Trial Outcomes & Findings for LCI-NOS-PAIN-001: A Prospective, Pharmacogenomic-Driven Study of Pain Management in Oncology Outpatients (NCT NCT02542397)

Last Updated: 2022-11-03

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

75 participants

Primary outcome timeframe

Enrollment to Final Assessment (30 +/- 7 days from Baseline Assessment (Day 0))

Results posted on

2022-11-03

Participant Flow

Participant milestones

Participant milestones
Measure	Pharmacogenomic Testing Cancer outpatients with uncontrolled malignant pain undergo a pharmacogenomic panel (by buccal swab) with the intent of informing pain management.
Overall Study STARTED	75
Overall Study COMPLETED	59
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Pharmacogenomic Testing Cancer outpatients with uncontrolled malignant pain undergo a pharmacogenomic panel (by buccal swab) with the intent of informing pain management.
Overall Study Death	2
Overall Study Physician Decision	6
Overall Study Withdrawal by Subject	6
Overall Study Lost to Follow-up	2

Baseline Characteristics

LCI-NOS-PAIN-001: A Prospective, Pharmacogenomic-Driven Study of Pain Management in Oncology Outpatients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pharmacogenomic Testing n=75 Participants Cancer outpatients with uncontrolled malignant pain undergo a pharmacogenomic panel (by buccal swab) with the intent of informing pain management.
Age, Continuous	61 years n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants
Race (NIH/OMB) White	58 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Cancer type Breast	14 Participants n=5 Participants
Cancer type Gastrointestinal	12 Participants n=5 Participants
Cancer type Gynecologic	8 Participants n=5 Participants
Cancer type Multiple Myeloma	11 Participants n=5 Participants
Cancer type Thoracic	10 Participants n=5 Participants
Cancer type Genitourinary	5 Participants n=5 Participants
Cancer type Cutaneous malignancies	6 Participants n=5 Participants
Cancer type Other	9 Participants n=5 Participants
Stage of cancer (as captured from the Medical Record and determined by the TNM system of the AJCC) 1 or 2	13 Participants n=5 Participants
Stage of cancer (as captured from the Medical Record and determined by the TNM system of the AJCC) 3 or 4	57 Participants n=5 Participants
Stage of cancer (as captured from the Medical Record and determined by the TNM system of the AJCC) Other	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Enrollment to Final Assessment (30 +/- 7 days from Baseline Assessment (Day 0))

Population: The evaluable population is defined as those enrolled subjects providing pain scores at Baseline Assessment (Day 0) and Final Assessment (Day 30 +/- 7).

Outcome measures

Outcome measures
Measure	Pharmacogenomic Testing: Evaluable Population n=54 Participants Enrolled subjects providing pain scores at Baseline Assessment (Day 0) and Final Assessment (Day 30 +/- 7).
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	.5556 proportion of evaluable participants Interval 0.414 to 0.6908

SECONDARY outcome

Timeframe: Final Assessment (30 +/- 7 days from Baseline Assessment (Day 0))

Population: The evaluable population is defined as those enrolled subjects providing pain scores at Baseline Assessment (Day 0) and Final Assessment (Day 30 +/- 7).

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).

Outcome measures

Outcome measures
Measure	Pharmacogenomic Testing: Evaluable Population n=54 Participants Enrolled subjects providing pain scores at Baseline Assessment (Day 0) and Final Assessment (Day 30 +/- 7).
Morphine Equivalent Daily Doses (MEDD) in Milligrams	90 milligrams Interval 0.0 to 789.0

SECONDARY outcome

Timeframe: Enrollment to Final Assessment (30 +/- 7 days from Baseline Assessment (Day 0))

Population: The evaluable population is defined as those enrolled subjects providing pain scores at Baseline Assessment (Day 0) and Final Assessment (Day 30 +/- 7).

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.

Outcome measures

Outcome measures
Measure	Pharmacogenomic Testing: Evaluable Population n=54 Participants Enrolled subjects providing pain scores at Baseline Assessment (Day 0) and Final Assessment (Day 30 +/- 7).
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	33.33 percentage of evaluable participants Interval 21.09 to 47.47

Adverse Events

Pharmacogenomic Testing

Serious events: 2 serious events

Other events: 34 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Pharmacogenomic Testing n=75 participants at risk Cancer outpatients with uncontrolled malignant pain undergo a pharmacogenomic panel (by buccal swab) with the intent of informing pain management.
General disorders Death NOS	2.7% 2/75 • Number of events 2 • From enrollment date (i.e., buccal swab is collected) (Day 0) to the final study assessment on Day 30 +/- 7. Opioid-related adverse events were summarized and attributed based on Common Terminology Criteria for Adverse Events version 4.03. Adverse events deemed "possibly", "probably", and "definitely related" to opioid use by the Investigator were summarized for the study.

