Malignant Tumor of Ill-defined SitePhase 2NCT02542397
LCI-NOS-PAIN-001: A Prospective, Pharmacogenomic-Driven Study of Pain Management in Oncology Outpatients
A Phase 2 study testing Pharmacogenomic Testing in people with Malignant Tumor of Ill-defined Site, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
About half of all cancer patients seen in oncology clinics have pain at initial assessment; pain relief within a one-month period is seen in approximately one third of these patients and pain worsening in about one fifth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Tumor of Ill-defined Site
- What is being tested?
- Pharmacogenomic Testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Jun 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of uncontrolled malignant pain (score of greater than or equal to 2 on an 11 point scale [0-10]) as diagnosed and assessed by the Investigator, using the Edmonton Symptom Assessment Scale (ESAS).
- Documentation of any stage of cancer of any tumor location (solid or hematological).
- At least 18 years of age.
- Either nociceptive or neuropathic pain.
- Able to understand and be willing to sign the study consent form.
Who cannot join
- Inpatient service at baseline visit.
- Significant dysphagia and inability to swallow oral medications as determined by the Investigator.
- Active or recent (within one year) drug and/or alcohol abuse as determined by the Investigator.
- Significant baseline cognitive impairment, as determined by the Investigator. Known (anaphylactic) hypersensitivity to any opioid.
- Severe oral mucositis that would impair proper buccal testing as determined by the Investigator.
- Receiving concurrent rehabilitation medicine care, nociception modulation (e.g., electrical stimulation), use of modalities with physiologic effects that indirectly influence nociception (e.g., light, laser therapy), or any other non-pharmacologic approaches to pain management other than exercise, rest, ice, compression, and elevation (RICE).
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- Presence of major psychiatric disorders as determined by the Investigator.
- Receiving active treatment or prophylaxis for epilepsy.
- Unable or unwilling to sign the study consent form.
Trial locations and contacts
1 site in 1 country.
United States1 site
Levine Cancer Institute
Charlotte, North Carolina, 28204
About this study
Official title: LCI-NOS-PAIN-001: A Prospective, Pharmacogenomic-Driven Pilot Study of Pain Management in Oncology Outpatients
About half of all cancer patients seen in oncology clinics have pain at initial assessment; pain relief within a one-month period is seen in approximately one third of these patients and pain worsening in about one fifth. Risk factors for under-treatment of cancer pain include age older than 65 years, minority status, and inadequate pain assessment practices. There is a need for better methods of opioid drug/dose selection and identification of risk factors for worsening pain. Pharmacogenomic approaches offer insight into the genetic variables that impact the pharmacokinetic and pharmacodynamic behavior of opioids. Translating pharmacogenomic results into actionable prescribing decisions may ultimately enable a personalized approach to pain management, increasing the chance of significant pain improvement. Cancer outpatients with uncontrolled malignant pain will be offered a pharmacogenomic test through participation in the study. The results of this test will be used to modify their pain regimen, if applicable.
Read the detailed description
All subjects will be assessed and prescribed a pain regimen as part of standard practice at the initial visit. Subjects will provide a buccal swab for pharmacogenomic testing and will be discharged on their initial pain regimen.
After the initial visit, subjects will be asked to rate their daily pain on a scale of 0-10. A coordinator will follow up with the subject within 7 days (Assessment #1). Subjects will be asked to report information about their pain scores, pain medication use, and caffeine intake, in addition to any bothersome symptoms. Subjects who continue to have "uncontrolled pain", are experiencing bothersome symptoms, and/or requests for a drug/dose modification will have his/her drug/dose modified using the pharmacogenomic test results. If the subject has had significant pain improvement, stable mild pain and/or is satisfied with their level of pain at the assessment (regardless of pain score), he/she will be recommended to continue the current drug/dose and return to clinic on day 30 for the final follow-up. Subjects will be told to call if their pain becomes intolerable or if they experience bothersome symptoms after Assessment #1 for further drug/dose modification if needed prior to day 30.
The coordinator will follow up with the subjects receiving a drug/dose modification after another 7 days (Assessment #2). Subjects who have now had significant pain improvement, stable mild pain, and/or are satisfied with their level pain at the assessment (regardless of pain score) will continue on the same regimen. If the subjects' pain is still "uncontrolled", they are experiencing bothersome symptoms, and/or they request a drug/dose modification, their drug/dose will be modified accordingly. Subjects will be told to call if needed, otherwise they will be seen in clinic on day 30 (Final Assessment).
