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Comparison of the effectiveness of Galenos Barij Syrup on preventing nausea and vomiting in patients referred to outpatient chemotherapy receiving the regime with high emetic chemotherapy (HEC) compared to the standard regime

Protocol summary

Study aim
Evaluating the effectiveness of Galenos barrage syrup with standard treatments to prevent chemotherapy‐induced nausea and vomiting (CINV) in patients receiving highly emetogenic chemotherapy (HEC) based on Rhodes Index and NRS score Identification of different side effects of Galenos barrage syrup in patients treated with highly emetogenic chemotherapy (HEC) regimens
Design
This is a multicenter, controlled, parallel-group, unblended, randomized, phase III, and clinical trial on 56 patients. Block randomization was used to reduce bias in trial.
Settings and conduct
Patients admitted to the Tooba clinic and Imam Khomeini Hospital in Sari were included based on inclusion and exclusion criteria and randomly assigned to two separate (intervention and control) groups. The intervention group will receive the combination of standard antiemetic therapy plus chemotherapy and control group will receive standard antiemetic therapy (aprepitant, granisetron, and dexamethasone).
Participants/Inclusion and exclusion criteria
Inclusion criteria Patients ≥ 18 years old receiving high emetogenic chemotherapeutic agents Exclusion criteria Patients who have known allergy or severe side effect on Ginger consuming Ginger within a week before the intervention receiving warfarin, heparin, and aspirin Patients with a history of a neurological disorder, seizures and epilepsy, hematologic diseases Patients with GI obstruction, brain and/or GI metastasis Patients who lack capacity to consent to research
Intervention groups
Intervention: In addition to standard antiemetic therapy, patients received Galenos barrage syrup 5-10 CC according to body weight before each meal on the same day as the chemotherapy regimen Control: Standard antiemetic therapy (aprepitant, granisetron, and dexamethasone)
Main outcome variables
Nausea and vomiting based on Rhodes Index and NRS score and side effects of Galenos barrage syrup

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230807059069N1
Registration date: 2023-10-24, 1402/08/02
Registration timing: registered_while_recruiting

Last update: 2023-10-24, 1402/08/02
Update count: 0
Registration date
2023-10-24, 1402/08/02
Registrant information
Name
Mohammad Mehdi Vaziri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 1700
Email address
drmmvaziri@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of Galenos Barij Syrup on preventing nausea and vomiting in patients referred to outpatient chemotherapy receiving the regime with high emetic chemotherapy (HEC) compared to the standard regime
Public title
The effect of Galenos Barij Syrup on nausea and vomiting caused by chemotherapy with strong emetic ability compared to standard treatment.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
People over the age of 18 Patients under high emetogenic chemotherapy regimens (HEC) referring to outpatient chemotherapy at Imam Khomeini Hospital and Baghban Complex
Exclusion criteria:
Allergy to ginger Ginger consumption within a week before the start of the intervention Users of warfarin, heparin and aspirin drugs History of neurological diseases, history of seizures and epilepsy, history of blood disorders Patients with bowel obstruction or brain or bowel metastasis Lack of consent to participate in the study
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 56
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation will be done by block method (Randomization Block) with a block size of four and using Sealed Envelope online software at the address https://www.sealedenvelope.com at an individual level and by an epidemiologist researcher who is a member of the research team. In this site, which is an online software for creating random allocation, the create list option is selected through the randomization menu, and then the required parameters such as groups A and B, the number of blocks, which is 4, and the total number of samples will be entered. And finally the random allocation list will be created. A sealed non-transparent envelope will be used for concealment. Researchers enroll eligible participants after the baseline assessment, then remove and open each envelope in the order that corresponds to the participant's initial assessment order, and assign the eligible participant to either the intervention group or the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Imam (RA) Sari Educational and Medical Hospital - Mazandaran University of Medical Sciences (Researc
Street address
Imam Khomeini Hospital, Razi St.
City
Sari
Province
Mazandaran
Postal code
4816633131
Approval date
2022-07-10, 1401/04/19
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1402.044

Health conditions studied

1

Description of health condition studied
Chemotherapy
ICD-10 code
Z51.1
ICD-10 code description
Encounter for Antineoplastic Chemotherapy and Immunotherapy

