LCI-NOS-PAIN-001: A Prospective, Pharmacogenomic-Driven Study of Pain Management in Oncology Outpatients
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/23/2018 |
| Start Date: | September 2015 |
| End Date: | February 2019 |
| Contact: | Caitlin Olson |
| Email: | Caitlin.Olson@atriumhealth.org |
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.
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.
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.
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
- 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.
We found this trial at
1
site
Click here to add this to my saved trials
