Clinical trial · Interventional
Minocycline for Reduction of Radiation Therapy Treatment-Related Symptom Burden in Oropharynx Cancer: A Randomized Study.
NCT01173692CI-TRIAL-00053427completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical research study is to learn if minocycline can reduce the symptoms reported by patients with oropharynx cancer, nasopharynx cancer, or unknown primary cancer of head and neck, who receive treatment with radiation therapy.
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 |
|---|---|---|---|
| Oropharynx Cancer | Malignant Oropharyngeal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Minocycline | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Twice Daily Orally
- interventionNames
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- Minocycline
- description
- 100 mg Twice Daily Orally
- interventionNames
- Drug: Minocycline
Primary outcomes (1)
- measure
- Combined AUC for Selected Patient Symptoms
- timeFrame
- Up to 7 weeks
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with a pathologically proven diagnosis of oropharyngeal cancer, nasopharyngeal cancer, or unknown primary cancer of head and neck in MDACC receiving radiation therapy with or without induction chemotherapy. 2. Patients \> = 18 years old. 3. Patients with the above cancers, T0, TX, T1 to T3, N any, M0 receiving IMRT (to unilateral or bilateral neck) at least 64-72 Gy in 6-7 weeks as definitive treatment. 4. Patients must have normal renal function test and no prior renal disease: The screening cut off for serum creatinine \< upper limit of normal. 5. Patients must have normal hepatic function test and no prior liver disease: The screening results for total bilirubin must be \< 1.5 times the upper limit of normal. The screening results for the following must be \< 2 times the upper limit of normal for patients to be eligible: Alkaline phosphatase (ALP) and Alanine aminotransferase (ALT). The screening results for Aspartate aminotransferase (AST) must be \< 2 times the upper limit of normal if available. 6. Patients who speak English (due to the novel research and its complexity, we are only accruing English speaking patients to the protocol). 7. Patients must be willing to discontinue taking dong quai and/or St John's wort. 8. Patients must be willing and able to review, understand, and provide written consent. Exclusion Criteria: 1. Patients receiving concurrent chemotherapy or concurrent biologic agent. 2. Patients who are taking medications or have conditions that potentially preclude use of any study medications or interventions as determined by the treating physician. 3. Patients who are enrolled in another symptom management trial or receiving active treatment under another clinical trial. 4. Bile duct obstruction or cholelithiasis. 5. History of clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, including multiple allergies or drug reaction. 6. Pre-existing psychosis or bipolar disorder. 7. Hypersensitivity to any tetracyclines. 8. Patients on anticoagulants (ie warfarin/heparin). 9. Patients with INR \> 1.5. 10. Patients taking any tetracycline within the last 15 days. 11. Patients that are pregnant. 12. Patients treated with upfront radical surgery at the primary site (other than diagnostic tonsillectomy or excision).
References
Publications (0)
Data not yet available
No reference posted for this study.