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

NCT ID: NCT03777930

Last Updated: 2018-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-10

Study Completion Date

2021-06-10

Brief Summary

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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

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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

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Cancer, Therapy-Related

Keywords

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thalidomide megestrol acetate tumor lymphocyte inflammatory cytokines nutritional

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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chemotherapy group

the patients were recepted chemotherapy alone

Group Type EXPERIMENTAL

Chemotherapy drugs

Intervention Type DRUG

According to the NCCN Guidelines

chemotherapy combined with TH and MG group

the patients were recepted chemotherapy combined with thalidomide and megestrol

Group Type EXPERIMENTAL

thalidomide and megestrol acetate

Intervention Type DRUG

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

the best supportive treatment group

the patients were recepted the best supportive without chemotherapy

Group Type EXPERIMENTAL

optimal support treatment

Intervention Type OTHER

Patients who cannot tolerate chemotherapy and other cancer treatments receive optimal support for 8 weeks

the best supportive treatment combined with TH and MG group

the patients were recepted the best supportive combined with thalidomide and megestrol without chemotherapy

Group Type EXPERIMENTAL

thalidomide and megestrol acetate

Intervention Type DRUG

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

Interventions

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Chemotherapy drugs

According to the NCCN Guidelines

Intervention Type 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

Intervention Type DRUG

optimal support treatment

Patients who cannot tolerate chemotherapy and other cancer treatments receive optimal support for 8 weeks

Intervention Type OTHER

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

Intervention Type DRUG

Other Intervention Names

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Chemotherapy drugs optimal support treatment

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shenzhen Fifth People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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yangwei w yang, master

Role: CONTACT

Phone: 13826524554

Email: [email protected]

wenbin wb gao, doctor

Role: CONTACT

Phone: 13266778968

Email: [email protected]

Other Identifiers

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shenzhenfifth 201807

Identifier Type: -

Identifier Source: org_study_id