Evidence map›Paper›PMID 29535047›Full record

ArticleContemporary clinical trials2018

Design and rational for the precision medicine guided treatment for cancer pain pragmatic clinical trial.

Scott A Mosley, J Kevin Hicks, Diane G Portman, Kristine A Donovan, Priya Gopalan, Jessica Schmit, Jason Starr, Natalie Silver, Yan Gong, Taimour Langaee and 9 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
2.7field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.

  1. Oxycodone for cancer-related pain.The Cochrane database of systematic reviews · 2022
    Pooled it
  2. Trial
  3. A hybrid implementation-effectiveness randomized trial of CYP2D6-guided postoperative pain management.Genetics in medicine : official journal of the American College of Medical Genetics · 2021
    Trial
  4. Article
  5. Personalized Medicine in Cancer Pain Management.Journal of personalized medicine · 2023
    Review
  6. Article
  7. Review
  8. Challenges and lessons learned from clinical pharmacogenetic implementation of multiple gene-drug pairs across ambulatory care settings.Genetics in medicine : official journal of the American College of Medical Genetics · 2019
    Article
  9. Review
  10. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 2 institutions in 1 country.

Scott A MosleyDepartment of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL, USA; Center for Pharmacogenomics, University of Florida, Gainesville, FL, USA.
J Kevin HicksDeBartolo Family Personalized Medicine Institute, Department of Individualized Cancer Management, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
Diane G PortmanDepartment of Supportive Care Medicine, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
Kristine A DonovanDepartment of Supportive Care Medicine, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
Priya GopalanDepartment of Medicine, College of Medicine, University of Florida, Gainesville, FL, USA.
Jessica SchmitDepartment of Medicine, College of Medicine, University of Florida, Gainesville, FL, USA.
Jason StarrDepartment of Medicine, College of Medicine, University of Florida, Gainesville, FL, USA.
Natalie SilverDepartment of Otolaryngology, College of Medicine, University of Florida, Gainesville, FL, USA.
Yan GongDepartment of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL, USA; Center for Pharmacogenomics, University of Florida, Gainesville, FL, USA.
Taimour LangaeeDepartment of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL, USA; Center for Pharmacogenomics, University of Florida, Gainesville, FL, USA.
Michael Clare-SalzlerDepartment of Medicine, College of Medicine, University of Florida, Gainesville, FL, USA; Department of Pathology, Immunology & Laboratory Medicine, College of Medicine, University of Florida, Gainesville, FL, USA.
Petr StarostikDepartment of Pathology, Immunology & Laboratory Medicine, College of Medicine, University of Florida, Gainesville, FL, USA.
Young D ChangDepartment of Supportive Care Medicine, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
Sahana RajasekharaDepartment of Supportive Care Medicine, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
Joshua E SmithDepartment of Supportive Care Medicine, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
Heloisa P SoaresDepartment of Gastrointestinal Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
Thomas J GeorgeDepartment of Medicine, College of Medicine, University of Florida, Gainesville, FL, USA.
Howard L McLeodDeBartolo Family Personalized Medicine Institute, Department of Individualized Cancer Management, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
Larisa H CavallariDepartment of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL, USA; Center for Pharmacogenomics, University of Florida, Gainesville, FL, USA; Clinical and Translational Science Institute, University of Florida, Gainesville, FL, USA. Electronic address: lcavallari@cop.ufl.edu.
University of Florida · USMoffitt Cancer Center · US

Funding

Sparking Advancements in Genomic MedicineU01HG007269 · NHGRI · UNIVERSITY OF FLORIDA · PI CAVALLARI, LARISA HUMMA, JOHNSON, JULIE A. · 2013 to 2024
$17.0M
NHGRI NIH HHS U01 HG007269
6 · The paper itself

Abstract

introductionPain is one of the most burdensome symptoms associated with cancer and its treatment, and opioids are the cornerstone of pain management. Opioid therapy is empirically selected, and patients often require adjustments in therapy to effectively alleviate pain or ameliorate adverse drug effects that interfere with quality of life. There are data suggesting CYP2D6 genotype may contribute to inter-patient variability in response to opioids through its effects on opioid metabolism. Therefore, we aim to determine if CYP2D6 genotype-guided opioid prescribing results in greater reductions in pain and symptom severity and interference with daily living compared to a conventional prescribing approach in patients with cancer.

methodsPatients with solid tumors with metastasis and a self-reported pain score ≥ 4/10 are eligible for enrollment and randomized to a genotype-guided or conventional pain management strategy. For patients in the genotype-guided arm, CYP2D6 genotype information is integrated into opioid prescribing decisions. Patients are asked to complete questionnaires regarding their pain, symptoms, and quality of life at baseline and 2, 4, 6, and 8 weeks after enrollment. The primary endpoint is differential change in pain severity by treatment strategy (genotype-guided versus conventional pain management). Secondary endpoints include change in pain and symptom interference with daily living.

conclusionPharmacogenetic-guided opioid selection for cancer pain management has potential clinical utility, but current evidence is limited to retrospective and observational studies. Precision Medicine Guided Treatment for Cancer Pain is a pragmatic clinical trial that seeks to determine the utility of CYP2D6 genotype-guided opioid prescribing in patients with cancer.

Indexed as

Analgesics, OpioidCancer PainNeoplasmsPain MeasurementCytochrome P-450 CYP2D6FemaleHumansMaleMiddle AgedNeoplasm MetastasisNeoplasm StagingPain ManagementPatient SelectionPharmacogeneticsPragmatic Clinical Trials as TopicPrecision MedicineAnalgesics, OpioidCytochrome P-450 CYP2D6CancerCYP2D6GenotypeOpioidOxycodonePainPatient reported outcomePharmacogeneticSymptomTrial design

Identifiers

PMID29535047
PMCPMC5899651
OpenAlexW2791573798

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.