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A clinical trial to study the effects of coffee and chewing gum on return of normal bowel function after undergoing surgery for malignant tumors of female reproductive system.

ABSTRACT: Intervention1: Chewing gum: sugarless chewing gums to chew 3 times daily at 15:00, 19:00, and, 10.00 hours until initiation of solid diet or, for 2 days whichever is earlier, starting from the day of surgery itself, each session of chewing to last 30 minutes. Intervention2: Coffee: Coffee will be dispensed from a single vending machine using same brand of coffee capsules, containing fixed and known proportion of caffeine and other ingredients : to drink three cups of caffeinated coffee daily (100 mL at 08:00, 12:00, and 16:00), beginning on Post-operative day (POD) 1. Patients have to drink the entire 100 mL amounts within 20 min under the supervision of a nursing officer. This will be contined for 2 days or upto initiatiation of solid diet, whichever is earlier. Control Intervention1: nil intervention: This group will receive post-operative care in form of hydration, antibiotics, anti-emetics, thrombo-prophylaxis, ambulation as per department protocol. They will receive analgesia by means of epidural infusion, and, paracetamol (no opioids) Primary outcome(s): The time interval in hours between skin closure of surgery to first solid oral feedTimepoint: time when the patient takes first oral feed after surgery for first time Study Design: Randomized, Parallel Group, Placebo Controlled Trial Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:On-site computer system Blinding and masking:Open Label

DISEASE(S): Malignant Neoplasm Of Overlappingsites Of Corpus Uteri,Malignant Neoplasm Of Uterus, Partunspecified,Malignant Neoplasm Of Fundus Uteri,Malignant Neoplasm Of Cervix Uteri, Unspecified,Malignant Neoplasm Of Endocervix,Malignant Neoplasm Of Right Ovary,Malignant Neoplasm Of Endometrium,Malignant Neoplasm Of Left Ovary,Malignant Neoplasm Of Overlappingsites Of Cervix Uteri,Malignant Neoplasm Of Overlappingsites Of Female Genital Organs,Malignant Neoplasm Of Placenta,Malignant Neoplasm Of Unspecifiedovary,Malignant Neoplasm Of Myometrium,Malignant Neoplasm Of Exocervix,Malignant Neoplasm Of Corpus Uteri, Unspecified,Malignant Neoplasm Of Isthmus Uteri

PROVIDER: 2603566 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:To study the molecular mediators of naturally rewarding effects of palatable food we used a model of palatable âsnackingâ (Ulrich-Lai et al., 2007) in which rats are given chronic, brief access to a limited amount of sucrose solution (30%). Single housed, male Long-Evans rats (250g) (n=12 per group) from Harlan Labs (Indianapolis, IN) received normal rat chow (Harlan Teklad) and water ad libitum for the duration of the experiment. After a one-week period of acclimation, rats were randomly assigned to drink treatment groups of either 30% sucrose solution or water. Rats received a 14-day regimen of twice daily (9:30 and 15:30) brief (maximum of 30 minutes) limited (up to 4 mL) access of their assigned drink solution. Drink solutions were delivered via a graduated sipper placed onto the cage top in addition to the existing water bottle and sippers were immediately removed when the animal had consumed 4mL or after the 30-minute access period, whichever occurred first. Drink intake, food intake, and body weight were monitored throughout the experiment to verify that the rats learned to drink sucrose, that they adjusted chow intake for calories consumed from sucrose (~10%), and that there was no effect on body weight gain as is normally seen with this model (Ulrich-Lai et al., 2007). Drink treatment terminated on day 14 and at 8:00 on the morning of day 15, the rats were sacrificed by rapid decapitation. BLA tissue was dissected, RNA extracted, and gene expression changes between water and sucrose groups were accessed by microarray. We used microarray to assess the changes in gene expression in the BLA of rats that have had a history of sucrose snacks (n=12) vs control (n=12). Rats received access (up to 4 mL) to extra bottles containing water (control) or 30% sucrose twice daily for 14 days. Rats had ab lib access to chow and water for the duration of the experiment. Rats were sacrificed the morning of day 15 and the BLA was removed for microarray analysis. Functional cluster analysis was performed on the list of 145 significantly upregulated genes using Ingenuity Pathway Analysis (Ingenuity Systems, Redwood City, CA). See supplementary file at the foot of this record.

Project description:A summary of the work associated to these microarrays is the following: Background: Phenolic compounds present in coffee are antioxidants in vitro that might protect against cardiovascular disease and certain types of cancer in humans. Objective: Our aim was to identify differentially expressed genes upon incubation of HT-29 human colon cancer cells with instant caffeinated coffee (ICC) or caffeic acid (CA) using microarrays. Results: In HT-29 cells incubated with ICC, 77 genes were overexpressed whereas 162 were underexpressed. Upon incubation with CA, 12 genes were overexpressed whereas 33 were underexpressed. A list of five overexpressed genes and eleven underexpressed genes were found in common between the two conditions and was use to construct a biological association network. In the generated network, STAT5B and ATF-2 appeared as highly interconnected nodes. STAT5B overexpression was confirmed at the mRNA and protein levels. For ATF-2, the changes in mRNA levels were confirmed for both ICC and CA, whereas the decrease in protein levels was only observed in CA-treated cells. The levels of cyclin D1, a target gene for both STAT5B and ATF-2 transcription factors, decreased dramatically in breast cancer cells treated with CA or ICC. Conclusions: Coffee polyphenols are able to affect gene expression in cancer cells through the modulation of STA5B and ATF-2 transcription factors. The aim of our study was to evaluate, by using whole genome microarrays, the effects of one cup of coffee, either regular caffeinated coffee or a coffee polyphenol, such as caffeic acid, on HT-29 gene expression, Three experimental approaches were conducted to assess the effects of coffee on HT29 cells. I) Incubation with non cytotoxic concentrations of ICC (7 Âµg/mL) for 24h. (Group ICC); II) Incubation with non cytotoxic concentrations of CA (1.68 Âµg/mL) for 24h. (Group CA); III) non treatment of HT-29 to refered as a control (Group CNT). Triplicate samples were hybridized for each experimental condition (9 samples in total). The samples provided were analyzed using the specific software GeneSpring GX.

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A clinical trial to study the effects of coffee and chewing gum on return of normal bowel function after undergoing surgery for malignant tumors of female reproductive system.

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