Other adverse events

Other adverse events
Measure	Pharmacogenomic Testing n=75 participants at risk Cancer outpatients with uncontrolled malignant pain undergo a pharmacogenomic panel (by buccal swab) with the intent of informing pain management.
Nervous system disorders Cognitive disturbance	1.3% 1/75 • Number of events 1 • From enrollment date (i.e., buccal swab is collected) (Day 0) to the final study assessment on Day 30 +/- 7. Opioid-related adverse events were summarized and attributed based on Common Terminology Criteria for Adverse Events version 4.03. Adverse events deemed "possibly", "probably", and "definitely related" to opioid use by the Investigator were summarized for the study.
Nervous system disorders Concentration impairment	1.3% 1/75 • Number of events 3 • From enrollment date (i.e., buccal swab is collected) (Day 0) to the final study assessment on Day 30 +/- 7. Opioid-related adverse events were summarized and attributed based on Common Terminology Criteria for Adverse Events version 4.03. Adverse events deemed "possibly", "probably", and "definitely related" to opioid use by the Investigator were summarized for the study.
Psychiatric disorders Confusion	8.0% 6/75 • Number of events 6 • From enrollment date (i.e., buccal swab is collected) (Day 0) to the final study assessment on Day 30 +/- 7. Opioid-related adverse events were summarized and attributed based on Common Terminology Criteria for Adverse Events version 4.03. Adverse events deemed "possibly", "probably", and "definitely related" to opioid use by the Investigator were summarized for the study.
Gastrointestinal disorders Constipation	9.3% 7/75 • Number of events 8 • From enrollment date (i.e., buccal swab is collected) (Day 0) to the final study assessment on Day 30 +/- 7. Opioid-related adverse events were summarized and attributed based on Common Terminology Criteria for Adverse Events version 4.03. Adverse events deemed "possibly", "probably", and "definitely related" to opioid use by the Investigator were summarized for the study.
Psychiatric disorders Delirium	2.7% 2/75 • Number of events 2 • From enrollment date (i.e., buccal swab is collected) (Day 0) to the final study assessment on Day 30 +/- 7. Opioid-related adverse events were summarized and attributed based on Common Terminology Criteria for Adverse Events version 4.03. Adverse events deemed "possibly", "probably", and "definitely related" to opioid use by the Investigator were summarized for the study.
Nervous system disorders Dizziness	8.0% 6/75 • Number of events 6 • From enrollment date (i.e., buccal swab is collected) (Day 0) to the final study assessment on Day 30 +/- 7. Opioid-related adverse events were summarized and attributed based on Common Terminology Criteria for Adverse Events version 4.03. Adverse events deemed "possibly", "probably", and "definitely related" to opioid use by the Investigator were summarized for the study.
Gastrointestinal disorders Dry mouth	1.3% 1/75 • Number of events 1 • From enrollment date (i.e., buccal swab is collected) (Day 0) to the final study assessment on Day 30 +/- 7. Opioid-related adverse events were summarized and attributed based on Common Terminology Criteria for Adverse Events version 4.03. Adverse events deemed "possibly", "probably", and "definitely related" to opioid use by the Investigator were summarized for the study.
Injury, poisoning and procedural complications Fall	4.0% 3/75 • Number of events 3 • From enrollment date (i.e., buccal swab is collected) (Day 0) to the final study assessment on Day 30 +/- 7. Opioid-related adverse events were summarized and attributed based on Common Terminology Criteria for Adverse Events version 4.03. Adverse events deemed "possibly", "probably", and "definitely related" to opioid use by the Investigator were summarized for the study.
General disorders Fatigue	9.3% 7/75 • Number of events 9 • From enrollment date (i.e., buccal swab is collected) (Day 0) to the final study assessment on Day 30 +/- 7. Opioid-related adverse events were summarized and attributed based on Common Terminology Criteria for Adverse Events version 4.03. Adverse events deemed "possibly", "probably", and "definitely related" to opioid use by the Investigator were summarized for the study.
General disorders Gait disturbance	1.3% 1/75 • Number of events 1 • From enrollment date (i.e., buccal swab is collected) (Day 0) to the final study assessment on Day 30 +/- 7. Opioid-related adverse events were summarized and attributed based on Common Terminology Criteria for Adverse Events version 4.03. Adverse events deemed "possibly", "probably", and "definitely related" to opioid use by the Investigator were summarized for the study.
Gastrointestinal disorders Gastroesophageal reflux disease	1.3% 1/75 • Number of events 1 • From enrollment date (i.e., buccal swab is collected) (Day 0) to the final study assessment on Day 30 +/- 7. Opioid-related adverse events were summarized and attributed based on Common Terminology Criteria for Adverse Events version 4.03. Adverse events deemed "possibly", "probably", and "definitely related" to opioid use by the Investigator were summarized for the study.
General disorders General disorders and administration site conditions - Other, Weakness in joints	1.3% 1/75 • Number of events 1 • From enrollment date (i.e., buccal swab is collected) (Day 0) to the final study assessment on Day 30 +/- 7. Opioid-related adverse events were summarized and attributed based on Common Terminology Criteria for Adverse Events version 4.03. Adverse events deemed "possibly", "probably", and "definitely related" to opioid use by the Investigator were summarized for the study.
