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A multicentric study to measure the safety and efficacy of NuvastaticÂ(Interventional drug) in reducing fatigue caused by chemotherapy in patients with metastatic colorectal cancer receiving 5-fluorouracil.

ABSTRACT: Intervention1: NuvastaticÂ 1000 mg sachet containing effervescent powder manufactured by Natureceuticals Sdn Bhd, Malaysia: 1. NuvastaticÂ is to be consumed after meal, 1 sachet Ã? 5 times a day. 2. Dissolve 1 sachet of NuvastaticÂ in 350 ml of lukewarm water and drink immediately after preparation. 3. Each sachet containing 1000 mg of standardized extract of O. stamineus Control Intervention1: Placebo sachet 1000 mg (containing all excipients except active ingredient): 1. Placebo is to be consumed after meal, 1 sachet Ã? 5 times a day. 2. Dissolve 1 sachet of Placebo in 350 ml of lukewarm water and drink immediately after preparation. Primary outcome(s): Improvement in Chemotherapy-induced fatigue as assessed by FSS (Fatigue severity scale)Timepoint: Baseline (Cycle 2), and at each cycle till 6 Cycles, EOT and Follow-up Study Design: Randomized, Parallel Group, Placebo Controlled Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Other Blinding and masking:Double Blind Double Dummy

DISEASE(S): Malignant Neoplasm Of Colon, Unspecified

PROVIDER: 2600516 | 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.

Dataset Information

A multicentric study to measure the safety and efficacy of NuvastaticÂ(Interventional drug) in reducing fatigue caused by chemotherapy in patients with metastatic colorectal cancer receiving 5-fluorouracil.

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