requirement reduction and other outcomes. EUS-CN and PCN were similarly effective and safe in managing intractable pain in pancreatic cancer patients. Either methods may be used depending on the resources and expertise of each institution.

scholarly journals Substantial Reduction in Adjuvant Chemotherapy With the Use of the 21-Gene Test to Manage Early Breast Cancer in a Public Hospital in Brazil

2021 ◽  
pp. 1003-1011
Author(s):  
André Mattar ◽  
Guilherme R. Fonseca ◽  
Murilo B. A. Romão ◽  
Jorge Y. Shida ◽  
Vilmar M. de Oliveira ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Substantial Reduction ◽  
Recurrence Score ◽  
Treatment Recommendations ◽  
Public Hospitals ◽  
Test Results ◽  
Node Positive ◽  
Gene Testing ◽  
Gene Test ◽  
The Impact

PURPOSE We evaluated the impact of 21-gene test results on treatment decisions for patients with early-stage breast cancer treated under the public health care system in Brazil, Sistema Único de Saúde. METHODS Eligible patients treated at Hospital Pérola Byington and Santa Casa de Misericórdia de São Paulo in Brazil were required to have the following characteristics: postsurgery with hormone receptor–positive, human epidermal growth factor 2–negative, node-negative and node-positive, and T1/T2 breast cancer and patients with these characteristics were candidates for adjuvant systemic therapy. Treatment recommendations, chemotherapy plus hormonal therapy (CT + HT) or HT alone, were captured before and after 21-gene test results. RESULTS From August 2018 to April 2019, 179 women were enrolled. The mean age was 58 years (29-86 years), 135 (76%) were postmenopausal, and 58 (32%) had node-positive breast cancer. Most patients (61%) had a tumor > 2 cm, including 7% with tumors > 4 cm. Using Recurrence Score (RS) result cut points on the basis of the TAILORx trial, 40 (22%) had RS 0-10, 91 (51%) had RS 11-25, and 48 (27%) had RS 26-100. Before 21-gene testing, 162 of 179 (91%) patients were recommended for CT. After testing, 117 of 179 patients (65%) had changes in CT recommendation: 112 (63%) who were initially recommended CT received HT alone and five (3%) who were initially recommended HT alone received CT + HT. After 21-gene testing, 99% of physicians reported strong confidence in their treatment recommendations. CONCLUSION The change in clinical practice at these public hospitals was greater than expected: 66% of initial treatment recommendations were changed to omit CT with 21-gene test results. Clinicopathologic features did not correlate well with 21-gene test results and did not adequately identify those most likely to benefit from CT.

Oral vitamin B12 to improve aromatase inhibitors (AI)-associated musculoskeletal symptoms (AIMSS).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e21679-e21679
Author(s):  
Aleli Campbell ◽  
Zeina A. Nahleh ◽  
Rosalinda Heydarian ◽  
Cecilia Ochoa ◽  
Alok Dwivedi
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Vitamin B12 ◽  
Joint Pain ◽  
Musculoskeletal Symptoms ◽  
P Value ◽  
Pain Scores ◽  
End Of Treatment ◽  
Pain Improvement

