Protocol summary

Summary
The aim of study is to evaluate the effect of oral administration of propolis on nutritional status, enzymes, matrix metalloproteinases, inflammatory, anti-inflammatory and oxidative markers and quality of life of breast cancer patients will be treated with chemotherapy. Study is the double blind clinical trial and study population are patients with stage II and III breast cancer after surgery which will undergoing chemotherapy. 70 volunteer patients aged 30-50 years with breast cancer will be referred to Tohid Hospital undergoing chemotherapy standard treatment, chemotherapy with the same drugs (adriamycin Neoadjuvant regimen of 60 mg / m2 and cyclophosphamide 600 mg / m2, four Paclitaxel training session once every two weeks and 175 mg / m2 every 3 weeks for four courses), will be included. Patient will be divided in to placebo and propolis group with Block Randomized sampling. A week before the start of chemotherapy, Propolis will be administered in dose of 250 mg twice a day until the end of treatment (3 months) and control group will be received a placebo. Groups’ anthropocentric data, dietary intake, nutritional status, quality of life, factors affecting appetite and blood samples will be collected before and after the intervention. Serum levels of interleukins b1,2, 10, TNF-α and oxidant-antioxidant balance, matrix metalloproteinases enzymes 2 and 9, at baseline and after the intervention will be measured. Blinding will be done for the intervention and placebo groups and reviewers of the study’s variables.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016062828679N1
Registration date: 2016-09-08, 1395/06/18
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-09-08, 1395/06/18
Registrant information
Name
Seyed Hossein Davoodi
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2235 7483
Email address
hdavoodi1345@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
1.Cancer Research Center, Shahid Beheshti University of Medical Sciences.2. Research Deputy, Kurdistan University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Propolis intake on nutritional status, matrix metalloproteinase enzymes, inflammatory, anti-inflammatory and oxidative factors and quality of life in patients with Breast Cancer undergoing chemotherapy.
Public title
Effects of Propolis intake on nutritional status, some inflammatory and anti-inflammatory factors and quality of life in patients with Breast Cancer undergoing chemotherapy.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Stage II and III Breast cancer under chemotherapy; age range 30 to 50 years. Exclusion criteria: heart disease co morbidity; history of hypersensitivity reactions to bee products.
Age
From 30 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Opposite of Shadi Hotel, Pasdaran Str
City
Sanandaj
Postal code
Approval date
2016-06-13, 1395/03/24
Ethics committee reference number
1395/93

Health conditions studied

1

Description of health condition studied
Breast Cancer
ICD-10 code
C50.9
ICD-10 code description
Malignant neoplasm: Breast, unspecified

Primary outcomes

1

Description
Interlukin b1, 2, 10
Timepoint
Baseline and after intervention
Method of measurement
Elisa, ng/ml

2

Description
TNF-α
Timepoint
Baseline and after intervention
Method of measurement
Elisa, ng/ml

3

Description
MMP-2, 9
Timepoint
Baseline and after intervention
Method of measurement
Elisa, ng/ml

4

Description
Anti oxidant Ezymes
Timepoint
Baseline and after intervention
Method of measurement
Elisa, nmol/l

5

Description
Nutritional Status
Timepoint
Baseline and after intervention
Method of measurement
PGSGA questionner

6

Description
mir 21
Timepoint
Baseline and after intervention
Method of measurement
Fold

7

Description
mir638
Timepoint
Baseline and after intervention
Method of measurement
Fold

8

Description
quality of life
Timepoint
Baseline and after intervention
Method of measurement
EORTC QLQ30

Secondary outcomes

1

Description
Chemotrapy Complication
Timepoint
Baseline and after intervention
Method of measurement
questionner

2

Description
Liver Enzymes
Timepoint
Baseline and after intervention
Method of measurement
Eliza, IU/L

Intervention groups

1

Description
A week before the start of chemotherapy in intervention group, 250 mg propolis extract divided in two 125 mg capsules will administered twice daily with breakfast and lunch until the end of treatment (3 months).
Category
Treatment - Drugs

2

Description
A week before the start of chemotherapy in the placebo group, starch capsules with dose of 250 mg (125 mg twice daily) will administered with breakfast and lunch until the end of treatment (3 months)
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Tohid Hospital of Sanandaj
Full name of responsible person
Dr Bayezid Ghaderi
Street address
Oncology Ward, Tohid Hospital, Gheryashan Blvd
City
Sanandaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Reaerch Deputy of Kurdistan University of Medical Sciences
Full name of responsible person
Dr Ebrahim Ghaderi
Street address
Pasdaran Str, Reaerch Deputy of Kurdistan University of Medical Sciences
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Reaerch Deputy of Kurdistan 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nazila Darvishi
Position
PhD Candidate of Nutrition
Other areas of specialty/work
Street address
No 23, Gole Narges Alley, Hafez Str
City
Sanandaj
Postal code
Phone
+98 87 3366 9313
Fax
Email
naziladarvishy@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nazila Darvishi
Position
PhD Candidate of Nutrition
Other areas of specialty/work
Street address
No 23, Gole Narges Alley, Hafez Str
City
Sanandaj
Postal code
Phone
+98 87 3366 9313
Fax
Email
naziladarvishy@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid beheshti University of Medical Sciences
Full name of responsible person
Nazila Darvishi
Position
PhD Candidate of Nutrition
Other areas of specialty/work
Street address
No 23, Hafez Str, Gol Nages Alley
City
Sanandaj
Postal code
Phone
+98 87 3366 9313
Fax
Email
naziladarvishy@yahoo.com
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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