Trial Outcomes & Findings for Minocycline for Postsurgical Symptom Reduction in Head and Neck Cancer (NCT NCT02055963)
NCT ID: NCT02055963
Last Updated: 2022-10-20
Results Overview
Primary outcome variable is area under the curve (AUC) using the average of the 3 most severe symptoms (pain, fatigue, and disturbed sleep) beginning 2 days prior to surgery and ending 21 days postsurgery. AUC calculated using trapezoidal approximation. The base of a trapezoid corresponds to the number of days between assessments while the heights correspond to 2 adjoining symptom responses. The number of trapezoids depends on the number of symptom assessments. The sum of the area for all the trapezoids represents the AUC of a particular patient. Data were collected to create the curve (-2, 0, 1, 3, 5, 7, 10, 14, 17, and 21 days post-dose)
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
-2 to 21 days post-dose
Results posted on
2022-10-20
Participant Flow
All participants enrolled at MD Anderson Cancer Center.
Participant milestones
| Measure |
Minocycline
Participants take study medication twice daily, starting 2 days prior to surgery, and continue for 3 weeks postsurgery. The final day of study medication will be the 21st day after surgery.
Minocycline100 mg given orally every 12 hours on Day -2, (i.e., 2 days prior to surgery) and continuing for 3 weeks postsurgery.
Questionnaire completion 2 days before surgery, on day of surgery, 1 and 3 days after surgery, then twice a week until follow up visit on day 21.
|
Placebo
Participants take study medication twice daily, starting 2 days prior to surgery, and continue for 3 weeks postsurgery. The final day of study medication will be the 21st day after surgery.
Placebo 100 mg given orally every 12 hours on Day -2, (i.e., 2 days prior to surgery).
Questionnaire completion 2 days before surgery, on day of surgery, 1 and 3 days after surgery, then twice a week until follow up visit on day 21.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
16
|
|
Overall Study
COMPLETED
|
14
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Minocycline for Postsurgical Symptom Reduction in Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Minocycline
n=14 Participants
Participants take study medication twice daily, starting 2 days prior to surgery, and continue for 3 weeks postsurgery. The final day of study medication will be the 21st day after surgery.
Minocycline100 mg given orally every 12 hours on Day -2, (i.e., 2 days prior to surgery) and continuing for 3 weeks postsurgery.
Questionnaire completion 2 days before surgery, on day of surgery, 1 and 3 days after surgery, then twice a week until follow up visit on day 21.
|
Placebo
n=16 Participants
Participants take study medication twice daily, starting 2 days prior to surgery, and continue for 3 weeks postsurgery. The final day of study medication will be the 21st day after surgery.
Placebo 100 mg given orally every 12 hours on Day -2, (i.e., 2 days prior to surgery).
Questionnaire completion 2 days before surgery, on day of surgery, 1 and 3 days after surgery, then twice a week until follow up visit on day 21.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
20 to 29 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Customized
30 to 39 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Customized
40 to 49 years
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Customized
50 to 59 years
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Age, Customized
60 to 69 years
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Age, Customized
70 to 79 years
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Age, Customized
80 to 89 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black Non-Hispanic
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
9 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=99 Participants
|
16 participants
n=107 Participants
|
30 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: -2 to 21 days post-dosePopulation: 4 participants were not included in the primary efficacy analysis due to 3 dropped out before 1 week (1 in the Minocycline Arm and 2 in the Placebo Arm) and 1 participants in the Minocycline Arm the MD Anderson Symptom Inventory (MDASI) was not evaluated.
Primary outcome variable is area under the curve (AUC) using the average of the 3 most severe symptoms (pain, fatigue, and disturbed sleep) beginning 2 days prior to surgery and ending 21 days postsurgery. AUC calculated using trapezoidal approximation. The base of a trapezoid corresponds to the number of days between assessments while the heights correspond to 2 adjoining symptom responses. The number of trapezoids depends on the number of symptom assessments. The sum of the area for all the trapezoids represents the AUC of a particular patient. Data were collected to create the curve (-2, 0, 1, 3, 5, 7, 10, 14, 17, and 21 days post-dose)
Outcome measures
| Measure |
Minocycline
n=12 Participants
Participants take study medication twice daily, starting 2 days prior to surgery, and continue for 3 weeks postsurgery. The final day of study medication will be the 21st day after surgery.
