Clinical trial · Interventional
Minocycline Study in Non Small Cell Lung Cancer (NSCLC) Patients for Chemoradiation Therapy
A Randomized, Placebo Controlled-Double Blind Study of Minocycline for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Non Small Cell Lung Cancer
- 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 side effects reported by patients with NSCLC who are receiving chemoradiation therapy. In this study, minocycline will be compared to a placebo. Minocycline is an antibiotic that may help to reduce side effects of chemoradiation therapy. A placebo is not a drug. It looks like the study drug but 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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Minocycline | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Minocycline
- description
- Two-arm, placebo-controlled pilot study to obtain preliminary estimates of treatment effects of minocycline in patients with non small cell lung cancer (NSCLC) being consented for concurrent chemoradiation (CXRT). Minocycline 100 mg capsules taken by mouth two times a day every day for 7 weeks, starting on the first week of chemoradiation therapy. Questionnaires at baseline, timepoints during chemoradiation, and at treatment completion for 12 weeks.
- interventionNames
- Drug: Minocycline
- Behavioral: Questionnaires
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Two-arm, placebo-controlled pilot study to obtain preliminary estimates of treatment effects of minocycline in patients with non small cell lung cancer (NSCLC) being consented for concurrent chemoradiation (CXRT). Placebo capsules taken by mouth two times a day every day for 7 weeks, starting on the first week of chemoradiation therapy. Questionnaires at baseline, timepoints during chemoradiation, and at treatment completion for 12 weeks.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with a pathologically proven diagnosis of NSCLC and consented to receive CXRT at MD Anderson 2. Patients \> or = 18 years old 3. Patients who will receive CXRT with platinum/taxane-based chemotherapy and with a total radiation dose of \>or = 50 Gy, per treating physician's assessment 4. Patients who speak English or Spanish (due to MDASI language options, we are only accruing English-speaking or Spanish-speaking patients to the protocol) 5. Patients willing and able to review, understand, and provide written consent before starting therapy 6. Patients with normal renal function according to MD Anderson testing standards and no prior renal disease \[screening cut off for serum creatinine \< 1.5 times ULN\] 7. Patients must have the following screening results for hepatic function according to MD Anderson testing standards: total bilirubin \< 1.5 times the upper limit of normal; alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST - if available) must be \< 2 times the upper limit of normal Exclusion Criteria: 1. Patients with a history of clinically significant cutaneous drug reaction to minocycline, as documented in the patient medical records 2. Patients who are enrolled in other symptom management or symptom clinical trials 3. Patients who currently have bile duct obstruction or cholelithiasis 4. Patients with hypersensitivity to any tetracyclines 5. Patients who are pregnant; pregnancy will be confirmed by negative urine test 6. Patients on vitamin K antagonist warfarin
References
Publications (0)
Data not yet available