The effects of curcumin on serum inflammatory cytokines and quality of life in patients with colorectal cancer under chemotrapy in comparison with placebo group
The effects of curcumin on serum concentrations of inflammatory and anti-inflammatory cytokines in patients with colorectal cancer under chemotherapy
Design
The current study is a randomized, double-blind, placebo-controlled clinical trial with parallel groups. A total of 72 subjects were recruited between April 2018 and December 2018.
Settings and conduct
Patients with colorectal cancer who referred to Baqiyatallah Oncology Clinic were enrolled in the study. All volunteers, care providers and statistician were blinded after assignment to intervention. So that, the capsules containers were coded as A and B by a non-researcher person and remained confidential until statistical analysis. The placebo capsules were similar to the drugs regarding the weight and color.
Participants/Inclusion and exclusion criteria
Patients with colorectal cancer aged more than 20 years; Colorectal cancer patients (stage 3) who have undergone surgery and need chemotherapy
Intervention groups
1) Drug: a group receiving liposomal curcumin capsules (500 mg/day) for 8 weeks, 2) Placebo: the control group who taking a placebo capsule for a period of 8 weeks.
Main outcome variables
Tumor necrosis factor alpha; Interleukin 6; Quality of life score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080901001165N43
Registration date:2020-03-13, 1398/12/23
Registration timing:retrospective
Last update:2020-03-13, 1398/12/23
Update count:0
Registration date
2020-03-13, 1398/12/23
Registrant information
Name
Yunes Panahi
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8821 1524
Email address
yunespanahi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
2018-04-21, 1397/02/01
Actual recruitment end date
2018-12-31, 1397/10/10
Trial completion date
2018-12-31, 1397/10/10
Scientific title
The effects of curcumin on serum inflammatory cytokines and quality of life in patients with colorectal cancer under chemotrapy in comparison with placebo group
Public title
The Effects of Curcumin on Patients with Colorectal Cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with colorectal cancer aged more than 20 years
Colorectal cancer patients (stage 3) who have undergone surgery and need chemotherapy
Exclusion criteria:
Age less than 20 years
Patients who need a change of the treatment
Age
From 20 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
32
Actual sample size reached:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly assigned to one of the treatment groups based on random allocation sequence generated by a statistician: 1) Drug: a group receiving liposomal curcumin capsules (500 mg/day) for 8 weeks (n=36), 2) Placebo: the control group who taking a placebo capsule for a period of 8 weeks (n=36).
The tables of the Fleiss book were used to generate the random allocation sequence. The allocation scheme was consecutively numbered in envelopes which opened sequentially by an independent person, not involved in the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
All volunteers, care providers and statistician were blinded after assignment to intervention. So that, the capsules containers were coded as A and B by a non-researcher person and remained confidential until statistical analysis. The placebo capsules were similar to the drugs regarding the weight and color.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallah University of Medical Sciences,Tehran, Iran
Before the intervention and 8 weeks after taking drug or placebo
Method of measurement
Sandwich and competitive chemiluminescence immunoassays
2
Description
Interleukin 6
Timepoint
Before the intervention and 8 weeks after taking drug or placebo
Method of measurement
Sandwich and competitive chemiluminescence immunoassays
3
Description
Total quality of life score
Timepoint
Before the intervention and 8 weeks after taking drug or placebo
Method of measurement
Using EORTC QLQ questionnaire
Secondary outcomes
1
Description
Interleukin 1 alpha
Timepoint
Before the intervention and 8 weeks after taking drug or placebo
Method of measurement
Sandwich and competitive chemiluminescence immunoassays
2
Description
Interleukin 1 beta
Timepoint
Before the intervention and 8 weeks after taking drug or placebo
Method of measurement
Sandwich and competitive chemiluminescence immunoassays
3
Description
Interleukin 2
Timepoint
Before the intervention and 8 weeks after taking drug or placebo
Method of measurement
Sandwich and competitive chemiluminescence immunoassays
4
Description
Interleukin 4
Timepoint
Before the intervention and 8 weeks after taking drug or placebo
Method of measurement
Sandwich and competitive chemiluminescence immunoassays
5
Description
Interleukin 8
Timepoint
Before the intervention and 8 weeks after taking drug or placebo
Method of measurement
Sandwich and competitive chemiluminescence immunoassays
6
Description
Interleukin 10
Timepoint
Before the intervention and 8 weeks after taking drug or placebo
Method of measurement
Sandwich and competitive chemiluminescence immunoassays
7
Description
Monocyte chemoattractant protein
Timepoint
Before the intervention and 8 weeks after taking drug or placebo
Method of measurement
Sandwich and competitive chemiluminescence immunoassays
8
Description
Interferon gama
Timepoint
Before the intervention and 8 weeks after taking drug or placebo
Method of measurement
Sandwich and competitive chemiluminescence immunoassays
9
Description
Epidermal growth factor
Timepoint
Before the intervention and 8 weeks after taking drug or placebo
Method of measurement
Sandwich and competitive chemiluminescence immunoassays
10
Description
Vascular endothelial growth factor
Timepoint
Before the intervention and 8 weeks after taking drug or placebo
Method of measurement
Sandwich and competitive chemiluminescence immunoassays
11
Description
Selectin
Timepoint
8 weeks after taking drug or placebo
Method of measurement
Enzyme Linked Immunosorbent Assay
12
Description
Intercellular Adhesion Molecule 1
Timepoint
8 weeks after taking drug or placebo
Method of measurement
Enzyme Linked Immunosorbent Assay
13
Description
Vascular Cell Adhesion Molecule 1
Timepoint
8 weeks after taking drug or placebo
Method of measurement
Enzyme Linked Immunosorbent Assay
14
Description
C Reactive Protein
Timepoint
Before the intervention and 8 weeks after taking drug or placebo
Method of measurement
Using Auto analyzer and Bio system Kit
Intervention groups
1
Description
Intervention group: Subjects in the intervention group receive curcumin-piperine capsules (daily intake of 500 mg curcumin plus 5 mg piperine) for 8 weeks (n=36). The participants take one capsule every day, which was contained in an unlabeled bottle. Capsules are from Sami Labs company (Bangalore, India).
Category
Treatment - Drugs
2
Description
Control group: Placebo capsules are prepared by a similar company and are similar to the curcumin capsules regarding the color, shape and size. The control group receive a placebo capsule containing lactose plus 5 mg piperine for a period of 8 weeks (n=36). The participants take one capsule every day, which was contained in an unlabeled bottle. Capsules are from Sami Labs company (Bangalore, India).