Minocycline100 mg given orally every 12 hours on Day -2, (i.e., 2 days prior to surgery) and continuing for 3 weeks postsurgery.
Questionnaire completion 2 days before surgery, on day of surgery, 1 and 3 days after surgery, then twice a week until follow up visit on day 21.
|
Placebo
n=14 Participants
Participants take study medication twice daily, starting 2 days prior to surgery, and continue for 3 weeks postsurgery. The final day of study medication will be the 21st day after surgery.
Placebo 100 mg given orally every 12 hours on Day -2, (i.e., 2 days prior to surgery).
Questionnaire completion 2 days before surgery, on day of surgery, 1 and 3 days after surgery, then twice a week until follow up visit on day 21.
|
|---|---|---|
|
Efficacy of Minocycline for Reducing Patient-Reported Symptoms
|
66.4 mcg*hr/mL
Standard Deviation 32.4
|
67.5 mcg*hr/mL
Standard Deviation 38.2
|
SECONDARY outcome
Timeframe: Day -2, Day 0, Day 1, Day 3, Day 5, Day 7, Day 10, Day 14, Day 17, Day 20Time-to-symptom-recovery defined to be the time it takes for symptom severity (average of pain, fatigue and disturbed sleep) to return to preoperative levels for 2 consecutive assessments. Repeated measures ANOVA performed with group (minocycline vs. placebo), time (presurgery, postsurgery, discharge, follow up) and group-by-time interaction as factors and proinflammatory cytokine level as a dependent variable. Data measured at Day -2, Day 0, Day 1, Day 3, Day 5, Day 7, Day 10, Day 14, Day 17, Day 20. Cox proportional hazards models were used to explore predictors of time-to-symptom-recovery.
Outcome measures
| Measure |
Minocycline
n=14 Participants
Participants take study medication twice daily, starting 2 days prior to surgery, and continue for 3 weeks postsurgery. The final day of study medication will be the 21st day after surgery.
Minocycline100 mg given orally every 12 hours on Day -2, (i.e., 2 days prior to surgery) and continuing for 3 weeks postsurgery.
Questionnaire completion 2 days before surgery, on day of surgery, 1 and 3 days after surgery, then twice a week until follow up visit on day 21.
|
Placebo
n=16 Participants
Participants take study medication twice daily, starting 2 days prior to surgery, and continue for 3 weeks postsurgery. The final day of study medication will be the 21st day after surgery.
Placebo 100 mg given orally every 12 hours on Day -2, (i.e., 2 days prior to surgery).
Questionnaire completion 2 days before surgery, on day of surgery, 1 and 3 days after surgery, then twice a week until follow up visit on day 21.
|
|---|---|---|
|
Number of Participants Time-to-Symptom-Recovery
Day -2
|
12 Participants
|
14 Participants
|
|
Number of Participants Time-to-Symptom-Recovery
Day 0
|
6 Participants
|
13 Participants
|
|
Number of Participants Time-to-Symptom-Recovery
Day 1
|
11 Participants
|
14 Participants
|
|
Number of Participants Time-to-Symptom-Recovery
Day 3
|
10 Participants
|
13 Participants
|
|
Number of Participants Time-to-Symptom-Recovery
Day 5
|
9 Participants
|
14 Participants
|
|
Number of Participants Time-to-Symptom-Recovery
Day 7
|
10 Participants
|
12 Participants
|
|
Number of Participants Time-to-Symptom-Recovery
Day 10
|
11 Participants
|
12 Participants
|
|
Number of Participants Time-to-Symptom-Recovery
Day 14
|
12 Participants
|
14 Participants
|
|
Number of Participants Time-to-Symptom-Recovery
Day 17
|
11 Participants
|
13 Participants
|
|
Number of Participants Time-to-Symptom-Recovery
Day 20
|
12 Participants
|
14 Participants
|
Adverse Events
Minocycline
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Minocycline
n=14 participants at risk
Participants take study medication twice daily, starting 2 days prior to surgery, and continue for 3 weeks postsurgery. The final day of study medication will be the 21st day after surgery.
