The effect of bromelain in preventing mucositis caused by 5-fluorouracil (FU5-) in patients with digestive system cancer.
Design
The present study is a trial-clinical research that examines the effect of bromelain in preventing mucositis caused by five-fluorouracil (FU5-) in 30 patients referred to Kowsar Hospital affiliated to Semnan University of Medical Sciences in 1403
Settings and conduct
The present study is a trial-clinical research that examines the effect of bromelain in preventing mucositis caused by five-fluorouracil (FU5-) in 30 patients referred to Kowsar Hospital affiliated to Semnan University of Medical Sciences in 1403.Bromelain will be used in the form of 500 mg tablets under the brand name "Anahil".
In this study, patients suffering from digestive system cancer will be included in the study and during their treatment period with FU5-, they will be in the control group in the first and second injection rounds and in the third and fourth rounds in the case group (use of bromelain tablets). Each patient will be examined 48 hours to one week after using this pill, and their degree of mucositis will be checked and recorded Bromelain is prescribed, and the second four sessions are with Bromelain, and then the side effects of oral mucositis are compared.
Participants/Inclusion and exclusion criteria
Patients with cancer of the digestive system who take fu5-bolus (within half an hour)
Intervention groups
Each patient will be examined 48 hours to one week after using this pill, and their degree of mucositis will be checked and recorded.
Main outcome variables
✓ The effect of Bromelain in preventing the severity of mucositis lesions according to the location of cancer (esophagus, stomach, colon)
✓ The effect of Bromelainin preventing the severity of mucositis lesions from 48 hours to one week after treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240601061970N1
Registration date:2024-06-21, 1403/04/01
Registration timing:registered_while_recruiting
Last update:2024-06-21, 1403/04/01
Update count:0
Registration date
2024-06-21, 1403/04/01
Registrant information
Name
anahid nabavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 731 1887
Email address
anahid.n78@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-07-22, 1403/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of bromelain in preventing mucositis caused by 5 fluorouracil (5-FU( in patients with gastrointestinal cancer
Public title
Investigating the effect of bromelain in preventing mucositis caused by 5 fluorouracil (5-FU( in patients with gastrointestinal cancer
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with cancer of the digestive system who take fu5-bolus (within half an hour)take
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
4
Each person is studied 4 times. 2 times without medicine and 2 times with medicine.
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of semnan university of medical sciences
Street address
Eram 3 blv
City
Semnan
Province
Semnan
Postal code
3519673963
Approval date
2024-01-29, 1402/11/09
Ethics committee reference number
IR.SEMUMS.REC.1402.274
Health conditions studied
1
Description of health condition studied
patients with gastrointestinal cancer
ICD-10 code
C26.9
ICD-10 code description
Malignant neoplasm of ill-defined sites within the digestive system
Primary outcomes
1
Description
effect of bromelain in preventing mucositis caused by five fluorouracil (5-FU) in patients with gastrointestinal cancer
Timepoint
In this study, patients with digestive system cancer will be included in the study and in their treatment period with 5-FU, they will be in the control group in the first and second injection rounds and in the third and fourth rounds in the case group (use of bromelain tablets). took Each patient will be examined 48 hours to one week after using this pill, and their degree of mucositis will be checked and recorded. Due to the fact that in colorectal cancers, 12 sessions of 5 fu chemotherapy drugs are injected, the first four sessions are without bromelain administration and the second four sessions are with bromelain, and then the side effects of oral mucositis are compared.
Method of measurement
Oral mucositis will be graded based on the World Health Organization index, and the severity of mucositis will be recorded in a special form for each patient.
Secondary outcomes
empty
Intervention groups
1
Description
Control group: The first and second session of each patient . In this study, patients with digestive system cancer will be included in the study and in their treatment period with 5-FU, they will be in the control group in the first and second injection rounds and in the third and fourth rounds in the case group (use of bromelain tablets). Each patient will be examined 48 hours to one week after using this pill, and their degree of mucositis will be checked and recorded. Due to the fact that in colorectal cancers, 12 sessions of 5 fu chemotherapy drugs are injected, the first four sessions are without bromelain administration and the second four sessions are with bromelain, and then the side effects of oral mucositis are compared. Bromelain will be used in the form of 500 mg tablets under the brand name "Anahil".
Category
Treatment - Drugs
2
Description
Intervention group: The third and fourth session of each patient
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Hospital affiliated to Semnan University of Medical Sciences
Full name of responsible person
Dr Farahnaz Ghahremanfard
Street address
Eram 3 - 15
City
Semnan
Province
Semnan
Postal code
3519673963
Phone
+98 912 731 1887
Email
anahid.n78@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Farahnaz Ghahremanfard
Street address
Eram 3 .
City
Semnan
Province
Semnan
Postal code
3519673963
Phone
+98 912 731 1887
Email
anahid.n78@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Dr Farahnaz Ghahremanfard
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology and oncology
Street address
Eram 3
City
Semnan
Province
Semnan
Postal code
3519673963
Phone
+98 912 731 1887
Email
anahid.n78@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Farahnaz Ghahremanfard
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Others
Street address
Eram 3
City
Semnan
Province
Semnan
Postal code
3519673963
Phone
+98 912 731 1887
Email
anahid.n78@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Farahnaz Ghahremanfard
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Others
Street address
Eram 3
City
Semnan
Province
Semnan
Postal code
3519673963
Phone
+98 912 731 1887
Email
anahid.n78@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available