Introduction
cancer, tumor, Tumor, pain
TUMOR, TUMOR, CANCER, DISEASE, SOLID TUMOR, HAND SWELLING, CYTOTOXICITY
Patients with cancer experience physical impairment and a decline in quality of life (QoL) related to disease and therapy. The use of complementary medicine to support treatment and improve QoL has been increasingly popular, rising from 25% of patients in the 1970s to 50% by 2000 (Preparations from ME are the most frequently prescribed complementary medicine in cancer treatment in German-speaking countries, either as a sole treatment or during chemotherapy or radiotherapy (Traditional ME therapy is administered subcutaneously, but local subcutaneous injection is limited because of pain and swelling at the injection site (There are three types of ME, Helixor-P (pine trees), Helixor-M (apple trees), and Helixor-A (fir trees; ref. In light of the preclinical cytotoxicity of Helixor-M, its widespread use, yet controversial efficacy, and especially the lack of safety data for its intravenous administration, this phase I trial (ClinicalTrials.gov identifier: NCT03051477) tested intravenous Helixor-M in patients with solid tumor to determine its safety and MTD. Tumor responses, serum cytokines, tumor markers, and QoL were also measured.