This is a randomized, double-blind parallel-group, placebo-controlled study. that will last 40 weeks and will focus on Quality of Life.36 Subjects with stage IV metastatic colorectal cancer will be referred for study inclusion. Patients will be randomly assigned (1:1 ratio) to take 2 ml of LentinexHP or placebo orally twice a day (a total of 6 mg). Products will be dispensed to allow administration of the product for six weeks. Each bottle of LentinexHP or placebo contains 30 mL, which at 1.5 mg/mL will provide dosage for approximately five days. The patients will periodically complete the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Quality of Life (QoL) instrument, the short form 36 (SF-36), the Fatigue Symptom Inventory (FSI), and the QoL questionnaire used in the previous LentinexHP QoL study.
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Primary Objective: * The primary objective of the study is to explore the effect of LentinexHP versus placebo as an add-on non-drug therapy to improve QoL in patients with stage IVmetastatic colorectal cancer.
Timeframe: 12 Weeks