Quality of Life is Improved in Breast Cancer Patients by Standardised Mistletoe Extract PS76A2 during Chemotherapy and Follow-up: A Randomised, Placebo-controlled, Double-blind, Multicentre Clinical Trial

• Published in: Anticancer research 2006-03, Vol.26 (2B), p.1519-1529
• Main Authors: SEMIGLAZOV, V. F, STEPULA, V. V, DUDOV, A, SCHNITKER, J, MENGS, U
• Format: Article
• Language: English
• Subjects: Adult; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Breast Neoplasms - drug therapy; Breast Neoplasms - surgery; Chemotherapy, Adjuvant; Cyclophosphamide - administration & dosage; Cyclophosphamide - adverse effects; Double-Blind Method; Female; Fluorouracil - administration & dosage; Fluorouracil - adverse effects; Follow-Up Studies; Humans; Methotrexate - administration & dosage; Methotrexate - adverse effects; Middle Aged; Placebos; Plant Preparations - administration & dosage; Plant Proteins - administration & dosage; Prospective Studies; Quality of Life; Ribosome Inactivating Proteins, Type 2; Toxins, Biological - administration & dosage
• ISSN: 0250-7005; 1791-7530

The objective of this randomised, multicentre, double-blind clinical trial was to investigate the impact of PS76A2, an aqueous mistletoe extract standardised to mistletoe lectins, on quality of life (QoL) in breast cancer patients. A total of 352 patients were randomly allocated to 2 groups receiving PS76A2 (15 ng mistletoe lectin/0.5 ml) or matching placebo twice weekly for 4 to 6 cycles of CMF (cyclophosphamide, methotrexate, fluorouracil) chemotherapy followed by 2 months follow-up. The primary efficacy end-point was the change from baseline of 3 FACT-G subscales (physical, emotional and functional well-being) during the fourth CMF cycle. Secondary measures included GLQ-8 (8 linear analogue self-assessment scales), Spitzer's uniscale and haematological variables. The main variables of safety analysis were adverse events, including injection site reactions and clinical laboratory tests. The results showed that physical, emotional and functional well-being improved upon PS76A2, but deteriorated following placebo. The treatment differences were statistically significant for the 3 subscales as well as for the summary score FACT-G, which was analysed as O'Brien's rank sum of its 3 subscales. The total score increased by 4.40±11.28, indicating a higher QoL after PS76A2, but decreased by 5.11±11.77 with placebo (p