Pain, Appetite Loss And Fatigue In Patients With Locally Advanced Or Metastatic Pancreatic Cancer In A Randomized Controlled Trial With Mistletoe Extract.

Background Pain, appetite loss and fatigue are the most prominent symptoms in patients with locally advanced or metastatic pancreatic cancer. Quality of life has been assessed from these patients during a confirmatory randomized controlled trial on survival. Methods In a randomized study (ISRCTN70760582) 220 patients were evenly randomized to receive s.c. injections of ME (Iscador® Qu) in a dose-escalating manner from 0.01 mg up to 10 mg three times per week, or no antineoplastic therapy (control). All patients received best supportive care. The primary endpoint was 12-month OS. Secondary efficacy parameters were the QoL dimensions of the core questionnaire of the European Organization for Research and Treatment of Cancer assessed at baseline and month 1, 2, 3, 6, 9, and 12 including pain, appetite loss and fatigue. The difference of the mean of the post baseline values "dPBL" (month 1-12 after baseline) to the basline itself were calculated. Negative values indicate an improvement of the symptom. Differences of more than 20 points are of big clinical relevance. The results of pain were verified by the documentation by the consumption of analgesics and the results of appetite loss by body weight. Results Baseline characteristics were well balanced between the ME and control group. OS for ME versus control patients was 4.8 vs. 2.7 months (HR=0.49; p< 0.0001. Patients in the ME group gained weight (mean 3.53%) and control patients lost weight (-2.76%); group difference: 6.29 %. Conclusion ME therapy drastically improves pain, appetite loss and fatigue in patients with locally advanced or metastatic pancreatic cancer. The application of ME is safe and non-toxic and should become a standard in therapy of this devastating disease, where additional burdens of conventional therapies are not desired anymore. [ABSTRACT FROM AUTHOR]