Evaluation of the effect of captopril in the prevention of hand and foot syndrome and in patients with colon cancer
Ontology highlight
ABSTRACT:
DISEASE(S): Malignant Neoplasm Of Colon And Rectum,Colorectal Cancer,C18-19
PROVIDER: 2480495 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
Similar Datasets
Project description:Intervention 1: Intervention 1: a 50000 IU vitamin D perl, weekly+ 2 omega-3 fatty acid capsules, daily. Intervention 2: Intervention group 2: a 50000 IU vitamin D perl, weekly+ 2 omega-3 fatty acid placebo, daily. Intervention 3: Intervention group 3: two omega-3 fatty acid capsules+ a vitamin D placebo, weekly. Intervention 4: Control group: a vitamin D placebo, weekly+ 2 omega-3 fatty acid placebo, daily.
Primary outcome(s): Serum level of TNF-a. Timepoint: Before and 8 weeks after intervention. Method of measurement: Serum TNF-a levels will be assessed by ELISA and Bender Med kit (Bender Med, Germany).
Study Design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants were allocated randomly and by using a random number table, into one of four groups. Vitamin D, omega-3, and placebo tablets were placed into identical containers, and a person who is not involved in study protocol created the randomization list. All investigators, and participants were blinded to the random assignments, Blinding description: For blinding, study leader who is not involved in study protocol created the randomization list assigning participants to the vitamin D, omega-3, or the placebo group. Vitamin D, omega-3, and placebo tablets are placed into unlabeled identical containers. The study leader will label these containers with participant numbers using the randomization list. All investigators, and participants were blinded to the random assignments.
| 2496040 | ecrin-mdr-crc
Project description:Intervention 1: Intervention group: performing 6 week chemotherapy with mFOLFOX 6 or CapeOx and then carry out surgery and continue chemotherapy for 18 weeks. Intervention 2: Control group: Initial surgery followed by chemotherapy with mFOLFOX 6 or CapeOx for 24 weeks.
Primary outcome(s): Disease Free Survival. Timepoint: One year after intervention. Method of measurement: No relapse of cancer.;Histological response and down staging of tumor. Timepoint: After surgery. Method of measurement: Pathological and radiological examination.
Study Design: Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization on individuals was performed using a table of random numbers. Allocation concealment was carried out, Blinding description: The surgeon, pathologist and radiologist are unaware of allocated groups. Besides, the outcome assessor who evaluates the quality of life is unaware of the allocated groups. The data analyser will be blinded to the intervention groups.
| 2481605 | ecrin-mdr-crc
Project description:Intervention 1: Intervention 1: a 50000 IU vitamin D tablet (Zahravi, Iran), weekly+ 2 omega-3 fatty acid capsules (each capsule containing 330 mg omega-3 fatty acid) (Minami Nutrition, Belgium), daily, for 8 weeks. Intervention 2: Intervention group 2: a 50000 IU vitamin D tablet (Zahravi, Iran), weekly+ 2 omega-3 fatty acid placebo (Zahravi, Iran), daily, for 8 weeks. Intervention 3: Intervention group 3: two omega-3 fatty acid capsules (each capsule containing 330 mg omega-3 fatty acid) (Minami Nutrition, Belgium), daily+ a vitamin D placebo (Zahravi, Iran), weekly, for 8 weeks. Intervention 4: Control group: a vitamin D placebo (Zahravi, Iran), weekly+ 2 omega-3 fatty acid placebo (Zahravi, Iran), daily, for 8 weeks.
Primary outcome(s): Serum level of TNF-a. Timepoint: Before and 8 weeks after intervention. Method of measurement: Serum TNF-a levels will be assessed by ELISA and Bender Med kit (Bender Med, Germany).
