Phase I/II study of stage III and IV non-small cell lung cancer patients taking a specific dietary supplement.

ABSTRACT

This phase I/II study evaluates the influence of selected vegetables (SV) that contain known antitumor components on the survival of stage III-IV non-small cell lung cancer (NSCLC) patients. All patients were treated with conventional therapies. SV was added to the daily diet of 5 stage I patients in the toxicity study group (TG) and 6 stage III and IV patients in the treatment group (SVG), but not to the diet of 13 stage III and IV patients in the control group (CG). Age, Karnofsky performance status (KPS), and body mass index of SVG and CG patients were comparable at entry. KPS declined in the CG patients (79 +/- 8 to 55 +/- 11) but improved in the SVG patients (75 +/- 8 to 80 +/- 13) one to three months after entry. Weight change in the CG, SVG, and TG patients was -12 +/- 5%, -2 +/- 2%, and +4 +/- 4%, respectively. The median survival time and mean survival of the CG patients were 4 and 4.8 months, but in the SVG patients they were 15.5 and 15 months (p < 0.01). No clinical signs of toxicity were found in the TG patients in the 24-month study period. Adding SV to the daily diet of NSCLC patients was found to be nontoxic and associated with improved weight maintenance, KPS, and survival of stage III and IV NSCLC patients.