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Efficacy of medical nutrition therapy vs. general dietary advices on nutritional status of esophageal cancer patients receiving concurrent neo-adjuvant chemo-radiation

Protocol summary

Summary
This is a randomized controlled trial which is planned to perform in Reza radiation Oncology Centre (RROC), Mashhad. Pathologically proven esophageal cancer patients who meets the inclusion/exclusion criteria referred to RROC will be enrolled. All patients will fill the consent. For each patient a random number in a closed pocket will be allocated and they will be divided in two groups of intervention and control by random allocation using pocket method. Intervention group will receive specific medical nutrition therapy as their individual needs including dietary advises, oral nutrition support or enteral nutrition or parenteral nutrition. Control group will receive routine care and general dietary advises. The information will be gotten 3 times including before chemo-radiation, after chemo-radiation and 4 to 6 weeks after chemo-radiation, before surgery, which include demographic data, nutritional status of patients including Patient Generated-Subjective Global Assessment tool (PG-SGA), 3 days 24 hour recall, anthropometric measurements, body composition by Bio-electric Impedance Analysis, clinical symptoms associated with digestion and blood and biochemical factors (including total lymphocyte count, total protein, albumin, hs-CRP, urea, creatinine, SGOT, SGPT, cholesterol, triglyceride, HDL, LDL, and pro-inflammatory and anti- inflammatory cytokines. Other contributing factors of nutritional status of patients will also be assessed including socio-economic status, disease related factors, drug history, quality of life, psychological status. Three months after intervention, survival of patients will be asked.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016112931161N1
Registration date: 2017-06-25, 1396/04/04
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-06-25, 1396/04/04
Registrant information
Name
Sara Movahed
Name of organization / entity
Mashhad Uneversity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2417
Email address
movahheds921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Mashhad University of Medical Sciences Cancer Research Center of Mashhad University of Medical Sciences Reza Radiation Oncology Center
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of medical nutrition therapy vs. general dietary advices on nutritional status of esophageal cancer patients receiving concurrent neo-adjuvant chemo-radiation
Public title
Efficacy of nutrition therapy on treating esophageal cancer patients
Purpose
Treatment
Inclusion/Exclusion criteria
All patients 18 years old and more referred to Reza Radiation Oncology Center which esophageal cancer is proven pathologically and agree to participate and fill the consent, will be enrolled. Patients who are end stage (who have metastasis, trachea, mediastinal main vessels or vertebra involvement), receive palliative care, history of other cancers, esophageal surgery, concurrent disabling diseases such as CHF, CRF, COPD, Liver failure, AIDS or active rheumatic diseases and also subjects who cannot fill the questionnaires will not be enrolled. patients who do not desire to continue cooperation in study will be excluded.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Daneshgah St., Qoreishi Building
City
mashhad
Postal code
9138813944
Approval date
2016-08-17, 1395/05/27
Ethics committee reference number
IR.MUMS.REC.1395.111

Health conditions studied

1

Description of health condition studied
esophagus cancer
ICD-10 code
C15
ICD-10 code description
Malignant neoplasm of esophagus

Primary outcomes

1

Description
nutritional Status
Timepoint
before radiotherapy, after radiotherapy, 4 to 6 weeks after radiotherapy
Method of measurement
PG-SGA tool (questionnaire)

Secondary outcomes

1

Description
patient weight
Timepoint
Before radiotherapy, after radiotherapy, 4 to 6 weeks after radiotherapy
Method of measurement
weight scale

Intervention groups

1

Description
Intervention: Medical nutrition therapy including dietary advises, oral nutrition support or enteral nutrition or parenteral nutrition according to patients' nutritional status and signs and symptoms related to ingestion ability.
Category
Treatment - Other

2

Description
Control group: General dietary advice
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Reza Radiation Oncology Center
Full name of responsible person
Dr. Fatemeh Varshoee Tabrizi
Street address
Misaq 19, Misaq highway, Vakil abad Blvd
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Daneshgah St., Qoreishi Building
City
Mashhad
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 of Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Sara Movahed
Position
MD. PhD. candidate of nutrition sciences
Other areas of specialty/work
Street address
nutrition department, Faculty of Medicine, Azadi Square, Pardis Campus
City
Mashhad
Postal code
9177948564
Phone
+98 51 3880 2417
Fax
+98 51 3800 2421
Email
movahheds921@mums.ac.ir
Web page address
www.mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Abdloreza Norouzy
Position
Associate professor of nutrition sciences
Other areas of specialty/work
Street address
Department of Nutrition, Mashhad Medical School, Paradise Daneshghah, Azadi Square
City
Mashhad
Postal code
9177948564
Phone
+98 51 3800 2382
Fax
+98 51 3800 2421
Email
norouzya@mums.ac.ir
Web page address
www.mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sara Movahed
Position
MD. PhD. candidate of nutrition sciences
Other areas of specialty/work
Street address
Nutrition department, Faculty of Medicine, Azadi Square, Pardis Campus,
City
Mashhad
Postal code
9177948564
Phone
+98 51 3800 2417
Fax
+98 51 3800 2421
Email
movahheds921@mums.ac.ir
Web page address
www.mums.ac.ir

Sharing plan

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