Comparison of the effect of hydroalcoholic extract of (Achillea Wihelmsii C.Koch) and routine treatment on chemotherapy-induced nausea and vomiting and quality of life in children aged 8-18 years with cancer
Determining the effect of Achillea Wilhelmsii C.Koch hydroalcoholic extract on chemotherapy-induced nausea and vomiting and quality of life in children aged 8-18 years with cancer
Design
This study is a double blinded clinical trial in which patients will be assigned to control and intervention groups using randomized block allocation and creating different number of blocks. The number of samples in this study is 40 people.
Settings and conduct
40 children aged 8-18 years with cancer referred to Seyed al-Shohda Hospital in Isfahan (Omid) who are eligible to enter the study will be selected through convenient sampling. And after obtaining informed consent, patients will be assigned to two control and intervention groups using random block allocation. The intervention group will receive capsules containing Achillea Wilhelmsii extract for one week, and the control group will receive placebo capsules. The study is a double-blind clinical trial. The drug prescriber and the patient themselves do not know the type of drug (placebo or plant extract).
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Children with cancer under chemotherapy that have nausea and vomiting
2. Having the informed consent of the children under study and legal guardian
3. Normal hematological and biochemical laboratory values of blood
Exclusion criteria:
1. Gastrointestinal diseases and cancers related to the gastrointestinal tract according to the discretion of the specialist physician
2. History of allergy to Achillea
Intervention groups
The intervention group is children with cancer undergoing chemotherapy who receive Achillea Wihelmsii C.Koch capsule intervention. The control group includes children with cancer undergoing chemotherapy who receive routine treatment intervention.
Main outcome variables
Nausea; Vomit; Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190120042436N4
Registration date:2022-07-09, 1401/04/18
Registration timing:prospective
Last update:2022-07-09, 1401/04/18
Update count:0
Registration date
2022-07-09, 1401/04/18
Registrant information
Name
Mohsen Salari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3323 4115
Email address
salarimo@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-22, 1401/04/31
Expected recruitment end date
2022-11-21, 1401/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of hydroalcoholic extract of (Achillea Wihelmsii C.Koch) and routine treatment on chemotherapy-induced nausea and vomiting and quality of life in children aged 8-18 years with cancer
Public title
The effect of Achillea Wihelmsii C.Koch on nausea and vomiting and quality of life
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-8 years
Having the informed consent of the children under study and legal guardian
Diagnosed with cancer
Having nausea and vomiting
Treated with chemotherapy drugs
Having at least one course of chemotherapy before the intervention
Normal hematological and biochemical laboratory values of blood
Exclusion criteria:
Gastrointestinal diseases and cancers related to the gastrointestinal tract at the discretion of a fellow physician
History of allergy to medicinal plants of the Achilleas family
Age
From 8 years old to 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The block method will be used to assign people to the studied groups. Random allocation by block method is for the purpose that exactly equal number of patients enter the intervention and control groups in consecutive time intervals. Groups are formed as A, B, C. To avoid the predictable risk of assigning people to different groups, blocks with different sizes will be created. Before assigning people to one of the groups, a list of letters (A, B, C), i.e. blocks with sizes 3, 9 and 12, is formed by the reliable website https://www.sealedenvelope.com.
Based on the order of coming to clinic, the children will be placed in one of the groups and this sampling will continue until the estimated sample size is reached in each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drug (Achillea Wihelmsii C.Koch extract) and placebo are prepared in capsules of the same color by a pharmacist and are coded by the pharmacist without the prescriber and the patient being aware of the type of drug (placebo or plant extract).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Yasuj University of Medical Sciences
Street address
shahid Jalil Street, Educational Pardis, Yasuj.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75919-94799
Approval date
2022-05-31, 1401/03/10
Ethics committee reference number
IR.YUMS.REC.1401.038
Health conditions studied
1
Description of health condition studied
nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
2
Description of health condition studied
cancer
ICD-10 code
C00-C97
ICD-10 code description
Malignant neoplasms
Primary outcomes
1
Description
nausea and vomiting
Timepoint
The number of nausea and vomiting episodes is recorded within 24 hours.
Method of measurement
Registration in Common Toxicity Criteria (CTC)
2
Description
Quality of Life
Timepoint
One week after chemotherapy
Method of measurement
Pediatric Quality of Life inventory4.0 Acute
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to receiving routine drugs to control nausea and vomiting caused by chemotherapy, the intervention group will receive two oral capsules containing 150 mg of Achillea wilhelmsii plant extract daily for one week. These capsules are made in the pharmacology department of medicinal plants of Yasouj University of Medical Sciences.
Category
Treatment - Drugs
2
Description
Control group: In addition to receiving routine drugs to control nausea and vomiting caused by chemotherapy, the control group will receive two placebo capsules daily for one week. Each placebo capsule contains 150 mg of starch. These capsules are made in the pharmacology department of medicinal plants of Yasouj University of Medical Sciences.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Seyed Al-Shohada Hospital
Full name of responsible person
Mohsen Salari
Street address
Isfahan, Motahhari Street
City
Esfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3235 0210
Fax
Email
omid@mui.ac.ir
Web page address
https://omid.mui.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr. Hossein Mari Oryad
Street address
Shahid Motahari Blvd., Vice Chancellor of Research, Yasuj University of Medical Sciences, Yasuj