Clinical trial · Interventional
Minocycline for Postsurgical Symptom Reduction in Head and Neck Cancer
Minocycline for Reduction of Symptom Burden After Surgery in Patients With Head and Neck Malignancy: A Randomized Study
NCT02055963CI-TRIAL-00061586terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Early termination due to the protocol lack of progress in improving accrual rate
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head And Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Minocycline | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Minocycline
- description
- 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.
- interventionNames
- Drug: Minocycline
- Behavioral: Questionnaires
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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. 2. Patients \> 18 years old. 3. Patients who have not undergone surgery in the past 6 months. Patients may have had neoadjuvant chemotherapy prior to surgery. 4. Patients must have normal renal function test and no prior renal disease. The screening cut off for serum creatinine is \< 1.5mg/dL. 5. 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. 6. 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). 7. Patients must be willing and able to review, understand, and provide written consent. 8. Patients must be willing to discontinue taking dong quai and/or St. John's wort. Exclusion Criteria: 1. 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. 2. Patients who are enrolled in another symptom management trial or receiving active treatment under another clinical trial. 3. 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. 4. Patients with hypersensitivity to any tetracycline. 5. Patients on vitamin K antagonist (i.e., warfarin). 6. Patients taking any tetracycline within the last 15 days. 7. Patients who have been on opioid therapy for the last 4 weeks or more. 8. Patients with bile duct obstruction. 9. Patients who are pregnant. 10. Patients with INR \> 1.5. 11. Patients with autoimmune disease.
References
Publications (0)
Data not yet available
No reference posted for this study.