BACKGROUND: It is assumed that perioperative immunomodulation of cancer patients can attenuate cellular and humoral deficiencies thus improving their overall health status. Mistletoe (Viscum album L.) anticancer drugs are likely candidates for such adjuvant therapy, because they do not have major adverse side-effects but have dual desirable activities; immune-modulating effects and relatively selective cytotoxicity for cancer cells. MATERIALS AND METHODS: We used the aqueous extract Isorel, which is produced from the entire plant and is validated for batch consistency. The study involved 70 cancer patients, divided into two groups: Isorel-treated group of 40 patients who received Isorel for 2 pre- and 2 post-operative weeks (1 esophageal, 16 gastric, 2 pancreatic and 21 colorectal carcinomas) and the age- and sex-matched control group of 30 patients that did not receive Isorel (2 esophageal, 9 gastric, 3 pancreatic, 1 ileac and 15 colorectal carcinomas). Blood samples were obtained to study parameters of the immune system before the surgery and the drug administration (DO) and on the postoperative days 1 and 14 (D1, D14). The overall health status was evaluated after 60 days by the Kamofsky Performance Index and by the Analogic Scale of Anxiety. The results were compared by Student's t-test and one-way ANOVA test. RESULTS: Isorel significantly attenuated the immuno-suppressive effects of surgery observed for the Isorel-treated group, increasing the number of NK cells, the T and B cells, in particular T-helper cells, complement, IgA, IgG and IgM values also in comparison to the respective D0 values. Both the Kamofsky status and the Anxiety Scale improved remarkably in Isorel-treated patients in comparison to the control. CONCLUSION: The results of this study indicate that perioperative use of the mistletoe drug Isorel can improve immune competence and the overall health status of cancer patients undergoing surgery.
RCT Entities:
BACKGROUND: It is assumed that perioperative immunomodulation of cancerpatients can attenuate cellular and humoral deficiencies thus improving their overall health status. Mistletoe (Viscum album L.) anticancer drugs are likely candidates for such adjuvant therapy, because they do not have major adverse side-effects but have dual desirable activities; immune-modulating effects and relatively selective cytotoxicity for cancer cells. MATERIALS AND METHODS: We used the aqueous extract Isorel, which is produced from the entire plant and is validated for batch consistency. The study involved 70 cancerpatients, divided into two groups: Isorel-treated group of 40 patients who received Isorel for 2 pre- and 2 post-operative weeks (1 esophageal, 16 gastric, 2 pancreatic and 21 colorectal carcinomas) and the age- and sex-matched control group of 30 patients that did not receive Isorel (2 esophageal, 9 gastric, 3 pancreatic, 1 ileac and 15 colorectal carcinomas). Blood samples were obtained to study parameters of the immune system before the surgery and the drug administration (DO) and on the postoperative days 1 and 14 (D1, D14). The overall health status was evaluated after 60 days by the Kamofsky Performance Index and by the Analogic Scale of Anxiety. The results were compared by Student's t-test and one-way ANOVA test. RESULTS: Isorel significantly attenuated the immuno-suppressive effects of surgery observed for the Isorel-treated group, increasing the number of NK cells, the T and B cells, in particular T-helper cells, complement, IgA, IgG and IgM values also in comparison to the respective D0 values. Both the Kamofsky status and the Anxiety Scale improved remarkably in Isorel-treated patients in comparison to the control. CONCLUSION: The results of this study indicate that perioperative use of the mistletoe drug Isorel can improve immune competence and the overall health status of cancerpatients undergoing surgery.