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 antiinflammatory properties. We conducted a phase 2 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 receiveCRT 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 for symptom burden, which was compared between treatment groups. RESULTS:Forty of 49 enrolled patients (80%) were evaluable (19 onminocycline 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 with placebo group during the 12-week trial period (area under the curve = 31.2 ± 14.2 vs 45.0 ± 20.9, P = .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 < .05). CONCLUSIONS:Minocycline during CRT for NSCLC was feasible, had a low toxicity profile, and yielded a clinically and statistically significant positive signal in reducing symptom burden related to NSCLC and CRT. This study is a proof of concept so a larger trial in CRT patients is warranted.
RCT Entities:
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 antiinflammatory properties. We conducted a phase 2 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 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 with placebo group during the 12-week trial period (area under the curve = 31.2 ± 14.2 vs 45.0 ± 20.9, P = .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 < .05). CONCLUSIONS:Minocycline during CRT for NSCLC was feasible, had a low toxicity profile, and yielded a clinically and statistically significant positive signal in reducing symptom burden related to NSCLC and CRT. This study is a proof of concept so a larger trial in CRT patients is warranted.
Authors: Xin Shelley Wang; Qiuling Shi; Loretta A Williams; Li Mao; Charles S Cleeland; Ritsuko R Komaki; Gary M Mobley; Zhongxing Liao Journal: Brain Behav Immun Date: 2010-03-29 Impact factor: 7.217
Authors: Xin Shelley Wang; Qiuling Shi; Loretta A Williams; Ritsuko Komaki; Daniel R Gomez; Steven H Lin; Joe Y Chang; Michael S O'Reilly; Raza H Bokhari; James D Cox; Radhe Mohan; Charles S Cleeland; Zhongxing Liao Journal: J Pain Symptom Manage Date: 2016-02-16 Impact factor: 3.612
Authors: Deirdre R Pachman; Travis Dockter; Patricia J Zekan; Briant Fruth; Kathryn J Ruddy; Lauren E Ta; Jacqueline M Lafky; Todor Dentchev; Nguyet Anh Le-Lindqwister; William M Sikov; Nathan Staff; Andreas S Beutler; Charles L Loprinzi Journal: Support Care Cancer Date: 2017-05-27 Impact factor: 3.603
Authors: Xin Shelley Wang; Loretta A Williams; Sunil Krishnan; Zhongxing Liao; Ping Liu; Li Mao; Qiuling Shi; Gary M Mobley; Jeanie F Woodruff; Charles S Cleeland Journal: Brain Behav Immun Date: 2012-01-10 Impact factor: 7.217
Authors: B C Tilley; G S Alarcón; S P Heyse; D E Trentham; R Neuner; D A Kaplan; D O Clegg; J C Leisen; L Buckley; S M Cooper; H Duncan; S R Pillemer; M Tuttleman; S E Fowler Journal: Ann Intern Med Date: 1995-01-15 Impact factor: 25.391
Authors: Alon Scope; Anna Liza C Agero; Stephen W Dusza; Patricia L Myskowski; Jocelyn A Lieb; Leonard Saltz; Nancy E Kemeny; Allan C Halpern Journal: J Clin Oncol Date: 2007-12-01 Impact factor: 44.544
Authors: Xin Shelley Wang; Qiuling Shi; Tito R Mendoza; Araceli Garcia-Gonzalez; Ting-Yu Chen; Mona Kamal; Tsun Hsuan Chen; Cobi Heijnen; Robert Z Orlowski; Charles S Cleeland Journal: Support Care Cancer Date: 2021-04-01 Impact factor: 3.603