Determine the effect of quince paste on nausea, vomiting and appetite in children with lymphoma under chemotherapy
Design
A randomized, parallel, controlled clinical trial. A total of 80 eligible participants will be divided using simple randomization into one of two groups - intervention and control (n=40).
Settings and conduct
This study will be conducted in the oncology department of Shahid Sadoughi Hospital in Yazd. A total of 80 eligible individuals will be randomly assigned to 2 groups for 3 days. Information on body composition, medical history, and demographic data will be recorded at the start of the study. The weight of individuals before and after the intervention will be recorded. The number of vomiting episodes per day for each person will be recorded. The level of nausea will be assessed using the Baxer animated retching faces tool. To assess appetite, hunger, and satiety, the Visual Analog Scale (VAS) tool will be used.
Participants/Inclusion and exclusion criteria
Individuals with malignant cancer aged 5 to 18 years, who have been hospitalized for at least three days for chemotherapy treatment and have a maximum score of 2 for daily activity. Exclusion criteria: being on enteral or parenteral nutrition, a history of quince allergy or symptoms after consumption, abdominal or pelvic radiotherapy one week before starting, vomiting within 24 hours before chemotherapy, pregnancy, and breastfeeding.
Intervention groups
Intervention group: Individuals will receive their regular medication regimen along with children receiving a tablespoon of quince paste before each meal and a tablespoon after each meal for 3 days. Control group: These individuals will only receive the usual medication regimen.
Main outcome variables
Number of vomiting episodes; level of nausea; level of appetite
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240514061792N1
Registration date:2024-07-14, 1403/04/24
Registration timing:prospective
Last update:2024-07-14, 1403/04/24
Update count:0
Registration date
2024-07-14, 1403/04/24
Registrant information
Name
Rouhollah Edalatkhah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3822 4000
Email address
drr.edalatkhah@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2025-03-19, 1403/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of quince paste on nausea, vomiting, and appetite in children with lymphoma under chemotherapy
Public title
Investigating the effect of quince paste on the treatment of anorexia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 5 to 18 years
Definitive diagnosis of lymphoma
Hospitalization for at least 3 days for chemotherapy
Maximum daily activity score (ECOG) 2
Exclusion criteria:
Being under enteral or parenteral nutrition (partially or completely)
History of allergy to quince and occurrence of allergic symptoms related to after consumption
Abdominal or pelvic radiation therapy one week before the start of the study
Occurrence of vomiting 24 hours before the start of chemotherapy
Age
From 5 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization based on gender (male and female) and BMI percentile for age, as randomization stratified randomization with a block size equal to 8 and 2 times will be repeated. The group assigned to the people will be placed in sealed envelopes in advance and then when the participant visits and after the approval of the eligible The condition of entering the study is that the envelope will be opened and will be placed in the designated 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
Ethics committee of Shahid Sadoughi University of Medical Sciences Yazd
Street address
Blood and Cancer Research Center for Children, Yazd, Shahid Sadoughi Teaching Hospital, Yazd
City
Yazd
Province
Yazd
Postal code
8917693571
Approval date
2022-01-12, 1400/10/22
Ethics committee reference number
IR.SSU.MEDICINE.REC.1400.375
Health conditions studied
1
Description of health condition studied
Nausea and vomiting in lymphoma
ICD-10 code
C91
ICD-10 code description
Lymphoid leukemia
Primary outcomes
1
Description
Level of nausea
Timepoint
6 times a day after the start of the intervention
Method of measurement
Baxer animated retching faces
2
Description
Appetite level
Timepoint
6 times a day after the start of the intervention
Method of measurement
Visual analog scale (VAS)
3
Description
Hunger level
Timepoint
Daily after starting intervention
Method of measurement
Visual analog scale
4
Description
Level of fullness
Timepoint
Daily after starting intervention
Method of measurement
Visual analog scale
5
Description
vomiting episodes
Timepoint
Daily after starting intervention
Method of measurement
Criteria for Adverse Events (CTCAE)
Secondary outcomes
1
Description
