Protocol summary

Summary
The present study aims to determine an appropriate individual diet therapy to improve breast cancer patients' nutritional status, to enhance their life quality and health level, to overcome their nutrition barriers and to reduce their medical expences. This study is a randomized clinical trial. The participants of the study must be woman over the age of 18 who have undergone chemotherapy once or three times, howere, those who have to follow a special diet plan, or suffer from diseases other tahn cancer will be excluded from the study. The participants of the study will be 70 woman who are going to be treated by a special nutritional diet therapy for about 2 months. Additionally, at the bigining and at the end of study, the chemotherapy side effects such as, anorexia, adnauseam, diarrhea, constipation, serum albumin, liver enzyme, ferritin, hemoglobin and alkalin phosphatose will be measured and compared between two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201607193236N7
Registration date: 2017-07-08, 1396/04/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-07-08, 1396/04/17
Registrant information
Name
Zohreh Mazloom
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 1008
Email address
zmazloom@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University Of Medical Sciences
Expected recruitment start date
2016-07-23, 1395/05/02
Expected recruitment end date
2016-09-20, 1395/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of individual diet therapy on the side effects of chemotherapy and the quality of life in patient with breast cancer
Public title
Individual diet therapy on prevention of the side effect of chemotherapy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria : Breast cancer patients receiving chemotherapy with fixed-position; age greather than 18 years old; persian Language; people who do not follow the specific treatment regime; Patients with metastatic breast cancer who are not exclusion criteria: People with diseases such as heart disease, diabetes or neurodegenerative diseases such as Parkinson's affects .
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand Blvd
City
Shiraz
Postal code
Approval date
2016-05-29, 1395/03/09
Ethics committee reference number
IR.SUMS.REC.1395.61

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
Inflammation of the mouth
Timepoint
befor and after intervention
Method of measurement
nutritional barriers questionnaire

2

Description
Change sense of taste and smell
Timepoint
befor and after intervention
Method of measurement
nutritional barriers questionnaire

3

Description
Diarrhea
Timepoint
befor and after intervention
Method of measurement
nutritional barriers questionnaire

4

Description
constipation
Timepoint
befor and after intervention
Method of measurement
nutritional barriers questionnaire

5

Description
dysphagia
Timepoint
befor and after interventtion
Method of measurement
nutritional barriers questionnaire

6

Description
loss of appetite
Timepoint
befor and after intervention
Method of measurement
nutritional barriers questionnaire

7

Description
weight change
Timepoint
befor and after intervention
Method of measurement
Balance - kg

8

Description
BMI
Timepoint
befor and after intervention
Method of measurement
weight devide into height2

9

Description
alb
Timepoint
befor and after intervention
Method of measurement
Standard enzymatic method

10

Description
SGOT,SGPT
Timepoint
befor and after intervention
Method of measurement
Standard enzymatic method

11

Description
alka.phos
Timepoint
befor and after intervention
Method of measurement
Standard enzymatic method

12

Description
ferritin
Timepoint
befor and after intervention
Method of measurement
Standard enzymatic method

13

Description
hb
Timepoint
befor and after intervention
Method of measurement
Standard enzymatic method

14

Description
malnutrition
Timepoint
befor and after intervention
Method of measurement
PG-SGA questionnaire

Secondary outcomes

1

Description
quality of life
Timepoint
befor and after intervention
Method of measurement
EROTIC-QLQ-C30 questionnaire

Intervention groups

1

Description
In the intervention group therapy interventions including diet and nutritional advice in 2 month and pamphlets are provided in the control group
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Motahari Clinic
Full name of responsible person
Kiana Parnian
Street address
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Dr Basir Hashemi
Street address
The Headquarters Of Shiraz University Of Medical Sciences, Opposite of Palestine Street, Zand Street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University Of Medical Sciences, Faculty Of Nutrition and Food Sciences
Full name of responsible person
Kiana Parnian
Position
Master of Science in Nutrition
Other areas of specialty/work
Street address
Department of Nutrition and Food Science, Razi blvd
City
Shiraz
Postal code
Phone
+98 713751005
Fax
Email
kiana.parnian.p@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences, Faculty of Nutrition and Food Sciences
Full name of responsible person
Dr Zohreh Mazloom
Position
PhD, nutritional sci - professor
Other areas of specialty/work
Street address
Department of Nutrition and Food Science, Razi blvd
City
Shiraz
Postal code
Phone
+98 71 3725 1001
Fax
Email
zohreh.mazloom@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences, Faculty of Nutrition and Food Sciences
Full name of responsible person
Kiana Parnian
Position
Master of Science in Nutrition
Other areas of specialty/work
Street address
Department of Nutrition and Food Science, Razi blvd
City
Shiraz
Postal code
Phone
00
Fax
Email
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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