Trial Outcomes & Findings for A Study for Reducing Symptom Burden Produced by Chemoradiation Treatment for Non Small Cell Lung Cancer by Minocycline and Armodafinil (NCT NCT01317550)

Last Updated: 2020-02-10

Results Overview

Each item is rated on a 0 to 10 scale with 0 = symptom not present or no interference and 10 meaning the symptom severity is as bad as can be imagine or complete interference using the MD Anderson Symptom Inventory (MDASI). It is a measure of symptom burden, which includes symptom severity and how they interfere with daily functioning. For this study, the sub scale is the average of the 5 pre-selected items namely fatigue, pain, disturbed sleep, lack of appetite and drowsiness. This subscale ranges from 0 to 10. The primary outcome is the average of the 70-day area (10 week study) under the curve for the sub scale. AUC ranges from 0 (0\*70) to 700 (10\*70). To put this into perspective, the average AUC for the placebo group of 200.8 can also be thought of as 2.87 (200.8/70) on a 0 to 10 scale over the 70 day study period. Lower values represent better outcome. Higher values represent worse outcome.

Recruitment status

COMPLETED

Study phase

Target enrollment

14 participants

Primary outcome timeframe

During 10 weeks of CXRT

Results posted on

2020-02-10

Participant Flow

Recruitment Period: July 15, 2011 to October 21, 2013. All recruitment done at The University of Texas MD Anderson Cancer Center.

Participant milestones

Participant milestones
Measure	Armodafinil Armodafinil 150mg (capsule) once a day during entire course of radiation therapy for 10 weeks	Minocycline Minocycline 100mg (capsule) two times a day during the entire course of radiation therapy for 10 weeks	Armodafinil + Minocycline Armodafinil orally 150 mg/day for 10 weeks + Minocycline orally 100 mg twice/day for 10 weeks	Matching Placebo Placebo capsules orally once/day for 10 weeks
Overall Study STARTED	5	3	3	3
Overall Study COMPLETED	3	3	3	3
Overall Study NOT COMPLETED	2	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Armodafinil Armodafinil 150mg (capsule) once a day during entire course of radiation therapy for 10 weeks	Minocycline Minocycline 100mg (capsule) two times a day during the entire course of radiation therapy for 10 weeks	Armodafinil + Minocycline Armodafinil orally 150 mg/day for 10 weeks + Minocycline orally 100 mg twice/day for 10 weeks	Matching Placebo Placebo capsules orally once/day for 10 weeks
Overall Study Withdrawal by Subject	1	0	0	0
Overall Study Lack of compliance study med	1	0	0	0

Baseline Characteristics

A Study for Reducing Symptom Burden Produced by Chemoradiation Treatment for Non Small Cell Lung Cancer by Minocycline and Armodafinil

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Armodafinil n=3 Participants Armodafinil 150mg (capsule) once a day during entire course of radiation therapy for 10 weeks	Minocycline n=3 Participants Minocycline 100mg (capsule) two times a day during the entire course of radiation therapy for 10 weeks	Armodafinil+Minocycline n=3 Participants Armodafinil orally 150 mg/day for 10 weeks + Minocycline orally 100 mg twice/day for 10 weeks	Matching Placebo n=3 Participants Placebo capsules orally once/day for 10 weeks	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	7 Participants n=21 Participants
Age, Continuous	63.67 Years STANDARD_DEVIATION 7.09 • n=5 Participants	60 Years STANDARD_DEVIATION 11.36 • n=7 Participants	66.33 Years STANDARD_DEVIATION 8.08 • n=5 Participants	65 Years STANDARD_DEVIATION 12.77 • n=4 Participants	63.75 Years STANDARD_DEVIATION 8.96 • n=21 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	6 Participants n=21 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	12 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	11 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	3 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants	3 participants n=4 Participants	12 participants n=21 Participants

PRIMARY outcome

Timeframe: During 10 weeks of CXRT

Population: Of the 14 randomized patients, 12 (85% were evaluable for the primary efficacy analysis).

Outcome measures

Outcome measures
Measure	Armodafinil n=3 Participants Armodafinil 150mg (capsule) once a day during entire course of radiation therapy (10 weeks + 2 days	Minocycline n=3 Participants Minocycline 100mg (capsule) two times a day during the entire course of radiation therapy (10 weeks + 2 days)	Armodafinil+Minocycline n=3 Participants Armodafinil orally 150 mg/day for 10 weeks + Minocycline orally 100 mg twice/day for 10 weeks	Matching Placebo n=3 Participants Placebo Capsules orally once/day for 10 weeks
Primary Outcome Variable: Combined AUC of Selected Symptoms Fatigue, Pain, Disturbed Sleep, Lack of Appetite and Drowsiness Fatigue	259.3 Units on a scale week Standard Deviation 168.5	127.2 Units on a scale week Standard Deviation 60.5	372 Units on a scale week Standard Deviation 113.5	279.8 Units on a scale week Standard Deviation 193.6
Primary Outcome Variable: Combined AUC of Selected Symptoms Fatigue, Pain, Disturbed Sleep, Lack of Appetite and Drowsiness Lack of appetite	133.3 Units on a scale week Standard Deviation 134.6	27.7 Units on a scale week Standard Deviation 28.1	298.3 Units on a scale week Standard Deviation 23.3	189 Units on a scale week Standard Deviation 72.6
Primary Outcome Variable: Combined AUC of Selected Symptoms Fatigue, Pain, Disturbed Sleep, Lack of Appetite and Drowsiness Average AUC	157.4 Units on a scale week Standard Deviation 181.4	81.1 Units on a scale week Standard Deviation 22.2	255.9 Units on a scale week Standard Deviation 65.3	200.8 Units on a scale week Standard Deviation 106.9
Primary Outcome Variable: Combined AUC of Selected Symptoms Fatigue, Pain, Disturbed Sleep, Lack of Appetite and Drowsiness Pain	145.8 Units on a scale week Standard Deviation 233.6	114.5 Units on a scale week Standard Deviation 135.6	185.3 Units on a scale week Standard Deviation 121.	190 Units on a scale week Standard Deviation 96.7
Primary Outcome Variable: Combined AUC of Selected Symptoms Fatigue, Pain, Disturbed Sleep, Lack of Appetite and Drowsiness Disturbed Sleep	109.2 Units on a scale week Standard Deviation 165	80 Units on a scale week Standard Deviation 44.3	213.2 Units on a scale week Standard Deviation 81.5	224.7 Units on a scale week Standard Deviation 205.7
Primary Outcome Variable: Combined AUC of Selected Symptoms Fatigue, Pain, Disturbed Sleep, Lack of Appetite and Drowsiness Drowsiness	139.3 Units on a scale week Standard Deviation 209.7	59.2 Units on a scale week Standard Deviation 32.8	210.7 Units on a scale week Standard Deviation 82.3	120.3 Units on a scale week Standard Deviation 69.5

Adverse Events

Armodafinil + Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Minocycline + Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Armodafinil + Minocycline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebos

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Zhongxing Liao, MD/Professor, Radiation Oncology Department

MD Anderson Cancer Center

Phone: 713-563-2300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place