Minocycline Reduces Chemoradiation-Related Symptom Burden in Patients with Non–small Cell Lung Cancer: A Phase II Randomized Trial
Abstract
Purpose: In patients with non–small cell lung cancer (NSCLC), concurrent chemoradiation therapy (CRT) exacerbates a cluster of difficult-to-manage symptoms, especially cancer-related fatigue. Minocycline is a readily available, low-cost antibiotic with anti-inflammatory properties. We conducted a phase II randomized, double-blinded, placebo-controlled trial to investigate the effect of minocycline in reducing CRT-symptom burden in NSCLC. Methods and Materials: Patients with NSCLC scheduled to receive CRT provided consent and were randomized to receive either minocycline (100 mg twice daily) or a matching placebo during 6 to 7 weeks of CRT. Patient-reported fatigue and other symptoms were assessed on MD Anderson Symptom Inventory weekly from the start of CRT for 12 weeks. The primary outcome was 12-week (±2 days) area under the curve (AUC) for symptom burden, which was compared between treatment groups. Results: Forty of 49 enrolled patients (80%) were evaluable (19 on minocycline and 21 on placebo). There were no grade 3+ adverse events related to the study medication. Fatigue was significantly reduced in the minocycline group compared to placebo group during the 12-weeks trial period (AUC=31.2±14.2 vs. 45.0±20.9, P=0.011), with a large effect size (Cohen’s d=0.77). Pain (Cohen’s d=0.54) and shortness of breath (Cohen’s d=0.55) were also significantly reduced in the minocycline group (all P<0.05). Conclusion: Minocycline during CRT for NSCLC was feasible, had a low toxicity…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 49 participants or records.
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