Minocycline for Postsurgical Symptom Reduction in Head and Neck Cancer
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ClinicalTrials.gov Identifier: NCT02055963 |
Recruitment Status :
Active, not recruiting
First Posted : February 5, 2014
Last Update Posted : July 2, 2020
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The goal of this clinical research study is to learn if Minocin® (minocycline) can reduce certain side effects of surgery in patients with head and neck cancer (such as pain, fatigue, and disturbed sleep). In this study, minocycline will be compared to a placebo.
A placebo is not a drug. It looks like the study drug, but it is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Head And Neck Cancer | Drug: Minocycline Drug: Placebo Behavioral: Questionnaires | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Minocycline for Reduction of Symptom Burden After Surgery in Patients With Head and Neck Malignancy: A Randomized Study |
Actual Study Start Date : | May 2014 |
Estimated Primary Completion Date : | December 31, 2020 |
Estimated Study Completion Date : | December 31, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: 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. |
Drug: Minocycline
100 mg given orally every 12 hours on Day -2, (i.e., 2 days prior to surgery) and continuing for 3 weeks postsurgery.
Other Names:
Behavioral: Questionnaires 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.
Other Name: Surveys |
Placebo Comparator: 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. |
Drug: Placebo
Placebo 100 mg given orally every 12 hours on Day -2, (i.e., 2 days prior to surgery) and continuing for 3 weeks postsurgery.
Other Name: Sugar pill Behavioral: Questionnaires 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.
Other Name: Surveys |
- Efficacy of Minocycline for Reducing Patient-Reported Symptoms [ Time Frame: 21 days ]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.
- Time-to-Symptom-Recovery [ Time Frame: 2 weeks after surgery ]Time-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. Rate of change calculated in symptom severity for 2 weeks postsurgery and its relationship determined with proinflammatory cytokine levels and damage-associated molecular patterns (DAMPS) immediately after surgery. Paired t-test used to determine whether there is a significant increase in DAMPS before and after surgery.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
- Patients > 18 years old.
- Patients who have not undergone surgery in the past 6 months. Patients may have had neoadjuvant chemotherapy prior to surgery.
- Patients must have normal renal function test and no prior renal disease. The screening cut off for serum creatinine is < 1.5mg/dL.
- 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 who speak English or Spanish (due to the novel research and its complexity, we are only accruing English-speaking or Spanish-speaking patients to the protocol).
- Patients must be willing and able to review, understand, and provide written consent.
- Patients must be willing to discontinue taking dong quai and/or St. John's wort.
Exclusion Criteria:
- Patients who are taking medications (including minocycline) or have conditions that potentially preclude use of the study medication or intervention as determined by the treating physician.
- Patients who are enrolled in another symptom management trial or receiving active treatment under another clinical trial.
- Patients with a history of clinically significant cutaneous drug reaction, hypersensitivity reaction, anaphylaxis or any other serious adverse reaction to any of the anesthetics or analgesics medications used in the study.
- Patients with hypersensitivity to any tetracycline.
- Patients on vitamin K antagonist (i.e., warfarin).
- Patients taking any tetracycline within the last 15 days.
- Patients who have been on opioid therapy for the last 4 weeks or more.
- Patients with bile duct obstruction.
- Patients who are pregnant.
- Patients with INR > 1.5.
- Patients with autoimmune disease.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02055963
United States, Texas | |
University of Texas MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Juan P. Cata, MD | M.D. Anderson Cancer Center |
Responsible Party: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT02055963 |
Other Study ID Numbers: |
2013-0510 R01CA026582 ( U.S. NIH Grant/Contract ) NCI-2014-01979 ( Registry Identifier: NCI CTRP ) |
First Posted: | February 5, 2014 Key Record Dates |
Last Update Posted: | July 2, 2020 |
Last Verified: | July 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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