The effect of synbiotic supplementation on dietary intake, nutritional status, quality of life, serum matrix metalloproteinase, serum inflammatory factors(TNFα,IL-6) and side effect of treatments in rectal patients undergoing neoadjuvant chemoradiotherapy
Objectives: effects of synbiotic supplementation on dietary intake،nutritional status, quality of life, serum Matrix Metalloproteinase enzymes,serum inflammatory markers levels(TNFα,IL-6) and side effects of treatment in rectal cancer patients undergoing neoadjuvant chemoradiotherapy. Design: Double blind randomized clinical trial. Setting and conduct: forty-six rectal cancer patients who refer for preoperative radiotherapy combined with chemotherapy comprising Fluorouracil regimen administrated concurrently with the first and the last 5 days of radiotherapy will be randomly divided into two groups intervention (synbiotic) and control (placebo). Participants including major eligibility criteria: volunteer rectal cancer patients in stage 2 and 3. Intervention: Intervention group: consume 2 capsules daily for 6 weeks (1 week before starting radiotherapy to the end of radiotherapy) and control group: placebo as 2 capsules daily for 6 weeks. Main outcome measures: body weight, dietary intake,nutritional status, quality of life,serum CEA level, serum CRP,TNFα and IL-6 levels, serum Matrix Metalloproteinase-2 (MMP-2) and Matrix Metalloproteinase-9 (MMP- 9) levelsand side effects of treatment
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT201503181197N18
Registration date:2015-06-14, 1394/03/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-14, 1394/03/24
Registrant information
Name
Reza Mahdavi
Name of organization / entity
Faculty of Health & Nutrition, Tabriz UniV. of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7584
Email address
mahdavir@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Nutritional Research Center, Tabriz University of Medical Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of synbiotic supplementation on dietary intake, nutritional status, quality of life, serum matrix metalloproteinase, serum inflammatory factors(TNFα,IL-6) and side effect of treatments in rectal patients undergoing neoadjuvant chemoradiotherapy
Public title
The effects of synbiotic supplementation on dietary intake،nutritional status, quality of life, serum Matrix Metalloproteinase enzymes,serum inflammatory markers levels(TNFα,IL-6) and side effects of treatment in rectal cancer patients undergoing neoadjuvant chemoradiotherapy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients with rectal cancer in stage 2 and 3 undergoing preoperative radiotherapy combined with chemotherapy.
Exclusion criteria: clinically relevant pulmonary; cardiovascular; hepatic and kidney dysfunction; immunological disorders; pregnancy; lactation; ongoing or recent infections (within last 30 d); body mass index less than 18.5 ; treatment with anticoagulants; taking antibiotics in the last 3 week; usage of Probiotics or prebiotics or synbiotic and mineral supplements; intolerance of synbiotic supplement.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
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 Tabriz University of Medical Sciences
Before radiotherapy and at the end of intervention(6 weeks)
Method of measurement
Immunoturbidimetry
Secondary outcomes
1
Description
Dietary intake
Timepoint
Before radiotherapy and at the end of intervention(6 weeks)
Method of measurement
24 hour food recall and dietary record questionnaire
2
Description
Quality of life
Timepoint
Before radiotherapy and at the end of intervention(6 weeks)
Method of measurement
QLQ-30 questionnaire
3
Description
Serum Matrix Metalloproteinases 2 ,9 (MMP-2,9)
Timepoint
Before radiotherapy and at the end of intervention(6 weeks)
Method of measurement
MMP-2,9;kit
4
Description
Added at 2016-02-28: side effects of treatment
Timepoint
Added at 2016-02-28: before radiotherapy and at the end of intervention
Method of measurement
Added at 2016-02-28: PG-SGA and WHO toxicity criteria questionnaire
Intervention groups
1
Description
Intervention group: Protexin synbiotic capsules ( 2 x 108 CFU Lactobacillus casei, Lactobacillus rhamnosus, Streptococcus thermophilus, Bifidobacterium breve, Lactobacillus acidophilus,
Bifidobacterium longum, Lactobacillus bulgaricus and fructooligosaccharide ), 2 capsules a day for 6 weeks . The supplementation begins 1 week before starting radiotherapy to the end of radiotherapy.
Category
Prevention
2
Description
Control group: 2 placebo capsules a day for 6 weeks.
The intervention begins 1 week before starting radiotherapy to the end of radiotherapy.