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Sample size and inclusion and exclusion criteria for this study were based on previous investigations having a comparable study design (21)

Sample size and inclusion and exclusion criteria for this study were based on previous investigations having a comparable study design (21). Inclusion criteria Individuals with an age between 18 and 70; stage II/III/IV malignant tumor; histologically confirmed malignant tumor, with or without grade I/II A 839977 bone marrow suppression after receiving chemotherapy; no prior radiotherapy; adequate bone marrow reserve (HGB 90 g/L, complete NEU 1.5109/L and PLT 100109/L) hepatic A 839977 function (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 2.5 upper normal limits, total bilirubin 1.25 upper normal limits), and renal function (creatinine clearance 60 mL/min); an Eastern Cooperative Oncology Group overall performance score 2; generally good health and more than 3 years remaining life expectancy. Exclusion criteria Individuals demonstrating pregnancy or lactation; evidence of central nervous system metastasis; additional serious non-cancer main diseases (e.g., cardiovascular disease, cerebrovascular system disease, hematopoietic system disease, hepatic and nephric insufficiency, psychiatric disorders, and additional severe medical conditions as judged from the investigators); grade III/IV bone marrow suppression after receiving chemotherapy. useful properties of Spirulina. Pugh reported that oral administration of Immulina, a commercial draw out from Spirulina, can reduce the severity of influenza A (H1N1) viral illness in mice model by activating innate immune cells (10). Additional research has shown that Spirulina can enhance innate immunity in mice and inhibit tumor growth by modulating the balance between interleukin (IL)-17/IL-23 and interferon (IFN)- (11). An investigation in seniors Korean participants found that Spirulina supplementation may influence the manifestation of inflammatory markers like IL-2 and tumor necrosis element (TNF)- through monocyte chemotactic protein-1 (MCP-1), suggesting that Spirulina is useful for improving immune function A 839977 (12). Spirulina has also been widely applied to patients with human being immunodeficiency computer virus (HIV). Randomized, single-blind studies showed that Spirulina could improve the nutritional status of malnourished HIV individuals, leading to a significant increase in CD4+ cells and related decrease in viral weight (13,14). Moreover, Spirulina was reported to promote proliferation of human being neural stem cells and hematopoietic stem cells through its immunomodulatory effects (15,16). Selmi found that Spirulina supplementation could help to increase corpuscular hemoglobin and ameliorate anemia and immunosenescence in older individuals (17). A related study concluded that Spirulina in combination with standard iron-folic acid supplementation can bring about impressive improvements in individuals with nutritional anemia (18). In addition, some investigations have also reported the protecting effects of diet Spirulina within the hepatic swelling caused by ageing or toxicants (19,20). These studies exposed the anti-inflammatory, antioxidant and antihepatotoxic effects of Spirulina. Although the immune function and antioxidant effects of Spirulina are well supported in individuals with viral infections and anemia, limited studies have assessed its immunomodulatory effects in cancer individuals receiving chemotherapy. To address this shortcoming, we performed a medical trial to evaluate the effectiveness of Spirulina as an adjunct to chemotherapy to improve immune function and reduce myelosuppression in individuals with malignant tumors. Methods Participants From May 2017 to April 2018, 100 individuals with malignant tumors undergoing chemotherapy under the supervision of the Oncology Division of Beijing Chao-Yang Hospital qualified to be included in the study. The research was carried out according to the principles set out in the Declaration of Helsinki 1964. The study protocol was authorized by the Human being Ethics Committee of Beijing Chao-Yang Hospital A 839977 (2017-ke-313) and knowledgeable consent was from all participants. Sample size and inclusion and exclusion criteria for this study were based on earlier investigations having a similar study design (21). Inclusion criteria Individuals with an age between 18 and 70; stage II/III/IV malignant tumor; histologically confirmed malignant tumor, with or without grade I/II bone marrow suppression after receiving chemotherapy; no prior radiotherapy; adequate bone marrow reserve (HGB 90 g/L, complete NEU 1.5109/L and PLT 100109/L) hepatic function (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 2.5 upper normal limits, total bilirubin 1.25 upper normal limits), and renal function PPP1R49 (creatinine clearance 60 mL/min); an Eastern Cooperative Oncology Group overall performance score 2; generally good health and a lot more than 3 years remaining life expectancy. Exclusion criteria Individuals demonstrating pregnancy or lactation; evidence of central nervous system metastasis; additional serious non-cancer main diseases (e.g., cardiovascular disease, cerebrovascular system disease, hematopoietic system disease, hepatic and nephric insufficiency, psychiatric disorders, and additional severe medical conditions as judged from the investigators); grade III/IV bone marrow suppression after receiving chemotherapy. Additionally, individuals undergoing treatment with investigational medicines were excluded. Treatment protocol Patients were randomly divided into treatment and control organizations relating to a random number table. Spirulina was from InM Wushenzhao Ecological Development Co., Ltd. (suppliers developing lot Quantity: 020602B01) and the dose included 3 pills of 100 mg each given 3 times daily with meals. Individuals in the treated group consumed Spirulina during the 1st two cycles of routine chemotherapy. The control group did not consume Spirulina pills or additional drugs comprising Spirulina during chemotherapy. All individuals completed four cycles of personalized chemotherapy regimens. Data collection The characteristics of all individuals were collected, including: gender, age, main tumor, tumor metastasis, duration of chemotherapy, and treatment protocol for each cycle. The primary performance end point of this study was evaluated by detecting bone marrow suppression between the two organizations in each cycle, including routine blood tests [white blood cell (WBC), neutrophilic granulocyte (NEU), hemoglobin (HGB) and platelet (PLT)], and myelosuppression-related adverse events (treatment A 839977 of leukopenia, IIICIV grade bone marrow suppression and alteration of chemotherapy). The lowest ideals of WBC, NEU, HGB and PLT were included in the analysis if there was more than one routine blood test in each cycle. The switch in the results of the routine blood test across cycles was determined using the method: dn = baseline ? Cyclen. The secondary end-point was assessed.