Study Design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: For randomized allocation performing, permuted block randomization will be used by quadrilateral blocks. According to the sample size of 80 subjects, 20 blocks will be generated using the online site (www.sealedenvelope.com). In order to allocation concealment in the randomized process, unique codes will be used on the drug boxes that is generated by the software. Participants will enter based on the sequence produced into study and the drug packets with code registered will allocate to the individual. Therefore, before participants selection, they will be unaware of the type of intervention that will receive, as well as a random sequence produced during the study will be immune from prediction, Blinding description: For blinding, a person who is not involved in study protocol created the randomization list assigning participants to the vit
| 2475288 | ecrin-mdr-crc
Project description:Intervention 1: Intervention group: They will receive glutamine powder (Karen Company) in the form of 30 grams per day for 10 days before surgery. Intervention 2: Control group: They will receive placebo with starch content (Karen Company) for 10 days before surgery.
Primary outcome(s): Carcinoembryonic antigen. Timepoint: At the beginning of the study (10 days before surgery), and one month after surgery. Method of measurement: Quantitative electroluminescence.
Study Design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this experiment, the balanced random block method will be used, with a block size of 4 (combination of A and B as groups). Using the Randomization.com website, random allocation will be done for 200 people in the form of 50 blocks of 4. Since body mass index is an important variable in the intervention effect. This intervention will be implemented in a classified manner. In order to carry out this trial correctly, a random allocation list will be produced separately for each of the two classes of body mass index 18.5 to 25 and 25 to 30, Blinding description: One of the nurses will be responsible for randomly selecting patients and prescribing supplements for them. In order to carry out this research blindly, the supplements will be completely similar and closed in terms of appearance. Also, glutamine supplement and placebo are separated
| 94053 | ecrin-mdr-crc
Project description:Intervention 1: Intervention group: In this group, an intervention program is designed focusing on the components of the social Marketing Mix or 4P (product, price, place, promotion).This intervention program includes a set of communication, executive proceedings, educational and informational programs and Transfer effective messages through the preferred communication channels mentioned by the participants to reduce or eliminate barriers and create facilitators to perform the desired behavior, which is participation in fecal immunochemistry, is carried out for one month. To evaluate the effectiveness of the intervention program, three months and 6 months after the intervention, the level of participation in fecal immunochemistry is assessed and compared with the control group. Also, before the interventions and 3 months and 6 months after the interventions, refer to the experimental and control groups again and the champion questionnaire is completed and the mean score of health beliefs about colorectal cancer screening is determined and compared between the two groups. Intervention 2: Control group: In this group, any of the interventions of the intervention group is presented. If participation in this group recourse for a Fecal Immunochemistry test, the test will be done for them. At the end of the research, in order to comply with ethical issues, all the designed training materials will be provided to the control group.
Primary outcome(s): Colorectal Cancer Screening. Timepoint: Before, 3 and 6 months after the intervention. Method of measurement: Participation rate in Fecal Immunochemistry Test.;Health Beliefs. Timepoint: 3 and 6 months after the intervention. Method of measurement: Champion’s Health Belief Scale.
Study Design: Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Screening, Randomization description: Firstly, 200 samples with having inclusion criteria will be selected using a table of random numbers. Then, a random allocation software will be used to create 50 blocks with a block size of four. in order to create a list of block randomization, refer to following website is done:https://www.sealedenvelope.com/simple-randomiser/v1/lists. Then, based on this generated list (BABA, ABBA, BAAB, BABA, AABB, ...), the subjects will be allocated into the intervention (B) or control (A) groups, Blinding description: In order to perform blinding, assistant researcher who collects data before and after the intervention, as well as statistician who analyzes the data, are blinded to the groups and the assignment of individuals in the groups.
| 2482101 | ecrin-mdr-crc
Project description:Intervention 1: 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). Intervention 2: 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).
Primary outcome(s): Tumor necrosis factor alpha. Timepoint: Before the intervention and 8 weeks after taking drug or placebo. Method of measurement: Sandwich and competitive chemiluminescence immunoassays.;Interleukin 6. Timepoint: Before the intervention and 8 weeks after taking drug or placebo. Method of measurement: Sandwich and competitive chemiluminescence immunoassays.;Total quality of life score. Timepoint: Before the intervention and 8 weeks after taking drug or placebo. Method of measurement: Using EORTC QLQ questionnaire.