If the subject experiences intolerable pain prior to any scheduled assessment, the subject will call for appropriate drug/dose modification.
- Conditions
- Malignant Tumor of Ill-defined Site
- Being tested
- Pharmacogenomic Testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacogenomic TestingGenetic
Pharmacogenomic test results to guide drug/dose modifications
| Study group | Role | What they receive |
|---|---|---|
| Pharmacogenomic Testing | Experimental | Pharmacogenomic test results to guide drug/dose modifications Receives: Genetic: Pharmacogenomic Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Pain Improvement as Measured Using the Edmonton Symptom Assessment Scale (ESAS) From Baseline Assessment (Day 0) to Final Assessment on Day 30 +/- 7
Proportion of subjects achieving significant pain improvement over a one month period (30 days +/- 7) (defined as a ≥ 2 point decrease from baseline pain score on an 11-point scale [0-10]) in oncology outpatients receiving pharmacogenomic testing.
Measured: Enrollment to Final Assessment (30 +/- 7 days from Baseline Assessment (Day 0))
Secondary outcomes (2)
Morphine Equivalent Daily Doses (MEDD) in Milligrams
Describe the distribution of morphine equivalent daily dose (MEDD) in the evaluable population. The MEDD was calculated and recorded at the Final Assessment for each subject by converting the subject's total daily opioid consumption at the Final Assessment to morphine equivalent doses using the following website: http://www.globalrph.com/narcoticonv.htm (widely used across many health systems for drug/dose conversions and fully referenced).
Measured: Final Assessment (30 +/- 7 days from Baseline Assessment (Day 0))
Percentage of Subjects With an Actionable Genotype, Defined as the Presence of Any Mutation(s) That is (Are) Used to Guide a Drug/Dose Modification
An actionable genotype is defined as the presence of at least one mutation that is used to guide a drug/dose modification during Assessment 1, Assessment 2, or any unscheduled visit.
Measured: Enrollment to Final Assessment (30 +/- 7 days from Baseline Assessment (Day 0))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionJun 2019
- Study completionJun 2019
Why it stopped: Early study closure due to limited internal resources to continue enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Tumor of Ill-defined SiteStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Enrolled subjects all receive pharmacogenomic testing with the intention of guiding pain management. This single-arm trial is testing against a published historical control.
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jai Patel, PharmD, Principal investigator, Atrium Health Levine Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02542397
- Sponsor's protocol ID
- LCI-NOS-PAIN-001
- Status last verified
- Mar 2021
- First submitted
- 2 Sep 2015
- Last updated
- 3 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Patel JN, Boselli D, Symanowski J, Wodarski S, Turner S, Slaughter C, Myers M, Edwards R, Susi B, Greiner R, Edelen C. Pilot study of multi-gene pharmacogenetic testing for pain management in oncology palliative medicine. Pharmacogenomics. 2021 Aug;22(12):737-748. doi: 10.2217/pgs-2021-0037. Epub 2021 Aug 20.
PubMed 34414777
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LCI-NOS-PAIN-001: A Prospective, Pharmacogenomic-Driven Pilot Study of Pain Management in Oncology Outpatients
- ClinicalTrials.gov ID
- NCT02542397
- Acronym / sponsor ID
- LCI-NOS-PAIN-001
- Conditions
- Malignant Tumor of Ill-defined Site
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early study closure due to limited internal resources to continue enrollment.
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 7 Sep 2015 (estimated)
- Results
- Posted 2 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
About half of all cancer patients seen in oncology clinics have pain at initial assessment; pain relief within a one-month period is seen in approximately one third of these patients and pain worsening in about one fifth. Risk factors for under-treatment of cancer pain include age older than 65 years, minority status, and inadequate pain assessment practices. There is a need for better methods of opioid drug/dose selection and identification of risk factors for worsening pain. Pharmacogenomic approaches offer insight into the genetic variables that impact the pharmacokinetic and pharmacodynamic behavior of opioids. Translating pharmacogenomic results into actionable prescribing decisions may ultimately enable a personalized approach to pain management, increasing the chance of significant pain improvement. Cancer outpatients with uncontrolled malignant pain will be offered a pharmacogenomic test through participation in the study. The results of this test will be used to modify their pain regimen, if applicable.
Detailed description
All subjects will be assessed and prescribed a pain regimen as part of standard practice at the initial visit. Subjects will provide a buccal swab for pharmacogenomic testing and will be discharged on their initial pain regimen.
