A Phase 4 interventional study of Chemotherapy drugs and thalidomide and megestrol acetate in Cancer, Therapy-Related, sponsored by Shenzhen Fifth People's Hospital. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-19.
Sponsored by Shenzhen Fifth People's Hospital · Phase 4, Interventional, and Treatment
To observe the effect of thalidomide combined with megestrol acetate on lymphocyte, inflammatory factor regulation and nutritional status in patients with advanced malignant tumors.
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.
247 studies on the registry are indexed under Neoplasms, Second Primary; 48 are open to participants now.
This study's planned enrollment of 200 is above the median of 48 across 173 interventional studies indexed under Neoplasms, Second Primary.
Browse Neoplasms, Second Primary studies →This is the only study on the registry with Shenzhen Fifth People's Hospital as lead sponsor.
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Exclusion Criteria:
the patients were recepted chemotherapy alone
Drug: Chemotherapy drugs
the patients were recepted chemotherapy combined with thalidomide and megestrol
Drug: thalidomide and megestrol acetate
the patients were recepted the best supportive without chemotherapy
Other: optimal support treatment
the patients were recepted the best supportive combined with thalidomide and megestrol without chemotherapy
Drug: thalidomide and megestrol acetate
According to the NCCN Guidelines
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
Also known as: Chemotherapy drugs
Patients who cannot tolerate chemotherapy and other cancer treatments receive optimal support for 8 weeks
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
Also known as: optimal support treatment
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.
Time frame: before and 8 week after treatment
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)
Time frame: before , the fourth and the seventh weeks of treatment
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)
Time frame: before , the fourth and the seventh weeks of treatment
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.
Time frame: before , the fourth and the seventh weeks of treatment
Multidimensional deficient power assessment
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
Quality of life assessment
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
Prognostic assessment
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
Performance status assessment
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
Lean body mass
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
Upper arm muscle circumference and upper arm muscle area
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
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Plan to share: No
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