Psychiatric disorders Hallucinations	2.7% 2/75 • Number of events 2 • From enrollment date (i.e., buccal swab is collected) (Day 0) to the final study assessment on Day 30 +/- 7. Opioid-related adverse events were summarized and attributed based on Common Terminology Criteria for Adverse Events version 4.03. Adverse events deemed "possibly", "probably", and "definitely related" to opioid use by the Investigator were summarized for the study.
Nervous system disorders Headache	2.7% 2/75 • Number of events 3 • From enrollment date (i.e., buccal swab is collected) (Day 0) to the final study assessment on Day 30 +/- 7. Opioid-related adverse events were summarized and attributed based on Common Terminology Criteria for Adverse Events version 4.03. Adverse events deemed "possibly", "probably", and "definitely related" to opioid use by the Investigator were summarized for the study.
Nervous system disorders Hypersomnia	1.3% 1/75 • Number of events 1 • From enrollment date (i.e., buccal swab is collected) (Day 0) to the final study assessment on Day 30 +/- 7. Opioid-related adverse events were summarized and attributed based on Common Terminology Criteria for Adverse Events version 4.03. Adverse events deemed "possibly", "probably", and "definitely related" to opioid use by the Investigator were summarized for the study.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, Chin laceration	1.3% 1/75 • Number of events 1 • From enrollment date (i.e., buccal swab is collected) (Day 0) to the final study assessment on Day 30 +/- 7. Opioid-related adverse events were summarized and attributed based on Common Terminology Criteria for Adverse Events version 4.03. Adverse events deemed "possibly", "probably", and "definitely related" to opioid use by the Investigator were summarized for the study.
Gastrointestinal disorders Nausea	17.3% 13/75 • Number of events 14 • From enrollment date (i.e., buccal swab is collected) (Day 0) to the final study assessment on Day 30 +/- 7. Opioid-related adverse events were summarized and attributed based on Common Terminology Criteria for Adverse Events version 4.03. Adverse events deemed "possibly", "probably", and "definitely related" to opioid use by the Investigator were summarized for the study.
Nervous system disorders Nervous system disorders - Other, Change in mental status	2.7% 2/75 • Number of events 2 • From enrollment date (i.e., buccal swab is collected) (Day 0) to the final study assessment on Day 30 +/- 7. Opioid-related adverse events were summarized and attributed based on Common Terminology Criteria for Adverse Events version 4.03. Adverse events deemed "possibly", "probably", and "definitely related" to opioid use by the Investigator were summarized for the study.
Nervous system disorders Neuralgia	1.3% 1/75 • Number of events 1 • From enrollment date (i.e., buccal swab is collected) (Day 0) to the final study assessment on Day 30 +/- 7. Opioid-related adverse events were summarized and attributed based on Common Terminology Criteria for Adverse Events version 4.03. Adverse events deemed "possibly", "probably", and "definitely related" to opioid use by the Investigator were summarized for the study.
Skin and subcutaneous tissue disorders Pruritus	2.7% 2/75 • Number of events 3 • From enrollment date (i.e., buccal swab is collected) (Day 0) to the final study assessment on Day 30 +/- 7. Opioid-related adverse events were summarized and attributed based on Common Terminology Criteria for Adverse Events version 4.03. Adverse events deemed "possibly", "probably", and "definitely related" to opioid use by the Investigator were summarized for the study.
Skin and subcutaneous tissue disorders Rash acneiform	1.3% 1/75 • Number of events 2 • From enrollment date (i.e., buccal swab is collected) (Day 0) to the final study assessment on Day 30 +/- 7. Opioid-related adverse events were summarized and attributed based on Common Terminology Criteria for Adverse Events version 4.03. Adverse events deemed "possibly", "probably", and "definitely related" to opioid use by the Investigator were summarized for the study.
Nervous system disorders Somnolence	2.7% 2/75 • Number of events 2 • From enrollment date (i.e., buccal swab is collected) (Day 0) to the final study assessment on Day 30 +/- 7. Opioid-related adverse events were summarized and attributed based on Common Terminology Criteria for Adverse Events version 4.03. Adverse events deemed "possibly", "probably", and "definitely related" to opioid use by the Investigator were summarized for the study.
Gastrointestinal disorders Vomiting	6.7% 5/75 • Number of events 5 • From enrollment date (i.e., buccal swab is collected) (Day 0) to the final study assessment on Day 30 +/- 7. Opioid-related adverse events were summarized and attributed based on Common Terminology Criteria for Adverse Events version 4.03. Adverse events deemed "possibly", "probably", and "definitely related" to opioid use by the Investigator were summarized for the study.

Additional Information

Danielle M Boselli

Atrium Health/Levine Cancer Institute, Department of Cancer Biostatistics

Phone: 12017903385

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place