NCT03777930

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Shenzhen Fifth People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer, Therapy-Related

Interventions

Type	Name	Description
DRUG	Chemotherapy drugs	According to the NCCN Guidelines
DRUG	thalidomide and megestrol acetate	The thalidomide and megestrol acetate administration groups were administered with thalidomide 100 mg qn po and megestrol acetate 0.16 qd po for 8 weeks
OTHER	optimal support treatment	Patients who cannot tolerate chemotherapy and other cancer treatments receive optimal support for 8 weeks
DRUG	thalidomide and megestrol acetate	The thalidomide and megestrol acetate administration groups were administered with thalidomide 100 mg qn po and megestrol acetate 0.16 qd po for 8 weeks

Timeline

• Start date: 2018-12-10
• Primary completion: 2020-10-10
• Completion: 2021-06-10
• First posted: 2018-12-19
• Last updated: 2018-12-19