Primary outcomes

1

Description
The Rhodes Index questionnaire will evaluate the main outcome of the study. This tool (Nausea and Vomiting Index) is designed as a 5-point Likert scale (score 0-4). The final score range will vary between 0-32. In order to interpret the scores obtained from the questionnaire, the average scores related to nausea and vomiting in each group were calculated. The Rhodes questionnaire will be completed daily.All patients were provided with a daily side effect checklist at the first visit to the outpatient chemotherapy clinic. Using the checklist, patients will record daily their nausea with a numerical rating scale (NRS) (0-10) and the number of times or episodes of vomiting up to 7 days after chemotherapy. The physician implementing the plan will record the amount of control of nausea and vomiting in the medical record after confirming the data or hearing the results of the patients at the next visit. Complete protection from nausea (NRS <1) and vomiting (no episodes) during the acute (within 24 hours after chemotherapy) and delayed (within 2 to 7 days after chemotherapy) episodes in patients receiving the first cycle of chemotherapy or will be evaluated in general cycles of chemotherapy.
Timepoint
Patients will record daily nausea (0-10) and the number of times or episodes of vomiting up to 7 days after chemotherapy.
Method of measurement
Rhodes Index Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In our current study, we used 5-10 cc barrage syrup based on person weight. Barrage syrup is containing fruit (Cydonia oblonga), ginger (Zingiberofficinale), vinegar and honey as an adjunctive treatment to the standard treatment containing a 5-HT3R inhibitor (Granicitron (Kytril brand)), NK1 receptor antagonist ( We will use aperpitant (amand brand name) and dexamethasone.The anti-nausea effect of this product is on the one hand due to the presence of "Bah" fruit extract and on the other hand due to the presence of ginger. It becomes natural. Also, consuming "beh" after meals helps to eliminate indigestion and improve the digestive condition.Natural honey has antimicrobial and antibacterial properties and other enzymes that produce a small amount of hydrogen peroxide. Hydrogen peroxide, in turn, relieves you of indigestion. Natural honey contains the enzymes invertase, catalase, peroxidase, glucose oxidase, phosphatase and enolase acid, which help in proper digestion. It also contains potassium, which relieves nausea and inflammation of the lining of the esophagus and helps the stomach to neutralize acids. Honey is anti-nausea, and regular consumption of honey affects the muscles of the stomach and helps with proper digestion. . Also, natural honey stabilizes the content of hydrochloric acid in the body.Being rich in some vitamins, vinegar is very effective in the health of the digestive system and its elimination of toxins. It also has a significant effect in the treatment of some diseases and disorders of the digestive system, such as better digestion of food and reduction of nausea.
Category
Treatment - Drugs

2

Description
Control group: According to the clinical guidelines for the prevention of CINV in people undergoing chemotherapy with a high risk of emesis (HEC), a combination of 5-HT3 receptor antagonist (Granicitron 3 mg), NK-1 receptor antagonist (Aprepitant 125 mg daily) and dexamethasone 8 mg will be used as the standard before chemotherapy and a combination of aprepitant and dexamethasone will be given on days 2 and 3 and dexamethasone on day 4.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Mohammad Mehdi Vaziri
Street address
Razi St
City
Sari
Province
Mazandaran
Postal code
4818834935
Phone
+98 11 3336 1700
Email
drmmvaziri@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Vice President of Research and Technology(Dr. Pedram Ebrahimnejad)
Street address
Taleghani Boulevard, Moalem Street, Moalem Square
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3448 4805
Email
Pebrahimnejad@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Vaziri
Position
Oncology specialist assistant
Latest degree
Specialist
Other areas of specialty/work
Hematology
Street address
Razi Ave.
City
Sari
Province
Mazandaran
Postal code
48816633131
Phone
+98 11 3336 4044
Email
drmmvaziri@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Vaziri
Position
Fellowship
Latest degree
Specialist
Other areas of specialty/work
Hematology
Street address
Razi
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 4044
Fax
Email
drmmvaziri@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Vaziri
Position
Fellowship
Latest degree
Specialist
Other areas of specialty/work
Hematology
Street address
Razi
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 4044
Fax
Email
drmmvaziri@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Only a part of the data, such as the information related to the main result or the like, can be shared.
When the data will become available and for how long
Since 2025
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
There are no other conditions for the use of data or documentation. No analysis is allowed on the delivered data.
From where data/document is obtainable
MOHAMMAD MEHDI VAZIRI drmmvaziri@gmail.com
What processes are involved for a request to access data/document
After communicating through the above email, the desired request will be submitted
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