A pilot double-blind, randomized, placebo-controlled trial of curcumin/bioperine for lung cancer chemoprevention in patients with chronic obstructive pulmonary disease

Amir Sharafkhaneh, J. Jack Lee, Diane Liu, Ruth Katz, Nancy Caraway, Cherise Acosta, Ignacio I. Wistuba, Bharat Aggarwal, Burton Dickey, Seyed J. Moghaddam, Nicola Hanania, Robert Newman, Hanan Abdel-Monem, Nga Bich Nguyen, Carol J. Farhangfar, Waun K. Hong, Jonathan M. Kurie

Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, USA.
Department of Experimental Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, USA.
Department of Medicine, Baylor College of Medicine, Houston, USA.
Department of Pathology, The University of Texas MD Anderson Cancer Center, Houston, USA.
Department of Pulmonary Medicine, The University of Texas MD Anderson Cancer Center, Houston, USA.
Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, USA.
Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, USA.

DOI: 10.4236/alc.2013.23008                

Abstract

Chronic obstructive pulmonary disease is an inflammatory condition with increased risk of lung cancer. We hypothesized that curcumin/ bioperine (CB), which has anti-inflammatory effects, may reduce cytological abnormalities in the sputum of patients with COPD. We conducted a 3-month, three-to-one randomized, doubleblind, pilot trial of escalating doses of CB in patients with moderate or worse COPD who were capable of producing sputum. The primary efficacy endpoint was changed in sputum cytology. We also explored changes in fluorescence in situ hybridization (FISH). We obtained sputum samples for cytology and chromosome abnormalities at baseline and each monthly follow-up visit. We enrolled 57 participants, with 35 completing the study. The participants’ mean age (standard deviation [SD]) was 66.6 (8.2) years, and they were mainly male (91.2%), with an average of 63.8 pack-years of smoking history. Also, 42.1% of participants were active smokers and the mean (SD) FEV1 was 37% (13%). At baseline, 13 subjects had moderate or worse dysplasia (22.8%). Subjects with moderate to severe sputum dysplasia had more chromosome abnormalities in epithelial cells and neutrophils, as measured by deletion and aneuploidy in 10q22.3. The changes in sputum cytology and chromosome abnormalities did not differ between the active and placebo arms. CB was well tolerated at the bid doses of 1, 1.5, and 2 gm of curcumin and 5 mg of bioperine, with minor side effects related to the gastrointestinal tract. In this short pilot trial, CB compared to placebo did not alter cytological and chromosomal abnormalities seen in sputum of patients with COPD.

Keywords

Lung Cancer; Inflammation; Nutraceutical Agents; COPD; Cytological Abnormalities

Conflicts of Interest

The authors declare no conflicts of interest.

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