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The Effect of LentinexHP on Quality of Life in Stage IV Colorectal Cancer

ABSTRACT: This is a randomized, double-blind parallel-group, placebo-controlled study. that will last 40 weeks and will focus on Quality of Life.36 Subjects with stage IV metastatic colorectal cancer will be referred for study inclusion. Patients will be randomly assigned (1:1 ratio) to take 2 ml of LentinexHP or placebo orally twice a day (a total of 6 mg). Products will be dispensed to allow administration of the product for six weeks. Each bottle of LentinexHP or placebo contains 30 mL, which at 1.5 mg/mL will provide dosage for approximately five days. The patients will periodically complete the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Quality of Life (QoL) instrument, the short form 36 (SF-36), the Fatigue Symptom Inventory (FSI), and the QoL questionnaire used in the previous LentinexHP QoL study.

DISEASE(S): Change In Mood,Change In Personality

PROVIDER: 67164 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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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

Project description:The purpose of this study is to learn about Health-related Quality Of Life (HRQoL) in patients enrolled in the Rare Kidney Stone Consortium (RKSC) registries. Quality of life studies look at different aspects of both physical and mental components of people's lives. HRQoL data for people affected by kidney stones are not currently available for people followed over time. All participants enrolled in the RKSC registries will be invited, via email or postal mail, to participate in this study. Health-related quality of life in people with rare kidney stones enrolled in the RKSC registries will be measured. Instruments used in this study are the SF-10 for pediatric participants and SF-36v2 for adult participants. The surveys will be completed online. Participants without a computer or internet access will participate using a paper version of the survey. These surveys will be done at enrollment and annually thereafter. The SF-36v2 includes 36 questions and is estimated to take 15 minutes for its completion, while the SF-10 includes 10 questions and could be completed in 5 minutes. The research questions are: <OL> <Li> Assessment of HRQoL in patients with rare kidney stones. Comparison of HRQoL results between rare kidney stone formers, general population and other populations with relevant chronic diseases.</Li> <Li> Comparison of HRQoL results in the same populations affected by different stones and analyzed with attention to the effects of various factors included in the disease registry, such as stone activity, burden of urologic interventions, medication and other treatments.</Li> <Li> Evaluation of HRQoL and its trends over time in patients undergoing treatment for rare kidney stones.</Li> </OL> About this study: The plan is to have 400 participants from all four registries take part in this multi-center study. The assessment of your HRQoL will be done annually for 5 years.

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The Effect of LentinexHP on Quality of Life in Stage IV Colorectal Cancer

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