title: Quality of life of patients with advanced pancreatic cancer during treatment with mistletoe: a randomized controlled trial.
abstract: BACKGROUND
  The treatment of cancer patients with mistletoe extract is said to prolong their survival and, above all, improve their quality of life. We studied whether the quality of life of patients with advanced pancreatic cancer could be improved by mistletoe extract.
  
  
  METHODS
  An open, single-center, group-sequential, randomized phase III trial (ISRCTN70760582) was conducted. From January 2009 to December 2010, 220 patients with locally advanced or metastatic pancreatic cancer who were receiving no further treatment for pancreatic cancer other than best supportive care were included in this trial. They were stratified by prognosis and randomly allocated either to a group that received mistletoe treatment or to one that did not. Mistletoe extract was given in escalating doses by subcutaneous injection three times a week. The planned interim evaluation of data from 220 patients indicated that mistletoe treatment was associated with longer overall survival, and the trial was terminated prematurely. After termination of the study, the results with respect to quality of life (assessed with the QLO-C30 scales of the European Organisation for Research and Treatment of Cancer) and trends in body weight were evaluated.
  
  
  RESULTS
  Data on quality of life and body weight were obtained from 96 patients treated with mistletoe and 72 control patients. Those treated with mistletoe did better on all 6 functional scales and on 7 of 9 symptom scales, including pain (95% confidence interval [CI] -29 to -17), fatigue (95% CI -36.1 to -25.0), appetite loss (95% CI -51 to -36.7), and insomnia (95% CI -45.8 to -28.6). This is reflected by the trend in body weight during the trial.
  
  
  CONCLUSIONS
  In patients with locally advanced or metastatic pancreatic carcinoma, mistletoe treatment significantly improves the quality of life in comparison to best supportive care alone. Mistletoe is an effective second-line treatment for this disease.
authors.affiliation: Clinical Research Dr. Tröger, Freiburg.
authors.forename: Wilfried
authors.initials: W
authors.lastname: Tröger
authors.affiliation: First Surgical Clinic of the Clinical Centers of Servia (Belgrade).
authors.forename: Danijel
authors.initials: D
authors.lastname: Galun
authors.affiliation: Institute for Clinical Research, Berlin.
authors.forename: Marcus
authors.initials: M
authors.lastname: Reif
authors.affiliation: Institute for Clinical Research, Berlin.
authors.forename: Agnes
authors.initials: A
authors.lastname: Schumann
authors.affiliation: CLINICOBSS, Niš, Serbia.
authors.forename: Nikola
authors.initials: N
authors.lastname: Stanković
authors.affiliation: Faculty of Medicine, University of Belgrade, Serbia.
authors.forename: Miroslav
authors.initials: M
authors.lastname: Milićević
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015984:Causality; D015897:Comorbidity; D006801:Humans; D008875:Middle Aged; D014784:Mistletoe / Q000737:chemistry*; D010146:Pain / Q000453:epidemiology* / Q000517:prevention & control / Q000523:psychology; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000523:psychology*; D008517:Phytotherapy / Q000379:methods*; D010936:Plant Extracts / Q000627:therapeutic use*; D015995:Prevalence; D011788:Quality of Life / Q000523:psychology*; D012307:Risk Factors; D055771:Serbia / Q000453:epidemiology; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D010936:Plant Extracts