Study Design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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 c
| 2475013 | ecrin-mdr-crc
Project description:Intervention 1: Intervention group: Roy follow-up care model. Intervention 2: Control group: Chemotherapy and routine nursing and medical care that are applied on a daily basis, and does not receive a training program based on the Roy adaptation pattern.
Primary outcome(s): The severity of depression, anxiety and stress. Timepoint: First and 2 months after the intervention. Method of measurement: Roy review And recognition form and anxiety scale, depression, stress DASS-21.
Study Design: Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Randomization description: Blocks randomization method was used to allocate individuals to groups, Blinding description: the allocation of patients to the groups was done by a nurse in the department that have no information about the treatment of A or B group. (Hiding random allocation and staying out of the intervention group).
| 2488886 | ecrin-mdr-crc
Project description:Intervention 1: Intervention group1: Coloanal End to End Anastomosis. Intervention 2: Intervention group 2: Side to End Anastomosis. Intervention 3: Intervention group 3: J poach coloanal anastomosis.
Primary outcome(s): Surgery period. Timepoint: onset to end of anesthesia. Method of measurement: Minute.;Hospital Stay. Timepoint: Discharge Time. Method of measurement: day.;Blood Loss. Timepoint: ?End of surgery. Method of measurement: CC.
Study Design: Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple randomization of individual by randomly drawing sealed envelopes, using a computer-based table of randomization by a surgical assistant, Blinding description: In this single-blind study, the participants were not familiar with three types of anastomosis surgery in this study. In addition, the observer, who completed the questionnaire, was not familiar with the groups. Similarly, the data analyzer did not know the study groups. However, the main researcher (surgeon) was informed about the groups, and all surgical procedures were performed by the same surgeon. The safety and data monitoring committee was also informed about the study groups.
| 2485057 | ecrin-mdr-crc
Project description:Intervention 1: Intervention group: The intervention group is subjected to peer support interventions for one month, at least twice a week by phone, and at least weekly by the Internet (virtual network) at least once a week. Intervention 2: The control group receives the same routine care and there is no intervention in it.
Primary outcome(s): Subjective well-being Score, in the Warwick Edinburgh Questionnaire. Timepoint: Before the intervention and one month after the end of the intervention. Method of measurement: Warwick Edinburgh subjective well-being Questionnaire.
Study Design: Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients are randomly assigned to two groups of intervention and control (using the random numbers table at www.randomization.com), Blinding description: The analyst will be unaware of the intervention and control groups and the data collected and which group it relates to.
| 2498403 | ecrin-mdr-crc
Project description:Intervention 1: Intervention group: patients will receive 4 sachetes each contain of 500mg Rhamnus frangula extract which will dissolve in a liter of water. they will receive a glass every 6 hours 24 hours before the colonoscopy ,In order to prepare Rhamnus frangula sachet, frangula fruit will be purchased from reputable centers and then dried in a drying machine and ground in a special herb grinder and packed as a powder in the sachetes. Intervention 2: 2nd intervention group: . All patients will receive 4 sachetes of Pidrolax each dissolved in 1litre water and will take a glass every 20 minutes 24 hours before colonoscopy. Pidrolox sachets containing polyethylene glycol 4000 will belong to Sepidaj company.
Primary outcome(s): Bowel preparation score. Timepoint: after intervention. Method of measurement: BOSTON score.
Study Design: Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: From the patients who volunteered to participate in the study, 116 persons will be selected by simple random sampling. Randomization method:block Randomization unit : Individual Randomization layers: In each block, people will be matched based on age and gender. Random Allocation software: Random Allocation software How to create a random sequence: Using Random Allocation software Hide: The random sequence created is kept in a safe place and is done by an independent person who is not involved in the experiment during the study. Random allocation of hidden individuals, patients and researchers will not be aware of it, Blinding description: This study is a double-blind study in which the researcher of this study and the patients participating in the study will be unaware of the type of supplement received. Supplements
| 24456 | ecrin-mdr-crc