Minocycline100 mg given orally every 12 hours on Day -2, (i.e., 2 days prior to surgery) and continuing for 3 weeks postsurgery.
Questionnaire completion 2 days before surgery, on day of surgery, 1 and 3 days after surgery, then twice a week until follow up visit on day 21.
|
Placebo
n=16 participants at risk
Participants take study medication twice daily, starting 2 days prior to surgery, and continue for 3 weeks postsurgery. The final day of study medication will be the 21st day after surgery.
Placebo 100 mg given orally every 12 hours on Day -2, (i.e., 2 days prior to surgery).
Questionnaire completion 2 days before surgery, on day of surgery, 1 and 3 days after surgery, then twice a week until follow up visit on day 21.
|
|---|---|---|
|
Nervous system disorders
Stroke
|
0.00%
0/14 • From the first dose through 30 days after the last dose of study drug medication, up to week 6 ± 1 week post-surgery (in clinic or by phone)
|
6.2%
1/16 • From the first dose through 30 days after the last dose of study drug medication, up to week 6 ± 1 week post-surgery (in clinic or by phone)
|
Other adverse events
| Measure |
Minocycline
n=14 participants at risk
Participants take study medication twice daily, starting 2 days prior to surgery, and continue for 3 weeks postsurgery. The final day of study medication will be the 21st day after surgery.
Minocycline100 mg given orally every 12 hours on Day -2, (i.e., 2 days prior to surgery) and continuing for 3 weeks postsurgery.
Questionnaire completion 2 days before surgery, on day of surgery, 1 and 3 days after surgery, then twice a week until follow up visit on day 21.
|
Placebo
n=16 participants at risk
Participants take study medication twice daily, starting 2 days prior to surgery, and continue for 3 weeks postsurgery. The final day of study medication will be the 21st day after surgery.
Placebo 100 mg given orally every 12 hours on Day -2, (i.e., 2 days prior to surgery).
Questionnaire completion 2 days before surgery, on day of surgery, 1 and 3 days after surgery, then twice a week until follow up visit on day 21.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
1/14 • From the first dose through 30 days after the last dose of study drug medication, up to week 6 ± 1 week post-surgery (in clinic or by phone)
|
0.00%
0/16 • From the first dose through 30 days after the last dose of study drug medication, up to week 6 ± 1 week post-surgery (in clinic or by phone)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
7.1%
1/14 • From the first dose through 30 days after the last dose of study drug medication, up to week 6 ± 1 week post-surgery (in clinic or by phone)
|
0.00%
0/16 • From the first dose through 30 days after the last dose of study drug medication, up to week 6 ± 1 week post-surgery (in clinic or by phone)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/14 • From the first dose through 30 days after the last dose of study drug medication, up to week 6 ± 1 week post-surgery (in clinic or by phone)
|
6.2%
1/16 • From the first dose through 30 days after the last dose of study drug medication, up to week 6 ± 1 week post-surgery (in clinic or by phone)
|
|
Skin and subcutaneous tissue disorders
Hives
|
7.1%
1/14 • From the first dose through 30 days after the last dose of study drug medication, up to week 6 ± 1 week post-surgery (in clinic or by phone)
|
0.00%
0/16 • From the first dose through 30 days after the last dose of study drug medication, up to week 6 ± 1 week post-surgery (in clinic or by phone)
|
|
Skin and subcutaneous tissue disorders
Itchy
|
7.1%
1/14 • From the first dose through 30 days after the last dose of study drug medication, up to week 6 ± 1 week post-surgery (in clinic or by phone)
|
0.00%
0/16 • From the first dose through 30 days after the last dose of study drug medication, up to week 6 ± 1 week post-surgery (in clinic or by phone)
|
|
Gastrointestinal disorders
Lack of appetite
|
7.1%
1/14 • From the first dose through 30 days after the last dose of study drug medication, up to week 6 ± 1 week post-surgery (in clinic or by phone)
|
0.00%
0/16 • From the first dose through 30 days after the last dose of study drug medication, up to week 6 ± 1 week post-surgery (in clinic or by phone)
|
Additional Information
Dr. Juan P. Cata, MD-Associate Professor, Anesthesiology & PeriOper Med
UT MD Anderson Cancer Center
Phone: (713) 792-7452
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place