Height
Timepoint
Before the intervention, 3 days after the intervention
Method of measurement
Tape measure
2
Description
Weight
Timepoint
Before the intervention, 3 days after the intervention
Method of measurement
Weighting scale
3
Description
Body Mass Index (BMI)
Timepoint
Before the intervention, 3 days after the intervention
Method of measurement
Formula
Intervention groups
1
Description
Intervention group: The study subjects are children aged 5 to 18 with malignancy who will be hospitalized for a minimum of 3 days at Shahid Sadoughi Hospital in Yazd to undergo chemotherapy. In addition to routine drug treatments, these individuals will be given a tablespoon of jam before each meal and another tablespoon after each meal for 3 days to help reduce daily nausea and vomiting. The number of vomiting episodes per day will be recorded for each individual and scored based on the CTCAE V 4.03 criteria. Nausea will be assessed using the Baxer animated retching faces tool. The Visual Analog Scale (VAS) will be used to measure appetite, hunger, and satiety levels. Nausea and appetite levels will be assessed 6 times a day (before and after each meal). Also, the height and weight of children will be measured before and after the start of the intervention
Category
N/A
2
Description
Control group: Children aged 5 to 18 with malignancies who will be hospitalized for at least 3 days at Shahid Sadoughi Hospital in Yazd for chemotherapy. Individuals in this group will only follow their regular medication regimen. The number of vomiting episodes per day per person will be recorded and scored based on the CTCAE V 4.03 criteria. The level of nausea will be assessed using the Baxer animated retching faces tool. To assess appetite, hunger, and satiety, the Visual analog scale (VAS) tool will be used. Nausea and appetite will be measured 6 times a day (before and after each meal). Additionally, the height and weight of children will be measured before and after the start of the intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Blood and Oncology, Shahid Sadoughi Hospital, Yazd
Full name of responsible person
Rouhollah Edalatkhah
Street address
Blood and Cancer Research Center for Children, Yazd, Shahid Sadoughi Teaching Hospital, Yazd
City
Yazd
Province
Yazd
Postal code
8917693571
Phone
+98 35 3822 4000
Email
drr.edalatkhah@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amin Salehi Abargouei
Street address
Vice President of Research and Technology of Shahid Sadoughi University of Medical Sciences, Imam Reza Research Educational Complex, Student Blvd, Imam Hossein Square, Yazd City
City
Yazd
Province
Yazd
Postal code
891618863
Phone
+98 35 3623 8506
Email
dvc.research@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Vida Shamsaddini Nargani
Position
Master student in nutrition science
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, Faculty of Health, Shahid Sadoughi University of Medical Sciences, Alam Square, Yazd City
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3149 2228
Email
vidashams2000@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Rouhollah Edalatkhah
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
National Blood and Cancer Research Center, Yazd, Yazd Shahid Sadoughi Hospital
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3822 4000
Email
drr.edalatkhah@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Vida Shamsaddini Nargani
Position
Master Student in nutrition science
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, Faculty of Health, Shahid Sadoughi University of Medical Sciences, Alam Square, Yazd City
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3149 2228
Email
vidashams2000@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
primary outcome will be available at the end of study
When the data will become available and for how long
From January 2024
To whom data/document is available
Academic institutions
Under which criteria data/document could be used
Academic institutes can send their official request to the email of the scientific director of the project. the data will be sent after confirmation of ethics committee of shahid sadoughi university of medical sciences. It is not possible to perform statistical analysis on the data
From where data/document is obtainable
Ruhollah Adalatkhah, Assistant Professor, Shahid Sadoughi University of Medical Sciences, Yazd, Email: drr.edalatkhah@gmail.com, Phone: 035-38224000
What processes are involved for a request to access data/document
Academic institutes can send their official request to the email of the scientific director of the project. The data will be sent after confirmation of ethics committee of Shahid Sadoughi university of medical sciences