Evaluation of the effect of ACA1 product on quality of life, hematological and biochemical indicators of patients with gastric adenocarcinoma
Design
Two arm parallel group randomized clinical trial, double-blind, with 20 patients
Settings and conduct
This study is a double-blind clinical trial conducted as a pilot at Ayatollah Taleghani Hospital in Tehran. 20 patients after completing the standard questionnaire of quality of life of cancer patients EORTC-QLQ-30 and performing liver tests (PT-PTT-INR-ALP-AST-ALT) and kidney (urea -Cr) and complete counting of CBC blood cells entered the study and randomly divided into two groups of ten interventions and control and as a double-blind, intervention treatment group with ACA1 product at a dose of 2100 mg per day (three capsules). 670 mg, which is given three times a day for half an hour after a meal, is given for 1 month. The control group will also be treated daily with three placebo capsules according to the same instructions. Medication and placebo do not differ in weight, shape, color, odor, or taste. After 1 month, the standard EORTC-QLQ-30 questionnaire will be completed by patients. Patient Lab tests will be reviewed.
Participants/Inclusion and exclusion criteria
Admission: Patients with metastatic gastric adenocarcinoma
Lack of entry conditions: Positive serology for HIV, HBV, HCV, CNS metastasis, other malignancies
Intervention groups
Intervention group: treated with ACA1 product at a dose of 2100 mg per day for 1 month
Control group: daily treatment with placebo capsules three times a day for 1 month
Main outcome variables
Improving the quality of life; Improving laboratory tests
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200626047927N1
Registration date:2020-07-11, 1399/04/21
Registration timing:prospective
Last update:2020-07-11, 1399/04/21
Update count:0
Registration date
2020-07-11, 1399/04/21
Registrant information
Name
Zahra Sharifan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2257 2759
Email address
z.sharifan@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2021-07-22, 1400/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of ACA1 on the Quality of Life in Patients with Gastric adenocarcinoma: a pilot study
Public title
Evaluation of the Effect of ACA1 on Gastric adenocarcinoma:
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with gastric adenocarcinoma whose disease has been confirmed histologically, are in the metastatic stage and at least two common chemotherapy treatments have been administered to them and the disease is not under control.
Adequate bone marrow function: 4000<WBC<12000, Neutrophyl>1500, Plt>100000, Hb>8
Adequate liver function: Total Bill>1.5, AST&ALT<100
Adequate kidney function: Cr<1.5
performance status≤1
Exclusion criteria:
positive serology for HIV, HBV, HCV
Metastasis to CNS
other malignancies
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
The method of allocating samples in this study is stratified randomization. Initially, patients eligible for study based on gender and initial performance (according to the ECOG table) were divided into four groups (first group: male, 0 performance), (second group: male, 1 performance), (third group: female, 0 performance), (Group 4: female, 1 Performance ) are divided. Patients in each group are then assigned to two groups of drugs and placebo based on a table of random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
A pharmacist at Shahed University Research Center prepares and codes the drug and placebo in such a way that they do not differ in weight, shape, color, odor or taste. He packs medicine and placebo in packs and gives them to the researcher. This person will not provide researchers with information about the samples until after the data analysis. All participants in this project and the clinical caregiver of the drug provider to the participants and the physician (the main researcher of the project) who is also responsible for data collection are unaware of the type of drug.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee on Biomedical Research of Shahed University
Street address
Shahed University, Persian Gulf Highway (Tehran - Qom), Tehran
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2020-06-15, 1399/03/26
Ethics committee reference number
IR.SHAHED.REC.1399.039
Health conditions studied
1
Description of health condition studied
Gastric adenocarcinoma
ICD-10 code
C16
ICD-10 code description
Malignant neoplasm of stomach
Primary outcomes
1
Description
Quality of Life
Timepoint
Start of study (before the start of the intervention) and one month after the start of ACA1 consumption
Method of measurement
EORTC-QLQ-30 Standard questionnaire
Secondary outcomes
1
Description
White Blood Cell Count
Timepoint
Start studying (before starting the intervention) and one month after starting ACA1 consumption
Method of measurement
Cell Counter
2
Description
Hemoglobin
Timepoint
Start studying (before starting the intervention) and one month after starting ACA1 consumption
Method of measurement
Cell Counter
3
Description
Platelet Count
Timepoint
Start studying (before starting the intervention) and one month after starting ACA1 consumption
Method of measurement
Cell Counter
4
Description
Body Mass Index
Timepoint
Start studying (before starting the intervention) and one month after starting ACA1 consumption
Method of measurement
Meter and scale
Intervention groups
1
Description
Intervention group: This group was treated with ACA1 capsules for 2100 mg per day for one month.
Category
Treatment - Drugs
2
Description
Control group: This group is treated with placebo capsules three times a day for a month