Protocol summary

Study aim
Determining the effect of nutritional counseling on the nutritional status and quality of life of head and neck cancer patients undergoing radiotherapy
Design
In this randomized controlled clinical trial study, phase 2, 200 eligible patients are divided into two groups. The rand function of Excel software was used for randomization. The first group (control) who are treated with radiotherapy. . In the second group (intervention), before the start of radiotherapy, patients are given nutrition counseling . The intervention consists of an individual nutrition consultation every 2 weeks during treatment.
Settings and conduct
Cancer Institute Clinic, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences
Participants/Inclusion and exclusion criteria
Inclusion criteria 1. Patients who have been diagnosed with head and neck SCC cancer at T2-T4 stage along with lymph node involvement and are undergoing adjuvant or radical radiotherapy based on the radio-oncologist's diagnosis. 2. Adult patients over 18 years old 3. Patients on oral nutrition. exclusion criteria: 1. People who receive enteral or parenteral nutrition before or during the study 2. Patients with uncontrolled acute underlying diseases such as kidney and liver failure 2. receiving any other supportive treatment • Patients who die during radiotherapy. • Patients who do not continue the study for any reason.
Intervention groups
The first group (control) who are treated with oral cavity and neck radiotherapy, in the second group (intervention), before the start of radiotherapy, the patients are given nutrition counseling at the beginning of the treatment. The intervention consists of an individual nutrition consultation every 2 weeks during treatment.
Main outcome variables
Nutritional status through PG-SGA questionnaire and weight and quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240625062249N1
Registration date: 2024-08-22, 1403/06/01
Registration timing: prospective

Last update: 2024-08-22, 1403/06/01
Update count: 0
Registration date
2024-08-22, 1403/06/01
Registrant information
Name
Mahsa Malekahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 125 0467
Email address
malekahmadimahsa@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2025-06-21, 1404/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of regular nutrition consult on treatment tolerance and quality of life of patients with head and neck squamous cell carcinoma undergoing radiotherapy
Public title
Evaluation of the effect of nutrition consult in patients with head and neck squamous cell carcinoma undergoing radiotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have been diagnosed with head and neck SCC cancer in T2-T4 stage along with lymph node involvement and are undergoing adjuvant or radical radiotherapy based on the radio-oncologist's diagnosis. Adult patients over 18 years old Patients on oral nutrition.
Exclusion criteria:
People who receive enteral or parenteral nutrition before or during the study Patients with uncontrolled acute underlying diseases such as kidney failure and liver failure (high serum levels of urea and creatinine and decrease in GFR, increase in liver enzymes ALT, AST, ALP) receiving any other supportive treatment Patients who die during radiotherapy Patients who do not continue the study for any reason.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 200
Randomization (investigator's opinion)
Randomized
Randomization description
After confirming the criteria for entering the study and obtaining written informed consent , the required measurements will be performed on all subjects at the beginning of the study. Then the patients are placed in double blocks based on the type of head and neck cancer and BMI (±2) and then randomly assigned to the intervention group with a one-to-one ratio (nutrition counseling according to the necessary recommendations based on existing guidelines every two weeks) and control will be allocated. Randomization will be done by someone outside the research team.
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
Research Ethics Committee of Faculty of Medicine of Tehran University of Medical Sciences
Street address
Ghods street
City
Tehran
Province
Tehran
Postal code
1234567890
Approval date
2024-06-02, 1403/03/13
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1403.097

Health conditions studied

1

Description of health condition studied
head and neck squamous cell carcinoma
ICD-10 code
C44.32
ICD-10 code description
Squamous cell carcinoma of skin of other and unspecified parts of face

Primary outcomes

1

Description
weight
Timepoint
Before the intervention and every two weeks until the end of the intervention
Method of measurement
scales

2

Description
body mass index
Timepoint
Before the intervention and every two weeks until the end of the intervention
Method of measurement
formula

3

Description
mid arm circumference
Timepoint
Before the intervention and every two weeks until the end of the intervention
Method of measurement
tape measure

4

Description
calf circumferences
Timepoint
Before the intervention and every two weeks until the end of the intervention
Method of measurement
tape measure

5

Description
EORTC QLQ-C۳۰ score
Timepoint
The beginning and end of the intervention
Method of measurement
questionnaire

6

Description
PG-SGA score
Timepoint
The beginning and end of the intervention
Method of measurement
questionnaire

Secondary outcomes

1

Description
Complete blood count (CBC) measurement
Timepoint
Before and at the end of the intervention
Method of measurement
patient file

2

Description
serum albumin
Timepoint
Before and at the end of the intervention
Method of measurement
Autoanalyzer device (spectrophotometry method)

3

Description
total protein
Timepoint
Before and at the end of the intervention
Method of measurement
Autoanalyzer device (spectrophotometry method)

4

Description
The level of electrolytes
Timepoint
Before and at the end of the intervention
Method of measurement
spectrophotometry

5

Description
Local recurrence rate
Timepoint
at the end of the intervention
Method of measurement
Radiography

6

Description
Two-year disease-free survival
Timepoint
Two years after the intervention
Method of measurement
patient file

7

Description
Treatment tolerance (finishing the course of radiotherapy without interruption due to physical weakness)
Timepoint
at the end of the intervention
Method of measurement
patient file

Intervention groups

1

Description
Control group: The nutritional advice of the patient was at the level of nutritional recommendations to reduce nutritional complications related to radiotherapy.
Category
Treatment - Other

2

Description
Intervention group: • The nutritional counseling of the patient will be under the supervision of a nutritionist so that, in addition to nutritional recommendations, a suitable diet plan can be set to deal with the side effects of radiotherapy.• Use of nutritional supplements: to provide essential calories and nutrients, especially if the patient cannot consume enough food.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Cancer Institute of Imam Khomeini Hospital Complex, Tehran
Full name of responsible person
Reza Ghale Taki
Street address
Gharib st
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 913 125 0467
Email
malekahmadimahsa@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbari Sari
Street address
Ghods st
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 81631
Email
tumspr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mahsa Malekahmadi
Position
expert
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Gharib st
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 913 125 0467
Email
malekahmadimahsa@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahsa Malekahmadi
Position
expert
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Gharib st
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 913 125 0467
Email
malekahmadimahsa@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahsa Malekahmadi
Position
expert
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Gharib st
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 913 125 0467
Email
malekahmadimahsa@gmail.com

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
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