Effects of a spleen peptide preparation as supportive therapy in inoperable head and neck cancer patients

Patients with inoperable head and neck cancer were treated with a spleen pe ptide preparation (Polyegra(R)) in a phase III randomized, placebo-controll ed double-blind study during chemotherapy (cisplatin(R) tin/carboplatin, 5- fluorouracil) to investigate further the efficacy of this peptide preparati on as supportive treatment under chemotherapy. Immunological changes as wel l as quality of life aspects were examined. Forty patients were included in this study. The peptide preparation had a significant stabilizing effect on the periphe ral blood lymphocyte status during chemotherapy cycles (Student t-test, p = 0.05) and tended to stabilize the shift of granulocyte count (Student t-te st, p = 0.18). In addition, the group receiving the verum showed a remarkab le stabilization of body weight (Mann-Whitney U-test, p = 0.17) during chem otherapy treatment and the generally observed Increase of fatigue-inertia d uring the chemotherapy cycles was significantly reduced (Student t-test, p = 0.01).