Spots Global Cancer Trial Database for The Evaluation of Curative Effect on Treatment of Tumor Above Thalidomide Combined With Megestrol

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Trial Identification

Brief Title: The Evaluation of Curative Effect on Treatment of Tumor Above Thalidomide Combined With Megestrol

Official Title: Prospective Clinical Study of the Effect of Thalidomide Combined With Megestrol Acetate on Lymphocyte, Inflammatory Factor Regulation and Nutritional Status in Patients With Advanced Malignant Tumors

Study ID: NCT03777930

Conditions

Cancer, Therapy-Related

Interventions

Chemotherapy drugs

thalidomide and megestrol acetate

optimal support treatment

thalidomide and megestrol acetate

Study Description

Brief Summary: To observe the effect of thalidomide combined with megestrol acetate on lymphocyte, inflammatory factor regulation and nutritional status in patients with advanced malignant tumors.

Detailed Description: This study was to select 200 patients with advanced tumors with an estimated survival of ≥ 2 months. 50 patients were randomly assigned to each group. The patients were divided into chemotherapy group, chemotherapy combined with thalidomide and megestrol acetate group, The best supportive treatment group, the best supportive treatment combined with thalidomide and megestrol acetate group. The chemotherapy group and the best supportive treatment group were the control group. The combined group was administered continuously for 8 weeks according to thalidomide 100 mg qn po and megestrol acetate 0.16 qd po. Calculating the sum of the longest diameters of the target lesions from each patient before and 8 week after treatment. Patients in each group before treatment, 4th week, and 7th week were observed T cell subsets, B cell subsets, NK cell subsets and the expression of inflammatory cytokines. Through nutritional assessment Table (PG-SGA), Multidimensional Deficit Power Meter (MFSI-SF), Quality of Life Assessment Scale (EORTC QLQ-C30), Prognostic Assessment Form (GPS), Physical Status Assessment Form (ECOG) and lean body mass, upper arm muscle circumference and upper arm muscle area analysis of the effect of thalidomide combined with megestrol acetate on the nutritional status of patients with advanced cancer which reveal that thalidomide combined with megestrol acetate may improve the immune regulation and nutritional status of patients with advanced malignant tumors mechanism.