Trial Outcomes & Findings for Minocycline Study in Non Small Cell Lung Cancer (NSCLC) Patients for Chemoradiation Therapy (NCT NCT01636934)

Last Updated: 2020-07-17

Results Overview

Primary outcome variable for this trial will be the mean difference between AUC values recorded for patients assigned to the treatment and control arms. AUC values calculated for the five M.D. Anderson Symptom Inventory (MDASI) items corresponding to fatigue, pain, disturbed sleep, lack of appetite, and sore throat. AUC is sum of the area of the trapezoids that can be fitted during the 12 week period and is measured in units of mean MDASI score in days. 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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

51 participants

Primary outcome timeframe

up to 12 weeks

Results posted on

2020-07-17

Participant Flow

Recruitment period: January 22, 2013 to August, 19 2015. All recruitment done at the University of Texas MD Anderson Cancer

Of the 51 participants enrolled 2 participant were excluded from the study before assignment to groups.

Participant milestones

Participant milestones
Measure	Minocycline Minocycline 100 mg twice a day during standard of care chemoradiation therapy plus additional follow up for 5 weeks, for a total of 12 weeks.	Placebo Placebo 100 mg twice a day during during standard of care chemoradiation plus additional follow up for 5 weeks, for a total of 12 weeks.
Overall Study STARTED	25	24
Overall Study COMPLETED	19	21
Overall Study NOT COMPLETED	6	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Minocycline Minocycline 100 mg twice a day during standard of care chemoradiation therapy plus additional follow up for 5 weeks, for a total of 12 weeks.	Placebo Placebo 100 mg twice a day during during standard of care chemoradiation plus additional follow up for 5 weeks, for a total of 12 weeks.
Overall Study Withdrawal by Subject	3	2
Overall Study Chemo cancel	1	0
Overall Study Too ill to continue	1	0
Overall Study Never started study medication	1	1

Baseline Characteristics

Minocycline Study in Non Small Cell Lung Cancer (NSCLC) Patients for Chemoradiation Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Minocycline n=19 Participants Minocycline 100 mg twice a day during standard of care chemoradiation therapy plus additional follow up for 5 weeks, for a total of 12 weeks.	Placebo n=21 Participants Placebo 100 mg twice a day during during standard of care chemoradiation plus additional follow up for 5 weeks, for a total of 12 weeks.	Total n=40 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
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	6 Participants n=7 Participants	19 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	15 Participants n=7 Participants	21 Participants n=5 Participants
Age, Continuous	62.4 years STANDARD_DEVIATION 8.1 • n=5 Participants	67.3 years STANDARD_DEVIATION 6.3 • n=7 Participants	64.8 years STANDARD_DEVIATION 7.2 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	20 Participants n=7 Participants	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 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
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	20 Participants n=7 Participants	38 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants	21 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 12 weeks

Population: Of the 49 randomized patients, 40 were evaluable for the primary efficacy analysis

Outcome measures

Outcome measures
Measure	Minocycline n=19 Participants Minocycline 100 mg twice a day during standard of care chemoradiation therapy plus additional follow up for 5 weeks, for a total of 12 weeks.	Placebo n=21 Participants Placebo 100 mg twice a day during during standard of care chemoradiation plus additional follow up for 5 weeks, for a total of 12 weeks.
AUC Value Symptom Severity Differences Fatigue	31.18 Units on a scale *week Standard Deviation 14.22	44.98 Units on a scale *week Standard Deviation 20.9
AUC Value Symptom Severity Differences Pain	17.13 Units on a scale *week Standard Deviation 12.4	26.64 Units on a scale *week Standard Deviation 21.56
AUC Value Symptom Severity Differences Disturbed Sleep	17.34 Units on a scale *week Standard Deviation 14.29	19.5 Units on a scale *week Standard Deviation 16.41
AUC Value Symptom Severity Differences Lack of Appetite	17.16 Units on a scale *week Standard Deviation 15.76	27.31 Units on a scale *week Standard Deviation 24.95
AUC Value Symptom Severity Differences Soar Throat	4.45 Units on a scale *week Standard Deviation 7.23	4.36 Units on a scale *week Standard Deviation 9.51

SECONDARY outcome

Timeframe: up to 12 weeks

Population: The blood sample collection was an optional procedure for the participants no data were not collected.

To examine the effectiveness of minocycline in reducing treatment-induced inflammatory response (serum C-reactive protein (CRP), interleukin (IL)-6, TNF-a, sTNF-R1, sTNF-R2, and activation of indoleamine 2,3-dioxygenase (IDO)).

Outcome measures

Outcome data not reported

Adverse Events

Minocycline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Zhongxing Liao, MD/ Professor, Radiation Oncology Department

UT 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