After the initial visit, subjects will be asked to rate their daily pain on a scale of 0-10. A coordinator will follow up with the subject within 7 days (Assessment #1). Subjects will be asked to report information about their pain scores, pain medication use, and caffeine intake, in addition to any bothersome symptoms. Subjects who continue to have "uncontrolled pain", are experiencing bothersome symptoms, and/or requests for a drug/dose modification will have his/her drug/dose modified using the pharmacogenomic test results. If the subject has had significant pain improvement, stable mild pain and/or is satisfied with their level of pain at the assessment (regardless of pain score), he/she will be recommended to continue the current drug/dose and return to clinic on day 30 for the final follow-up. Subjects will be told to call if their pain becomes intolerable or if they experience bothersome symptoms after Assessment #1 for further drug/dose modification if needed prior to day 30.
The coordinator will follow up with the subjects receiving a drug/dose modification after another 7 days (Assessment #2). Subjects who have now had significant pain improvement, stable mild pain, and/or are satisfied with their level pain at the assessment (regardless of pain score) will continue on the same regimen. If the subjects' pain is still "uncontrolled", they are experiencing bothersome symptoms, and/or they request a drug/dose modification, their drug/dose will be modified accordingly. Subjects will be told to call if needed, otherwise they will be seen in clinic on day 30 (Final Assessment).
If the subject experiences intolerable pain prior to any scheduled assessment, the subject will call for appropriate drug/dose modification.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Enrolled subjects all receive pharmacogenomic testing with the intention of guiding pain management. This single-arm trial is testing against a published historical control.
| Arm | Type | Receives |
|---|---|---|
| Pharmacogenomic Testing | Experimental | Genetic: Pharmacogenomic TestingPharmacogenomic test results to guide drug/dose modifications |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Presence of uncontrolled malignant pain (score of greater than or equal to 2 on an 11 point scale [0-10]) as diagnosed and assessed by the Investigator, using the Edmonton Symptom Assessment Scale (ESAS).
- Documentation of any stage of cancer of any tumor location (solid or hematological).
- At least 18 years of age.
- Either nociceptive or neuropathic pain.
- Able to understand and be willing to sign the study consent form.
Key exclusion criteria (9 listed)
- Inpatient service at baseline visit.
- Significant dysphagia and inability to swallow oral medications as determined by the Investigator.
- Active or recent (within one year) drug and/or alcohol abuse as determined by the Investigator.
- Significant baseline cognitive impairment, as determined by the Investigator. Known (anaphylactic) hypersensitivity to any opioid.
- Severe oral mucositis that would impair proper buccal testing as determined by the Investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacogenomic TestingPharmacogenomic test results to guide drug/dose modifications | Genetic | Pharmacogenomic Testing |
Primary outcome
Rate of Pain Improvement as Measured Using the Edmonton Symptom Assessment Scale (ESAS) From Baseline Assessment (Day 0) to Final Assessment on Day 30 +/- 7
Time frame: Enrollment to Final Assessment (30 +/- 7 days from Baseline Assessment (Day 0))
Proportion of subjects achieving significant pain improvement over a one month period (30 days +/- 7) (defined as a ≥ 2 point decrease from baseline pain score on an 11-point scale [0-10]) in oncology outpatients receiving pharmacogenomic testing.
2 secondary outcomes
Morphine Equivalent Daily Doses (MEDD) in Milligrams
Time frame: Final Assessment (30 +/- 7 days from Baseline Assessment (Day 0))
Percentage of Subjects With an Actionable Genotype, Defined as the Presence of Any Mutation(s) That is (Are) Used to Guide a Drug/Dose Modification
Time frame: Enrollment to Final Assessment (30 +/- 7 days from Baseline Assessment (Day 0))
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34414777Patel JN, Boselli D, Symanowski J, Wodarski S, Turner S, Slaughter C, Myers M, Edwards R, Susi B, Greiner R, Edelen C. Pilot study of multi-gene pharmacogenetic testing for pain management in oncology palliative medicine. Pharmacogenomics. 2021 Aug;22(12):737-748. doi: 10.2217/pgs-2021-0037. Epub 2021 Aug 20.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jai Patel, PharmD principal investigator
Atrium Health Levine Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pharmacogenomic Testing in people with Malignant Tumor of Ill-defined Site, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Pain Improvement as Measured Using the Edmonton Symptom Assessment Scale (ESAS) From Baseline Assessment (Day 0) to Final Assessment on Day 30 +/- 7 (time frame: Enrollment to Final Assessment (30 +/- 7 days from Baseline Assessment (Day 0))). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02542397, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.