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Tetracycline Antibiotic
Minocycline for Head and Neck Cancers
Phase 2
Waitlist Available
Led By Juan P. Cata, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have normal hepatic function test and no prior liver disease: (1) The screening results for alanine aminotransferase (ALT) must be < 2 times the upper limit of normal. (2) The screening results for aspartate aminotransferase (AST), if available, must be < 2 times the upper limit of normal.
Patients with head and neck cancer who are undergoing either flap or nonflap surgery (limited to parotidectomy, hard palate maxillectomy and glossectomy, mandibulectomy, and any procedure with neck dissection) at MD Anderson Cancer Center.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day -2, day 0, day 1, day 3, day 5, day 7, day 10, day 14, day 17, day 20
Awards & highlights
Study Summary
This trial is designed to see if Minocin can help reduce symptoms like pain, fatigue, and poor sleep in patients who have had surgery for head and neck cancer.
Eligible Conditions
- Head and Neck Cancers
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day -2, day 0, day 1, day 3, day 5, day 7, day 10, day 14, day 17, day 20
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day -2, day 0, day 1, day 3, day 5, day 7, day 10, day 14, day 17, day 20
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy of Minocycline for Reducing Patient-Reported Symptoms
Secondary outcome measures
Number of Participants Time-to-Symptom-Recovery
Side effects data
From 2016 Phase 4 trial • 10 Patients • NCT0212481140%
Inpatient psychiatric hospitalization
20%
Hospitalization due to ischemic colitis
20%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Low CRP
High CRP
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MinocyclineExperimental Treatment2 Interventions
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.
Group II: PlaceboPlacebo Group2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Minocycline
2005
Completed Phase 4
~1000
Questionnaires
2013
Completed Phase 2
~3030
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,419 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,616 Total Patients Enrolled
Juan P. Cata, MDPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
95 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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