The aim of this study is determination of the effect of viola tablet on cancer fatigue in breast cancer patients.
Design
In this pilot study, which is performed in a simple, double-blind and randomized way using placebo, a maximum of 20 (10 people in each group) volunteer patients with breast cancer in the age range of 18-70 years who complain of fatigue, based on Inclusion criteria will be included in the study.
Settings and conduct
Before the intervention, a data collection form is completed for all patients referred to the radiotherapy-oncology section of Shohada-e-Tajrish Hospital. Fatigue severity is measured according to the criteria of visual analog fatigue scale, fatigue severity scale and cancer fatigue scale. Patients are devided to two groups randomly. Viola and placebo tablets will be packaged and coded in the same way. Patients' fatigue is measured at the beginning and end of the intervention (weeks of 0 and 4).
Participants/Inclusion and exclusion criteria
Women aged 18 to 70 years old
Suffering from breast cancer
During radiotherapy
Hemoglobin at least 8 g /dl
Hematocrit at least 30%
SGOT level less than 3 times the upper limit of normal
Bilirubin less than 2mg /dl
Creatinine less than 2mg /dl
normal TSH
Intervention groups
Intervention group: Group receiving viola tablets
Control group: Placebo
Main outcome variables
Visual Analogue Fatigue Scale;Fatigue Severity Scale;The Cancer Fatigue Scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220302054170N1
Registration date:2022-03-13, 1400/12/22
Registration timing:prospective
Last update:2022-03-13, 1400/12/22
Update count:0
Registration date
2022-03-13, 1400/12/22
Registrant information
Name
Homa Hajimehdipoor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 6168
Email address
hajimehd@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2023-04-21, 1402/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
investigating the effect of Viola odorata L. tablet on breast cancer-related fatigue: Pilot study
Public title
investigating the effect of Viola tablet on breast cancer-related fatigue
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 18 to 70 years old
Suffering from breast cancer
During radiotherapy
Hemoglobin at least 8 g / dl
Hematocrit at least 30%
SGOT level less than 3 times the upper limit of normal
Bilirubin less than 2mg / dl
Creatinine less than 2mg / dl
normal TSH
Exclusion criteria:
Heart disease with unstable conditions
Debilitating lung disease
History of asthma
History of allergies to Viola or any of the excipients in tablets
Uncontrolled pain
Severe infection
Serious accompanying disease
Age
From 18 years old to 70 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
A table of random numbers will be created by rand Excel software. Before starting, we will determined the direction of selecting random numbers (for example from top to bottom). A series of random numbers will be selected from the table, and even numbers will be assigned to the control group and odd numbers to the intervention group. The codes will be then written on drug labels and kept secretly in an envelope. Containers containing coded drugs and placebo will be provided to the physician and research assistant. Patients start receiving from the smallest number of container to enter the plan. The first patient will be entered into the research will receive the intervention related to smallest code, and the last patient will receive the biggest code.
Randomization unit: individual
Randomization tool: Random number table
Blinding (investigator's opinion)
Double blinded
Blinding description
The tablets code will be written to the file. The physician, assistant, and patient will not be aware of any tablet content. (double-blind).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-Chancellor in Research Affairs - Shahid Beheshti University of Medical Sciences
The aqueous extract is prepared by boiling for 10 minutes using water in a ratio of 1:10. The extract prepared in the oven is dried at a temperature of 100 degrees and the resulting powder is used in the tablet formulation. To prepare the tablet, various types of medicinal excipients are used and pre-formulation studies are performed on them. The number of tablets used by patients after the tablet formulation will be determined depending on the amount of extract in each tablet. Since the effective dose in the animal study was 100 mg / kg and considering the formula: Equivalent human dose (mg / kg) = animal dose (mg / kg) × 0.162, the amount of extract for each person 60 kg was 972 mg. Per day is a dry extract of violet. Depending on the final formulation, there will be either two tablets per day (each containing 486 mg of extract) or three tablets per day (each containing 324 mg of extract).
Category
Treatment - Drugs
2
Description
Control group: The placebo will be made to look exactly like the original drug using the tablet's excipients.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Radiotherapy Center - Oncology of Shohada Tajrish Hospital
Full name of responsible person
Ghazale Heydari rad
Street address
Department of Radiotherapy, Shohadaye Tajrish Hospital , Tajrish Square,Tehran
City
Tehran
Province
Tehran
Postal code
19899 34148
Phone
+98 21 2271 8081
Email
ghazalrad@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Homa Hajimehdipoor
Street address
No.8, shams Ali, Valiasr Ave.
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
Hajimehd@sbmu.ac.ir
Grant name
Research Assistant of Shahid Beheshti University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Homa Hajimehdipoor
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No.8, shams Ali, Valiasr Ave.
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 6168
Fax
Email
hajimehd@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Homa Hajimehdipoor
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No.8, shams Ali, Valiasr Ave.
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 6168
Fax
Email
hajimehd@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Homa Hajimehdipoor
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No.8, shams Ali, Valiasr Ave.
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 6168
Fax
Email
hajimehd@sbmu.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
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