- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03777930
The Evaluation of Curative Effect on Treatment of Tumor Above Thalidomide Combined With Megestrol
December 12, 2018 updated by: Shenzhen Fifth People's Hospital
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
To observe the effect of thalidomide combined with megestrol acetate on lymphocyte, inflammatory factor regulation and nutritional status in patients with advanced malignant tumors.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: yangwei w yang, master
- Phone Number: 0755-82646002 13826524554
- Email: junweiyang@163.com
Study Contact Backup
- Name: wenbin wb gao, doctor
- Phone Number: 0755-82646002 13266778968
- Email: drwenbingao@163.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: chemotherapy group
the patients were recepted chemotherapy alone
|
According to the NCCN Guidelines
|
EXPERIMENTAL: chemotherapy combined with TH and MG group
the patients were recepted chemotherapy combined with thalidomide and megestrol
|
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 Names:
|
EXPERIMENTAL: the best supportive treatment group
the patients were recepted the best supportive without chemotherapy
|
Patients who cannot tolerate chemotherapy and other cancer treatments receive optimal support for 8 weeks
|
EXPERIMENTAL: the best supportive treatment combined with TH and MG group
the patients were recepted the best supportive combined with thalidomide and megestrol without chemotherapy
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Imaging efficacy evaluation
Time Frame: before and 8 week after treatment
|
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.
|
before and 8 week after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Observing the expression of lymphocyte subsets
Time Frame: before , the fourth and the seventh weeks of treatment
|
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)
|
before , the fourth and the seventh weeks of treatment
|
Observing the expression of inflammatory factors
Time Frame: before , the fourth and the seventh weeks of treatment
|
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)
|
before , the fourth and the seventh weeks of treatment
|
Nutritional assessment
Time Frame: before , the fourth and the seventh weeks of treatment
|
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.
|
before , the fourth and the seventh weeks of treatment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Multidimensional deficient power assessment
Time Frame: before , the fourth and the seventh weeks of treatment
|
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.
|
before , the fourth and the seventh weeks of treatment
|
Quality of life assessment
Time Frame: before , the fourth and the seventh weeks of treatment
|
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.
|
before , the fourth and the seventh weeks of treatment
|
Prognostic assessment
Time Frame: before , the fourth and the seventh weeks of treatment
|
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. |
before , the fourth and the seventh weeks of treatment
|
Performance status assessment
Time Frame: before , the fourth and the seventh weeks of treatment
|
The performance status of patients with cancer is measured by the clinician through the ECOG score form (score:0-5)
|
before , the fourth and the seventh weeks of treatment
|
Lean body mass
Time Frame: before , the fourth and the seventh weeks of treatment
|
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
|
before , the fourth and the seventh weeks of treatment
|
Upper arm muscle circumference and upper arm muscle area
Time Frame: before , the fourth and the seventh weeks of treatment
|
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
|
before , the fourth and the seventh weeks of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
December 10, 2018
Primary Completion (ANTICIPATED)
October 10, 2020
Study Completion (ANTICIPATED)
June 10, 2021
Study Registration Dates
First Submitted
August 25, 2018
First Submitted That Met QC Criteria
December 12, 2018
First Posted (ACTUAL)
December 19, 2018
Study Record Updates
Last Update Posted (ACTUAL)
December 19, 2018
Last Update Submitted That Met QC Criteria
December 12, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Neoplasms, Second Primary
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Hormonal
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Anti-Bacterial Agents
- Leprostatic Agents
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Synthetic
- Contraceptives, Oral, Hormonal
- Central Nervous System Stimulants
- Appetite Stimulants
- Thalidomide
- Megestrol
- Megestrol Acetate
Other Study ID Numbers
- shenzhenfifth 201807
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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