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.

Method: 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.

Conclusion: 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.

Figures

Figure 1

Changes in body weight relative to baseline (in percent; mean ± standard deviation) in patients with locally advanced or metastatic pancreatic cancer who underwent at least one follow-up examination (96 patients were treated with mistletoe, and 72 control patients were not). The percent changes from baseline were consistently different between the two groups in the mixed model both with and without interactions as well as in non-parametric, stratified analyses.

Figure 2

Changes on the 15 quality-of-life scales of the EORTC-QLQ-C30 questionnaire relative to baseline (mean ± standard deviation) in patients with locally advanced or metastatic pancreatic cancer who underwent at least one follow-up examination. 96 patients were treated with mistletoe, and 72 control patients were not. The increasingly pale connecting lines are meant to represent the diminishing number of patients, as seen in Table 4. The related data tables, along with a further representation stratified by time of death with corresponding data tables, can be found in the eSupplement, as can the raw data for the Figures.

eFigure

The distribution of patients with locally advanced or metastatic pancreatic carcinoma who received mistletoe treatment or belonged to the untreated control group