Clinical trial NCT03777930: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cancer, Therapy-Related
Keywords: thalidomide
megestrol acetate
tumor
lymphocyte
inflammatory cytokines
nutritional
Lead sponsor: Shenzhen Fifth People's Hospital
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 200 patients with advanced tumors with a predicted survival period of ≥2 months were selected, including 100 patients with chemotherapy indications (50 patients were divided into chemotherapy group and 50 patients were divided into chemotherapy combined with TH and MG group according to the random principle) and 100 patients without chemotherapy indications (50 patients were randomly divided into the best supportive treatment group and 50 patients were randomly divided into the best supportive treatment group with TH and MG according to the random principle). The chemotherapy alone group and the best supportive treatment group were the control group. 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Patients with advanced malignant tumor confirmed by histopathology or cytology (hepatocarcinoma can be clinical diagnosis)
* Must be able to swallow pills
* The age of the tester ≥ 18 years old
* Gender is not limited
* Kamofsky score \> 20 points
* Estimated survival period ≥ 2 months
* Childbearing age Women need negative pregnancy test
* Patients voluntarily sign informed consent and receive follow-up
* The tester can cooperate to observe adverse events and efficacy
* All of the above conditions can be included

Exclusion Criteria:

* Active upper digestive tract ulcers, obvious vomiting, chronic diarrhea, intestinal obstruction, malabsorption, etc; other patients have been known to affect drug absorption, distribution, metabolism or clearance
* 2 or more important organ dysfunction
* Thrombosis Embolism history, except for thrombosis caused by PICC
* Patients suspected of having a history of allergy to thalidomide tablets
* Any significant clinical and laboratory abnormalities that researchers believe affect safety evaluators, such as: uncontrollable activity Microbial infection, grade II or above peripheral neuropathy (NCI CTC AE v4.0), congestive heart failure, myocardial infarction within 6 months, chronic kidney disease, thyroid dysfunction etc, and acceptance may bring significant metabolic or weight changes Patients with clinical disposition
* Patients with mental disorders, affecting the efficacy of the assessor
* During the trial period and within 3 months after the end of the trial, the subject and his partner are not willing to contraception
* Any of the above can not be enrolled.

Primary outcomes:
measure: Imaging efficacy evaluation
timeFrame: before and 8 week after treatment
Secondary outcomes:
measure: Observing the expression of lymphocyte subsets
timeFrame: before , the fourth and the seventh weeks of treatment
measure: Observing the expression of inflammatory factors
timeFrame: before , the fourth and the seventh weeks of treatment
measure: Nutritional assessment
timeFrame: before , the fourth and the seventh weeks of treatment
Other outcomes:
measure: Multidimensional deficient power assessment
timeFrame: before , the fourth and the seventh weeks of treatment
measure: Quality of life assessment
timeFrame: before , the fourth and the seventh weeks of treatment
measure: Prognostic assessment
timeFrame: before , the fourth and the seventh weeks of treatment
measure: Performance status assessment
timeFrame: before , the fourth and the seventh weeks of treatment
measure: Lean body mass
timeFrame: before , the fourth and the seventh weeks of treatment
measure: Upper arm muscle circumference and upper arm muscle area
timeFrame: before , the fourth and the seventh weeks of treatment
Locations:
Study officials:
References: