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

Primary Purpose

Cancer, Therapy-Related

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Chemotherapy drugs
thalidomide and megestrol acetate
optimal support treatment
thalidomide and megestrol acetate
Sponsored by
Shenzhen Fifth People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer, Therapy-Related focused on measuring thalidomide, megestrol acetate, tumor, lymphocyte, inflammatory cytokines, nutritional

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    chemotherapy group

    chemotherapy combined with TH and MG group

    the best supportive treatment group

    the best supportive treatment combined with TH and MG group

    Arm Description

    the patients were recepted chemotherapy alone

    the patients were recepted chemotherapy combined with thalidomide and megestrol

    the patients were recepted the best supportive without chemotherapy

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

    Outcomes

    Primary Outcome Measures

    Imaging efficacy evaluation
    Clinical response Based on the Response Evaluation Criteria Solid Tumors (RECIST), the therapeutic effect was divided into complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD). Investigators calculate the sum of the longest diameter of the target lesions from each patient by CT or MRI.

    Secondary Outcome Measures

    Observing the expression of lymphocyte subsets
    Patients were detected Lymphocyte subgroups of 2 ml peripheral blood by Flow cytometer (BD FACSCalibur), which inclunde the T cell subsets, NK cell subset, B cell subset(percentage)
    Observing the expression of inflammatory factors
    2 ml of peripheral blood was taken from each patient. Flow cytometry was used to detect changes of inflammatory factor expression which include the IL-2, IL- 4, IL-5, IL-6, IL-9, IL-10, IL-13, IL-17A, IL-17F, IL-21, IL-22, IFN-γ and TNF-α(ug/ml)
    Nutritional assessment
    Scored Patient-Generated Subjiective Global Assessment（PG-SGA）form was used in the present study. The total score of PG-SGA is summed by the following four subscale scores（A+B+C+D）. The first measurement score（A）is self-assessed by the subject and consists of the following four parts: Weight Table（0-4），Eating Situation Table（0-6），Symptom Table （0-22），Activity and Body Function Table（0-3）. The remaining three measurements are completed by trained registered clinical physicians， dieticians，and nurses: Scale of relationship between disease and nutritional needs（B）（0-6），Metabolic demand scale（C）（0-9），Physical examination scale（D）（0-24）. The scoring was controlled by one researcher (H.R). The lower scores represent a better outcome and the higher scores represent a worse outcome.

    Full Information

    First Posted
    August 25, 2018
    Last Updated
    December 12, 2018
    Sponsor
    Shenzhen Fifth People's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03777930
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 10, 2018 (Anticipated)
    Primary Completion Date
    October 10, 2020 (Anticipated)
    Study Completion Date
    June 10, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shenzhen Fifth People's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cancer, Therapy-Related
    Keywords
    thalidomide, megestrol acetate, tumor, lymphocyte, inflammatory cytokines, nutritional