e21679 Background: Breast cancer patients undergoing Aromatase Inhibitor (AI) therapy often experience many side effects, which include musculoskeletal and joint pain. Vitamin B12 has often been used as a naturopathic supplement to relieve joint pain that is caused by arthritis. The purpose of this study was to evaluate the effect of Vitamin B12 supplements on musculoskeletal pain and arthralgias induced by aromatase inhibitors (AI) therapy. Methods: After approval by Institutional Review Board (IRB), we enrolled consecutive patients treated at the Texas Tech Breast Care Center who had a diagnosis of invasive breast cancer, Stages I-III, and were taking an AI and experiencing significant musculoskeletal symptoms assessed by the Brief Pain Inventory-Short Form (BPI-SF) questionnaire. Participants received 2500 mcg of sublingual vitamin B12 daily for 90 days. Assessments included improvement in BPI-SF pain scores at 3 months, the impact on quality of life determined by the Functional Assessment of Cancer Therapy–Endocrine Symptoms, FACT-ES and correlative serum markers. Results: A total of forty-one patients were enrolled, five patients withdrew, leaving thirty-six patients to complete the study. Analysis of the data collected indicate a 34% average pain improvement (P-value = 0.0001) as reported by patients at baseline and at the end of treatment in the BPI-SF questionnaire. Additionally, a 23 % worst pain improvement (P-value = 0.0003) was obtained for worst pain scores evaluated similarly, at baseline and at the end of treatment. Analysis of the results for the FACT-ES scoring showed improvement on all scales. No significant adverse events were observed. Additionally, decrease in pain score was correlated with increased serum B12 levels. A paired t-test was used to assess the mean difference between baseline and endpoint. Conclusions: This study suggests that vitamin B12 reduces pain and improves quality of life for patients taking AIs who experienced AI-related musculoskeletal symptoms. If confirmed in large randomized prospective trials, Vitamin B12 would be a safe and cost effective option for the treatment of AI -related musculoskeletal symptoms.

scholarly journals How to Treat Chronic Idiopathic Testicular Pain? Scrotoscopy with a Novel Percutaneous Endoscopy Equipment

2018 ◽  
Vol 2018 ◽  
pp. 1-8 ◽  
Author(s):  
Junhao Lei ◽  
Chunhua Luo ◽  
Xinjun Su ◽  
Xinghuan Wang
Keyword(s):  
Adverse Event ◽  
Operating Time ◽  
The Novel ◽  
Wound Infections ◽  
Testicular Pain ◽  
Pain Scores ◽  
Inflammatory Changes ◽  
Pain Improvement ◽  
Percutaneous Endoscopy

Background. Management of chronic idiopathic testicular pain may be difficult because of problems identifying the causes. We evaluated “AUTOKLAV”, a novel endourological nephrolithotomy device to diagnose and treat chronic idiopathic testicular pain. Methods. We divided 103 patients to either scrotoscopy group (SG, n = 64) or open exploration group (OEG, n = 39) between September 2014 and March 2017 at Zhongnan Hospital. Perioperative information, like operating time, length of incision, and wound infections, was carefully recorded during in hospital. Follow-up data, like pain scores improvement, satisfaction with penis appearance, and adverse event, were collected at one month postoperatively. Results. Finally, both the operating time and length of incision showed better performance for SG (43.6 ± 4.7 versus 51.5 ± 9.0 min; 0.7 ± 0.2 versus 4.1 ± 0.8 cm; both P <0.01). Though the pain improvement had no significant differences between the two groups (2.92 ± 0.99 and 2.14 ± 1.02, p>0.05), SG showed obvious advantages in incidence of wound infections and satisfaction with wound/scrotum appearance (0% versus 2.9%; 96.4% versus 85.3%, both P<0.05). Conclusions. In conclusion, scrotoscopy using the novel AUTOKLAV device is feasible, has an acceptable complication rate, and can be effective and safe in men with idiopathic chronic testicular pain. Etiologically, secondary inflammatory changes caused by the complete or incomplete torsion of testicular or epididymis appendices or by the existence of stones in the tunica sac might be responsible for the pain.

scholarly journals Standardizing terms for clinical pharmacogenetic test results: consensus terms from the Clinical Pharmacogenetics Implementation Consortium (CPIC)

2016 ◽  
Vol 19 (2) ◽  
pp. 215-223 ◽  
Author(s):  
Kelly E. Caudle ◽  
Henry M. Dunnenberger ◽  
Robert R. Freimuth ◽  
Josh F. Peterson ◽  
Jonathan D. Burlison ◽  
...  
Keyword(s):  
Test Results ◽  
Pharmacogenetic Test
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