TITLE:
A pilot double-blind, randomized, placebo-controlled trial of curcumin/bioperine for lung cancer chemoprevention in patients with chronic obstructive pulmonary disease
AUTHORS:
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
KEYWORDS:
Lung Cancer; Inflammation; Nutraceutical Agents; COPD; Cytological Abnormalities
JOURNAL NAME:
Advances in Lung Cancer,
Vol.2 No.3,
August
1,
2013
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.