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    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.
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    chemotherapy group
    Arm Type
    Experimental
    Arm Description
    the patients were recepted chemotherapy alone
    Arm Title
    chemotherapy combined with TH and MG group
    Arm Type
    Experimental
    Arm Description
    the patients were recepted chemotherapy combined with thalidomide and megestrol
    Arm Title
    the best supportive treatment group
    Arm Type
    Experimental
    Arm Description
    the patients were recepted the best supportive without chemotherapy
    Arm Title
    the best supportive treatment combined with TH and MG group
    Arm Type
    Experimental
    Arm Description
    the patients were recepted the best supportive combined with thalidomide and megestrol without chemotherapy
    Intervention Type
    Drug
    Intervention Name(s)
    Chemotherapy drugs
    Intervention Description
    According to the NCCN Guidelines
    Intervention Type
    Drug
    Intervention Name(s)
    thalidomide and megestrol acetate
    Other Intervention Name(s)
    Chemotherapy drugs
    Intervention Description
    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
    Other
    Intervention Name(s)
    optimal support treatment
    Intervention Description
    Patients who cannot tolerate chemotherapy and other cancer treatments receive optimal support for 8 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    thalidomide and megestrol acetate
    Other Intervention Name(s)
    optimal support treatment
    Intervention Description
    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 Outcome Measure Information:
    Title
    Imaging efficacy evaluation
    Description
    Clinical response Based on the Response Evaluation Criteria Solid Tumors (RECIST), the therapeutic effect was divided into complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD). Investigators calculate the sum of the longest diameter of the target lesions from each patient by CT or MRI.
    Time Frame
    before and 8 week after treatment
    Secondary Outcome Measure Information:
    Title
    Observing the expression of lymphocyte subsets
    Description
    Patients were detected Lymphocyte subgroups of 2 ml peripheral blood by Flow cytometer (BD FACSCalibur), which inclunde the T cell subsets, NK cell subset, B cell subset(percentage)
    Time Frame
    before , the fourth and the seventh weeks of treatment
    Title
    Observing the expression of inflammatory factors
    Description
    2 ml of peripheral blood was taken from each patient. Flow cytometry was used to detect changes of inflammatory factor expression which include the IL-2, IL- 4, IL-5, IL-6, IL-9, IL-10, IL-13, IL-17A, IL-17F, IL-21, IL-22, IFN-γ and TNF-α(ug/ml)
    Time Frame
    before , the fourth and the seventh weeks of treatment
    Title
    Nutritional assessment
    Description
    Scored Patient-Generated Subjiective Global Assessment（PG-SGA）form was used in the present study. The total score of PG-SGA is summed by the following four subscale scores（A+B+C+D）. The first measurement score（A）is self-assessed by the subject and consists of the following four parts: Weight Table（0-4），Eating Situation Table（0-6），Symptom Table （0-22），Activity and Body Function Table（0-3）. The remaining three measurements are completed by trained registered clinical physicians， dieticians，and nurses: Scale of relationship between disease and nutritional needs（B）（0-6），Metabolic demand scale（C）（0-9），Physical examination scale（D）（0-24）. The scoring was controlled by one researcher (H.R). The lower scores represent a better outcome and the higher scores represent a worse outcome.
    Time Frame
    before , the fourth and the seventh weeks of treatment
    Other Pre-specified Outcome Measures:
    Title
    Multidimensional deficient power assessment
    Description
    Multidimensional deficient power assessment (MFSI-SF) was used in the present study. The MFSI-SF scale contains 30 subjects' subjective feelings，such as muscle soreness and memory loss. Subjects were scored according to the degree of each sensation (0-4). The MFSI-SF scale total score is the sum of each sensation score (0-120). The lower scores represent a better outcome and the higher scores represent a worse outcome.
    Time Frame
    before , the fourth and the seventh weeks of treatment
    Title
    Quality of life assessment
    Description
    Quality of Life Assessment Table (EORTC QLQ-C30) was used in the present study. The Quality of Life Assessment Table contains 28 subjects' subjective feelings and symptoms，such as tiredness and diarrhea within one week (A)，and two other indicators: health status，quality of life within one week (B). Subjects were scored according to the degree of each sensation (A 0-4) and (B 1-7). The Quality of Life Assessment Table is divided into two parts: the first part of the total score (0-112); the second part of the total scores (2-14). In the first part of the total scores: the lower scores represent a better outcome and the higher scores represent a worse outcome. In the second part of the total scores: the higher scores represent a better outcome and the lower scores represent a worse outcome.
    Time Frame
    before , the fourth and the seventh weeks of treatment
    Title
    Prognostic assessment
    Description
    The prognostic assessment by GPS scores which were calculated by detecting peripheral blood CRP and albumin from each tumor patients. GPS scores：CRP < 10 mg/l，albumin> 35g/l，GPS 0；CRP > 10 mg/l，albumin > 35 g/l，GPS 1；CRP > 10 mg/l，albumin < 35 g/l，GPS 2. The lower scores represent a better outcome and the higher scores represent a worse outcome.
    Time Frame
    before , the fourth and the seventh weeks of treatment
    Title
    Performance status assessment
    Description
    The performance status of patients with cancer is measured by the clinician through the ECOG score form (score:0-5)
    Time Frame
    before , the fourth and the seventh weeks of treatment
    Title
    Lean body mass
    Description
    Patient's waist circumference and weight were measured by trained registered clinical dietitians, and the measuring was controlled by one researcher (H.R). The researcher calculate lean body mass by measurements of waist circumference and body weight
    Time Frame
    before , the fourth and the seventh weeks of treatment
    Title
    Upper arm muscle circumference and upper arm muscle area
    Description
    Patient's upper arm circumference and triceps skinfold thickness were measured by trained registered clinical dietitians, and the measuring was controlled by one researcher (H.R). The researcher calculate Upper arm muscle circumference and upper arm muscle area by measurements of upper arm circumference and triceps skinfold thickness
    Time Frame
    before , the fourth and the seventh weeks of treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    yangwei w yang, master
    Phone
    13826524554
    Ext
    0755-82646002
    Email
    junweiyang@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    wenbin wb gao, doctor
    Phone
    13266778968
    Ext
    0755-82646002
    Email
    drwenbingao@163.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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