Trial Outcomes & Findings for Minocycline for Reduction of Radiation Therapy Treatment-Related Symptom Burden in Oropharynx Cancer: A Randomized Study. (NCT NCT01173692)

Last Updated: 2021-08-20

Results Overview

7-week (+/- 5 days) average area under the curve (AUC) for select MD Anderson Symptom Inventory for head and neck cancer (MDASI-HNC) symptoms namely fatigue, pain, sleep disturbance, difficulty swallowing and lack of appetite reported in the symptom survey. Each item is rated on a 11-point scale from 0 (not at all) to 10 (as bad as you can imagine). Higher values represent a worse outcome.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

47 participants

Primary outcome timeframe

Up to 7 weeks

Results posted on

2021-08-20

Participant Flow

Recruitment period: July 22, 2010 to Oct 10, 2013. All recruitment done at the University of Texas MD Anderson Cancer

47 participants enrolled and assigned to the study drug. 7 participants withdraw after consent or within 2 weeks.

Participant milestones

Participant milestones
Measure	Minocycline Minocycline 100mg (capsule) two times a day during the entire course of radiation therapy (7 weeks ± 5 days)	Placebo Placebo 100mg (capsule) two times a day during the entire course of radiation therapy (7 weeks ± 5 days)
Overall Study STARTED	22	25
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Minocycline Minocycline 100mg (capsule) two times a day during the entire course of radiation therapy (7 weeks ± 5 days)	Placebo Placebo 100mg (capsule) two times a day during the entire course of radiation therapy (7 weeks ± 5 days)
Overall Study Adverse Event	1	2
Overall Study Withdrawal by Subject	1	3

Baseline Characteristics

Minocycline for Reduction of Radiation Therapy Treatment-Related Symptom Burden in Oropharynx Cancer: A Randomized Study.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Minocycline n=20 Participants Minocycline 100mg (capsule) two times a day during the entire course of radiation therapy (7 weeks ± 5 days)	Placebo n=20 Participants Placebo 100mg (capsule) two times a day during the entire course of radiation therapy (7 weeks ± 5 days)	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	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	17 Participants n=7 Participants	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants	20 Participants n=7 Participants	39 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	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	20 Participants n=7 Participants	39 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	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 7 weeks

Population: Of 47 randomized patients, 40 (85% were evaluable for the primary efficacy analysis)

Outcome measures

Outcome measures
Measure	Minocycline n=20 Participants Minocycline 100mg (capsule) two times a day during the entire course of radiation therapy (7 weeks ± 5 days)	Placebo n=20 Participants Placebo 100mg (capsule) two times a day during the entire course of radiation therapy (7 weeks ± 5 days)
Combined AUC for Selected Patient Symptoms	3.1 score on a scale*week Standard Deviation 1	3.7 score on a scale*week Standard Deviation 1.7

Adverse Events

Minocycline

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

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	Minocycline n=20 participants at risk Minocycline 100mg (capsule) two times a day during the entire course of radiation therapy (7 weeks ± 5 days)	Placebo n=20 participants at risk Placebo 100mg (capsule) two times a day during the entire course of radiation therapy (7 weeks ± 5 days)
Gastrointestinal disorders Nausea	5.0% 1/20 • Number of events 1 • From the start of the study medication, up to 30 days after last dose administered.	10.0% 2/20 • Number of events 2 • From the start of the study medication, up to 30 days after last dose administered.
Gastrointestinal disorders Vomiting	5.0% 1/20 • Number of events 1 • From the start of the study medication, up to 30 days after last dose administered.	0.00% 0/20 • From the start of the study medication, up to 30 days after last dose administered.
Gastrointestinal disorders Diarrhea	5.0% 1/20 • Number of events 1 • From the start of the study medication, up to 30 days after last dose administered.	0.00% 0/20 • From the start of the study medication, up to 30 days after last dose administered.
Nervous system disorders Dizziness	5.0% 1/20 • Number of events 1 • From the start of the study medication, up to 30 days after last dose administered.	0.00% 0/20 • From the start of the study medication, up to 30 days after last dose administered.

Additional Information

Brandon Gunn, MD/ Associate Professor, Radiation Oncology Department

UT MD Anderson Cancer Center

Phone: (713) 563-2562

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place