The effect of nutritional consultant on reduce the gastrointestinal complications
Design
After confirming the inclusion criteria and obtain written inform consent, patients were randomly allocating into two groups (using table of random numbers and sealed envelopes used to hide). In the first or intervention group educational program will be given to the patient by the researcher during 3 sessions of an hour in three times a week (during two weeks) and second or non-intervention group, intervention not given. Sample size in study is 80.
Settings and conduct
Patients that referred to Towhid Hospital in Sanandaj city will included in study. After confirming the inclusion criteria and obtain written inform consent, patients were randomly allocating into two groups (using table of random numbers and sealed envelopes used to hide). This trial is double blind.
Participants/Inclusion and exclusion criteria
The inclusion criteria is following:Mean age 84 18 years، Diagnostic abdominal and pelvic cavity cancer pathology،Receive abdominal and pelvic cavity radiotherapy، Patients should be at least one-week radiotherapy.
Exclusion criteria is following:
Patients with colon cancer
Chronic digestive disorders
The history of Gluten and Celiac intolerance
Intervention groups
Intervention group: will be given nutritional consultant to the patient by the researcher during 3 sessions of an hour in three times a week (during two weeks), individually and face-to-face at the Radiotherapy Hospital of Tohid Hospital.
Control group:
In this group intervention will not done.
Main outcome variables
Nausea,
Vomiting,
Abdominal bloating,
Diarrhea and Constipation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180610040031N1
Registration date:2019-04-12, 1398/01/23
Registration timing:registered_while_recruiting
Last update:2019-04-12, 1398/01/23
Update count:0
Registration date
2019-04-12, 1398/01/23
Registrant information
Name
rozhin khateri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3557 2282
Email address
khateri.r@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-04, 1398/01/15
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of nutritional consultation on gastrointestinal complications in patients undergoing radiotherapy of abdominal and pelvic cavity cancer
Public title
The effect of nutritional consultation on gastrointestinal complications
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 84 -18 years
Diagnostic abdominal and pelvic cavity cancer pathology
Receive abdominal and pelvic cavity radiothrapy
Patients should be at least one-week radiotherapy
Exclusion criteria:
Patients with colon cancer
Chronic digestive disorders
The history of Gluten and Celiac intolerance
Age
From 18 years old to 84 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
After confirming the inclusion criteria and obtain written inform consent, patients were randomly allocate into two groups (using table of random numbers).
Blinding (investigator's opinion)
Double blinded
Blinding description
Opaque sealed envelopes numbered sequentially with the group type written in them will used for allocation concealment. The envelopes will prepared by a researcher not involved in data collection. The envelopes will opened after completing the pre-intervention questionnaires. Therefore, before random assignment of participants, outcome assessor and participants will unaware of what participants were assigned to each group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kurdistan University of Medical Sciences, Kurdistan ,Iran
Street address
Head on Hotel Shadi, Pasdaran Street, Kurdistan
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Approval date
2019-01-19, 1397/10/29
Ethics committee reference number
IR.MUK.REC.1397.286
Health conditions studied
1
Description of health condition studied
Abdominal cancer
ICD-10 code
C76.2
ICD-10 code description
Malignant neoplasm of other and ill-defined sites (Abdomen)
2
Description of health condition studied
Pelvic cancer
ICD-10 code
C76.3
ICD-10 code description
Malignant neoplasm of other and ill-defined sites (Pelvis)
Primary outcomes
1
Description
Nausea
Timepoint
After intervention
Method of measurement
Gastrointestinal Symptom Rating Scale
2
Description
Vomiting
Timepoint
After intervention
Method of measurement
Gastrointestinal Symptom Rating Scale
3
Description
Abdominal bloating
Timepoint
After intervention
Method of measurement
Gastrointestinal Symptom Rating Scale
4
Description
Diarrhea
Timepoint
After intervention
Method of measurement
Gastrointestinal Symptom Rating Scale
5
Description
Constipation
Timepoint
After intervention
Method of measurement
Gastrointestinal Symptom Rating Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: educational consultation will be given to the patient by the researcher during 3 sessions of an hour a week (during two weeks).
Category
Prevention
2
Description
Control group: intervention not given.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Towhid hospital
Full name of responsible person
Rozhin Khateri
Street address
Towhid hospital, Graishian St.
City
Sanandaj
Province
Kurdistan
Postal code
6616812131
Phone
+98 87 3557 2282
Email
khateri.r@muk.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Ebrahim Ghaderi
Street address
Head on Hotel Shadi, Pasdaran Street, Kurdistan
City
Sanadaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4673
Email
ghaderie@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
rozhin khateri
Position
Student Master of Medical Surgical Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Head on Shadi Hotel, Pasdaran street, Kurdistan University of Medical Sciences, Kurdistan
City
Sanandaj
Province
Kurdistan
Postal code
666147 - 13446
Phone
+98 87 3557 2282
Email
khateri.r@muk.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Mokhtar Yaghobi
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Kurdistan, Kurdistan University of Medical Sciences, Sanandaj, Pasdaran steetT head on Shadi Hotel
City
Sanandaj
Province
Kurdistan
Postal code
666147 - 13446
Phone
+98 87 3182 7272
Email
mokhtar-yaghobi@muk.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Rozhin Khateri
Position
Student Master of Medical Surgical Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Head on Hotel Shadi, Pasdaran Street, Kurdistan, Iran
City
Sanandaj
Province
Kurdistan
Postal code
666147 - 13446
Phone
+98 87 3557 2282
Email
khateri.r@muk.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