Protocol summary

Summary
The study was aimed to evaluate the effects of honey and cinnamon solution for the quality of life of patients with breast cancer. Inclusion criteria: patients with ages ranging from 20-60; with expectancy over 6 months; and their willingness to cooperate in the study. Exclusion criteria: allergic reactions to the drugs; psychopathic patients; chemotherapy or advised for chemotherapy in the next week. The overall quality of life and its sub categories were assessed during two phases; one week before and after receiving the solution the EORTC QLQ-C30 questionnaire were recorded. Patients were advised to mix one full spoon of honey with one teaspoon full cinnamon in boiling water and to be taking it 3 times a day for one week. During the study patients did not receive any anti-cancer intervention. Findings of this study were collected on the effects of honey and cinnamon on reducing limitations in long walking, power walking, daily rest needs, aid in personal care, limitation in undertaking daily routines and hobbies, Pain, No needs for rest, sleeping disorders, feeling weakness ,lack of appetite, constipation , tiredness, effects of pain in undertaking daily chores , feeling stressed , feeling worried, feeling irritable, depression and the overall improvement of life before and after using the solution. And then both of the questionnaires were compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201409081772N16
Registration date: 2014-09-29, 1393/07/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-09-29, 1393/07/07
Registrant information
Name
Dawood Aghamohammadi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1381 8940
Email address
aghamohammadid@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research, Tabriz University of Medical Sciences
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2014-06-22, 1393/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of Honey and Cinnamon mixture consumption for improving quality of life in breast cancer patients
Public title
Effect of Honey and Cinnamon mixture on improving patient's quality of life
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria: patients in rang of 20-60 Y/O; life expectancy more than 6 month; willingness to participation in the study
Age
From 20 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz university of medical science , reseach ethical committee
Street address
Daneshghah street/ Tabriz university of medical science/ Vice chancellor of reseach/ ethical committee
City
Tabriz
Postal code
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
9342

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
Quality of Life
Timepoint
َAt first and at the seventh day of the study
Method of measurement
EORTC QLQ-C30 questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Patients were advised to mix one full spoon of honey with one teaspoon full cinnamon in boiling water and to be take it 3 times a day for one week
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital/Tabriz
Full name of responsible person
Dawood Aghamohammadi
Street address
Daneshghah street, Imam Reza Hospital
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Faculty of Medicine,Tabriz University of Medical Sciences
Full name of responsible person
Hassan Soleimanpour
Street address
Vice Chancellor for Research-Tabriz University of Medical Sciencest- Daneshghah Street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Faculty of Medicine,Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Anesthesiology Dept, Faculty of Medicine, Tabriz University of Medical Science
Full name of responsible person
Dawood Aghamohammadi
Position
Associate Professor
Other areas of specialty/work
Street address
Anesthesiology Dept, Faculty of Medicine, Tabriz University of Medical Science
City
Tabriz
Postal code
Phone
+98 41 3381 8940
Fax
Email
aghamohammadid@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Anesthesiology Dept, Faculty of Medicine, Tabriz University of Medical Science
Full name of responsible person
Dawood Aghamohammadi
Position
Associate Professor
Other areas of specialty/work
Street address
Anesthesiology Dept,Faculty of Medicine, Tabriz University of Medical Science
City
Tabriz
Postal code
Phone
+98 41 3381 8940
Fax
Email
aghamohammadid@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Anesthesiology Dept, Faculty of Medicine, Tabriz University of Medical Science
Full name of responsible person
Dawood Aghamohammadi
Position
Associate Professor
Other areas of specialty/work
Street address
Anesthesiology Dept, Faculty of Medicine, Tabriz University of Medical Science
City
Tabriz
Postal code
Phone
+98 41 3381 8940
Fax
Email
aghamohammadid@tbzmed.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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