The purpose of this study was to evaluate the efficacy of Plantago syrup on the prevention of pulmonary radiotherapy in patients with breast cancer.
Design
Sixty patients with breast cancer participated in this study, who were randomly divided into two groups of intervention (n = 30) and control (n = 30). The intervention group received the syrup and the control group received the placebo.
Settings and conduct
This study is a double blind randomized clinical trial (participant and analyzer) in which a population of women with breast cancer is studied.
The study is being conducted at Khansari Hospital in Arak.
Participants are given Plantago syrups and placebo for three month.
After three months spirometric parameters such as 1 FEV and FVC and 1 FVC / FEV ratio are measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Breast Cancer and Candidate Radiation Therapy
2. Ages between 17 and 65 years
3. Life expectancy of more than one year based on estimates of physician or medical team
4. Physical and mental ability to cooperate in filling out the questionnaire
5. Willingness to participate in the study
6. Absence of neutropenia, immune system weakness, myelosuction.
Exclusion criteria:
1.Alcohol use, taking lung-affecting drugs such as antidepressants and opioids
2.History of connective tissue diseases such as Sjogren's, rheumatoid arthritis, diabetes;
3. History of dehydration-causing diseases such as chronic diarrhea, immunosuppressive diseases, myelosuppression
Intervention groups
Intervention group: Patients with breast cancer who are candidates for radiotherapy receiving syrup
Control group: Patients with breast cancer are candidates for radiotherapy receiving placebo
Main outcome variables
Forced Vital Capacity ؛Forced Expiratory Volume in First Second ؛ Forced Vital Capacity (FVC) Ratio to Forced Expiratory Volume in First Second (FEV1)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180617040114N2
Registration date:2019-11-09, 1398/08/18
Registration timing:registered_while_recruiting
Last update:2019-11-09, 1398/08/18
Update count:0
Registration date
2019-11-09, 1398/08/18
Registrant information
Name
jamal Amri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3502
Email address
jamal.amri71@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-11, 1398/07/19
Expected recruitment end date
2020-01-09, 1398/10/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Plantago on the prevention of pulmonary complications of radiation therapy in patients with breast cancer
Public title
Effect of Plantago on the of pulmonary complications of radiation therapy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Breast Cancer and Candidate Radiation Therapy
Ages between 17 and 65 years
Life expectancy of more than one year based on estimates of physician or medical team
Physical and mental ability to cooperate in filling out the questionnaire
Exclusion criteria:
People with liver and kidney disease.
People who have a history of allergy to herbal medicines.
Age
From 17 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization method with 4, 6 and 8 block sizes will be used to assign people to the two groups. Concealment will also be observed by using this method. In this way, each individual is assigned a unique code and is attached to drug packages that will help the blind process.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the patient and the analyzer are blinded. Patients are not aware of the contents of the syrup glass and are similar in appearance to the syrup glass. And the analyzer is not aware of the data obtained.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Next to Amir al-Momenin Hospital,Bsij Square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2019-07-23, 1398/05/01
Ethics committee reference number
IR.ARAKMU.REC.1398.078
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Forced Vital Capacity (FVC)
Timepoint
Before intervention and three months after intervention
Method of measurement
Spirometry
2
Description
Forced Expiratory Volume in the second period (FEV1)
Timepoint
Before intervention and three months after intervention
Method of measurement
Spirometry
3
Description
Forced Vital Capacity (FVC) Ratio to Forced Expiratory Volume in the second period (FEV1)
Timepoint
Before intervention and three months after intervention
Method of measurement
Spirometry
Secondary outcomes
1
Description
Phlegm and mucus in the throat
Timepoint
Before intervention and three months after intervention
Method of measurement
Aspiration
2
Description
Score of quality life
Timepoint
Before intervention and three months after intervention
Method of measurement
Quality of Life Questionnaire
Intervention groups
1
Description
Intervention group: This group includes 30 patients with breast cancer who are candidates for radiotherapy. This group receives the Plantago syrup for three months with treatment
Category
Prevention
2
Description
Control group: This group includes 30 patients with breast cancer who are candidates for radiotherapy. This group received placebo for three months with treatment
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah khansari hospital
Full name of responsible person
Seyed Amir Hossein Latifi
Street address
Daneshgah Street, Arak
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3313 6055
Fax
Email
TCMR.2016@GMAIL.COM
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Next to Amir al-Momenin Hospital, Basij Square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3645
Email
TCMR.2016@GMAIL.COM
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor for research, Arak 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
Arak University of Medical Sciences
Full name of responsible person
Seyed Amir Hossein Latifi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Next to Amir al-Momenin Hospital, Basij Square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 38 4817 6341
Email
seiedalatifi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Seyed Amir Hossein Latifi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Next to Amir al-Momenin Hospital, Basij Square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3645
Email
seiedalatifi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Seyed Amir Hossein Latifi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Next to Amir al-Momenin Hospital, Basij Square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3645
Email
seiedalatifi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD