Tröger, W., Jezdic, S., Zdrale, Z., Tisma, N., Hamre, H.J., & Matijasevic, M. (2009). Quality of life and neutropenia in patients with early stage breast cancer: A randomized pilot study comparing additional treatment with mistletoe extract to chemotherapy alone. Breast Cancer, 3, 35–45.
The purpose of this article was to determine the clinical response identified as quality of life, including fatigue and neutropenia, in patients receiving CAF for breast cancer with additional treatment with mistletoe extract compared to chemotherapy alone.
Ninety-five patients were randomized into three groups. All patients received chemotherapy with six cycles of chemotherapy with cyclophosphamide, adriamycin, and 5-flourouracil (CAF). Two groups also received Iscador administered by subcutaneous injection, containing 1 ml of varying amounts of fermented extract of fresh mistletoe herb or a different mistletoe preparation. IMS was incrementally increased from 0.01–5 mg of the herb in isotonic saline. The control group (n = 31) was compared to group who received IMS (n = 30). The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QOQ-C30) was used to assess quality of life, including fatigue. An absolute neutrophil count of less than 1,000 mcl defined neutropenia and was assessed at baseline and one day prior to each cycle of CAF chemotherapy.
A single-site oncology and radiology institute in Belgrade, Serbia
Prospective, randomized, open-label pilot
Quality of life decreased from baseline in all scores of control group participants and in six scores in the IMS group. The most significant decreases in scores were seen for nausea/emesis (17.2 score points) and fatigue (8.2 score points) following the second cycle of CAF chemotherapy. Decreases in insomnia (13.1 score points) and diarrhea (11.9 score points) were reported after the third cycle of CAF chemotherapy.
An adjusted analyses that compared mean differences from baseline of the control and IMS groups revealed that all 15 comparisons favored the IMS group, 12 comparisons showed significant differences (p = 0.017–0.001). The IMS group were favored over the control group, with a clinically relevant differences of 5 points or more for nine of the EORTC-QLQ-C30 scores. Statistically significant improvement in symptoms with IMS compared to controls were found for physical functioning, role functioning, emotional functioning, social functioning, fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, diarrhea, and financial difficulties
Neutropenia was identified three times in three different patients within the IMS group and nine times in eight different patients of the control group. Odds ratio for the proportion of patients with neutropenia in IMS group versus control group was 0.32 (95% CI [0.08, 1.35]).
Localized skin reactions to IMS occurred in six patients. No other adverse events were reported, and findings with use of the other mistletoe preparation are not reported.
For patients receiving CAF chemotherapy for early stage-breast cancer, adding mistletoe therapy improved quality of life and demonstrated a trend toward reduction of neutropenia.
Findings suggest that mistletoe might have some applicability in managing symptoms for patients with cancer, and may have an effect on neutropenia. Findings of this study are severely effected by limitations in study design and the small sample size that makes meaningful analysis of some outcomes of interest difficult. As a result, this study does not provide strong support for efficacy of mistletoe use.