Trial Outcomes & Findings for Doxepin Hydrochloride in Treating Esophageal Pain in Patients With Thoracic Cancer Receiving Radiation Therapy to the Thorax With or Without Chemotherapy (NCT NCT02062632)

Results Overview

Average Area Under the Curve per assessment (aAUCpa) of pain for the first cycle of treatment. Scores are reported on a 0-100 scale, where 100=better outcome QOL. The aAUCpa is the average of each AUC between each sequential assessment. Patients will assess their pain at baseline and at 5, 15, 30, 60, 120, and 240 minutes after treatment. The AUC calculation is based on the assessment number (1,2,3,4,5,6) instead of the actual number of minutes (5,15,30,60,120,240). This results in an AUC measure that is the average pain score across all of the measurements and is not a function of the number of minutes from treatment. The area under the curve of these 6 time points will be adjusted by their baseline pain score. The pain scores at each time point are given equal weights in the AUC calculation and the AUC calculation does not use the number of minutes after treatment. Therefore, the AUC measurement scale is the same as the original pain score scale.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

Baseline and 5, 15, 30, 60, 120, and 240 minutes after treatment on day 1

Results posted on

2019-10-01

Participant Flow

5 were accrued but only 3 provided data. Since only 1 patient was accrued \& completed the study on 1 arm, patient confidentiality prevents the reporting of results per intervention. 2nd crossover was optional; none chose to crossover. The study results are only reported for the 1st study period (before crossover) \& only for placebo intervention.

Participant milestones

Participant milestones
Measure	Placebo Patients receive placebo oral solution (swish, gargle for 30 seconds, and slowly swallow) on day 1.
Overall Study STARTED	3
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Patients receive placebo oral solution (swish, gargle for 30 seconds, and slowly swallow) on day 1.
Overall Study No treatment data	1

Baseline Characteristics

Doxepin Hydrochloride in Treating Esophageal Pain in Patients With Thoracic Cancer Receiving Radiation Therapy to the Thorax With or Without Chemotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=3 Participants Patients receive placebo oral solution (swish, gargle for 30 seconds, and slowly swallow) on day 1.
Age, Continuous	61.3 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 5, 15, 30, 60, 120, and 240 minutes after treatment on day 1

Population: 5 were accrued but only 3 provided data. Since only 1 patient was accrued \& completed the study on 1 arm, patient confidentiality prevents the reporting of results per intervention. 2nd crossover was optional; none chose to crossover. The study results are only reported for the 1st study period (before crossover) \& only for placebo intervention.

Average Area Under the Curve per assessment (aAUCpa) of pain for the first cycle of treatment. Scores are reported on a 0-100 scale, where 100=better outcome QOL. The aAUCpa is the average of each AUC between each sequential assessment. Patients will assess their pain at baseline and at 5, 15, 30, 60, 120, and 240 minutes after treatment. The AUC calculation is based on the assessment number (1,2,3,4,5,6) instead of the actual number of minutes (5,15,30,60,120,240). This results in an AUC measure that is the average pain score across all of the measurements and is not a function of the number of minutes from treatment. The area under the curve of these 6 time points will be adjusted by their baseline pain score. The pain scores at each time point are given equal weights in the AUC calculation and the AUC calculation does not use the number of minutes after treatment. Therefore, the AUC measurement scale is the same as the original pain score scale.

Outcome measures

Outcome measures
Measure	Placebo n=3 Participants Patients receive placebo oral solution (swish, gargle for 30 seconds, and slowly swallow) on day 1.
Change in Mouth Pain as Measured by Average Area Under the Curve Per Assessment Patient #1	-1.6 units on a scale
Change in Mouth Pain as Measured by Average Area Under the Curve Per Assessment Patient #2	0 units on a scale
Change in Mouth Pain as Measured by Average Area Under the Curve Per Assessment Patient #3	NA units on a scale Patient did not report a baseline pain score, so an AUC adjusted for baseline could not be calculated.

SECONDARY outcome

Timeframe: Up to 4 hours after treatment

Population: 5 were accrued but only 3 provided data. Since only 1 patient was accrued \& completed the study on 1 arm, patient confidentiality prevents the reporting of results per intervention. 2nd crossover was optional; none chose to crossover. The study results are only reported for the 1st study period (before crossover) \& only for placebo intervention.

Incidence of any grade 3 or higher adverse events using Common Terminology Criteria for Adverse Events (CTCAE). Number or patients reporting a grade 3 or higher adverse event according to CTCAE

Outcome measures

Outcome measures
Measure	Placebo n=3 Participants Patients receive placebo oral solution (swish, gargle for 30 seconds, and slowly swallow) on day 1.
Incidence of Any Grade 3 or Higher Adverse Events Using Common Terminology Criteria for Adverse Events (CTCAE)	0 Participants

SECONDARY outcome

Timeframe: Up to 4 hours after treatment

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=3 participants at risk Patients receive placebo oral solution (swish, gargle for 30 seconds, and slowly swallow) on day 1.
Ear and labyrinth disorders Tinnitus	33.3% 1/3 • Number of events 1 • Up to 4 hours after treatment on day 3 Since only one patient was accrued and completed the study on one arm, patient confidentiality prevents the reporting of results per intervention. Therefore, the study results are only reported for the first study period (before crossover) and only for a single intervention (placebo).Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Gastrointestinal disorders Constipation	33.3% 1/3 • Number of events 1 • Up to 4 hours after treatment on day 3 Since only one patient was accrued and completed the study on one arm, patient confidentiality prevents the reporting of results per intervention. Therefore, the study results are only reported for the first study period (before crossover) and only for a single intervention (placebo).Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Gastrointestinal disorders Esophagitis	33.3% 1/3 • Number of events 1 • Up to 4 hours after treatment on day 3 Since only one patient was accrued and completed the study on one arm, patient confidentiality prevents the reporting of results per intervention. Therefore, the study results are only reported for the first study period (before crossover) and only for a single intervention (placebo).Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Gastrointestinal disorders Nausea	66.7% 2/3 • Number of events 2 • Up to 4 hours after treatment on day 3 Since only one patient was accrued and completed the study on one arm, patient confidentiality prevents the reporting of results per intervention. Therefore, the study results are only reported for the first study period (before crossover) and only for a single intervention (placebo).Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
General disorders Fatigue	66.7% 2/3 • Number of events 2 • Up to 4 hours after treatment on day 3 Since only one patient was accrued and completed the study on one arm, patient confidentiality prevents the reporting of results per intervention. Therefore, the study results are only reported for the first study period (before crossover) and only for a single intervention (placebo).Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Nervous system disorders Dizziness	33.3% 1/3 • Number of events 1 • Up to 4 hours after treatment on day 3 Since only one patient was accrued and completed the study on one arm, patient confidentiality prevents the reporting of results per intervention. Therefore, the study results are only reported for the first study period (before crossover) and only for a single intervention (placebo).Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Nervous system disorders Somnolence	33.3% 1/3 • Number of events 1 • Up to 4 hours after treatment on day 3 Since only one patient was accrued and completed the study on one arm, patient confidentiality prevents the reporting of results per intervention. Therefore, the study results are only reported for the first study period (before crossover) and only for a single intervention (placebo).Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.

Additional Information

Terence T. Sio, MD, MS

Mayo Clinic

Phone: 507/284-2511

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place