The immunomodulation and quality of life improvement of Ganoderma lucidum spore powder on Cancer patient(2019)

2023-02-24

The 10^th International Medicinal Mushroom Conference

Abstract

To evaluate the efficacy of Sporoderm-broken Ganoderma lucidum spore powder as adjuvant therapy for cancer patients undergoing chemotherapy. In this prospective multi-center and open-label phase IV clinical trial, patients were randomized to 2 groups, Control group (CG group) and Sporoderm-broken Ganoderma lucidum spore powder group (SG group). The inclusion criteria were: patients with non-small cell lung cancer or breast cancer confirmed by pathology; ECOG (Eastern Cooperative Oncology Group, ECOG) performance status of 0 ~ 1; written informed consent. The exclusion criteria were: age <18 or >70 years old, systemic disease believed by the attending physician to present ≥ 3 months mortality. The primary outcome was Serum cytokines expression panels, which were evaluated after 42 days therapy. The secondary outcome was quality of life improvement defined by ECOG performance status and EORTC QLQ-C30, which were evaluated both at day 21 and day 42. The adverse events were recorded and analyzed. From Nov 2015 to Oct 2016, 240 patients were randomized to SG group (n= 120) and CG group (n=120), 185 patients finished 42 days therapy and follow-up. Patient baseline characteristics, protocol of chemotherapy and TNM stages are summarized in table 1 and do not show clinically important differences among the two groups. Compared with CG group, only IL-2 was upregulated in SG group. No difference was seen among the two groups on ECOG performance status and EORTC QLQ-C30 at day 21 and day 42. Totally, myelosuppression(n=21, 4.8%) and granulocytic deficiency(n=10, 2.08%) were related to chemotherapy, and no difference among the two groups. Vital signs, urine analysis, blood chemistry, EKG showed no clinical significance compared with baseline. No other new adverse events were seen during the study. Conclusion：1. Sporoderm-broken spores of Ganoderma lucidum exhibit positive efficacy of immunological modulation ,with respect to the upregulation of expression level of cancer-related cytokines, which may potentially enhance the antineoplastic immunity；2.The safety profile is acceptable when edible Sporoderm-broken Ganoderma lucidum spore powder used as the adjuvant therapy for lung cancer or breast cancer patients undergoing chemotherapy；3. No quality improvement is seen among the two groups at day 21 and day42.

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