Active clinical trials for "Cachexia"

This study is the first administration of GSK2849466 in humans. This will be a single centre, randomized, double-blind, placebo-controlled study, to investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GSK2849466, given as single and repeat oral doses up to 14 days to healthy male subjects. Part A will be a randomized placebo controlled and 4-way crossover study. It will include two cohorts of 8 subjects each. In each cohort there will be 4 study periods each approximately of 1 week including 6 days of washout. Each subject will receive a total of 3 active doses as ascending single oral dose of GSK2849466 and 1 placebo dose during the course of their participation in the study. The first ("bridging dose") dose provided to subjects in Cohort 2 will be the same as the last dose provided to subjects in Cohort 1. The single doses of GSK2849466 planned in Part A of this study are: 0.01, 0.03, 0.1, and 0.3 milligram (mg) in Cohort 1 and 0.3, 1, 3, and 10 mg in Cohort 2. In cohorts 1 and 2 all available safety, tolerability, and PK data will be reviewed prior to each dose escalation. The dosing schedule in Part A may be adjusted to expand a cohort or to add an additional cohort(s) in order to further evaluate additional doses or repeat evaluation of a dose level already studied. Part B will be a randomized placebo controlled, parallel group study. It will include three cohorts of 12 subjects each. Each subject will receive repeat doses of GSK2849466 over 14 days. The doses chosen for Part B will be based on the safety, tolerability, and PK data from Part A. Subjects in Cohort 4 (and/or an another cohort [s] as determined based on Part A PK data) will be dosed in the fasted state on Days 1 and 14 and in the fed state on Day 7 when subjects will receive a standard meal 30 minutes prior to dosing. Part B will provide sufficient safety and tolerability data to bridge to longer duration studies. The study duration, including screening and follow-up, is not expected to exceed 70 days for subjects in the study.

Cancer cachexia is a complex metabolic process affecting up to 80% of patients suffering from an advanced-stage cancer. Moreover, 20 to 40% of all cancer deaths are caused directly by cachexia. Head and neck (H&N) cancer patients are nutritionally vulnerable since tumour localisation can interfere with food intake, since alcohol and tobacco abuse - two etiological risk factors of H&N cancer - are associated with nutritional deficits, and since the intensive treatment can lead to progressive weight loss. Recently, omega-3 fatty acids have gained interest for their beneficial effects in several diseases. Moreover, nutritional supplementation enriched with omega-3 FA could potentially maintain body weight in cancer patients undergoing intensive treatment. Aims In this study, the investigators want to evaluate the use of omega-3 FA supplementation as nutritional and the investigators would like to identify potential risk factors, biomarkers and objective measurement tools which can predict therapy-induced cachexia.

The goal of the investigators study is to investigate the role of a hormone named Activin A (ActA) in the development of the skeletal muscle atrophy caused by cancer. According to the investigators hypothesis, ActA could be released by the tumor and activate a muscle atrophy gene program. To answer this question, the investigators plan first to compare circulating levels of ActA in cancer patients with and without cachexia. In a second step, the investigators would like to assess whether ActA circulating levels are predictive for the development of cachexia and short survival.

The purpose of this study is to assess if Gtx-024 is effective in increasing lean body mass in subjects with muscle wasting related to cancer.

RATIONALE: Etanercept is a substance that is being studied as a treatment for cachexia (weight loss) and anorexia (lack of appetite) in patients who have cancer. It is not yet known whether etanercept is effective in improving cancer-related cachexia and anorexia. PURPOSE: Randomized phase III trial to determine the effectiveness of etanercept in treating cancer-related cachexia and anorexia in patients who have advanced cancer.

RATIONALE: Megestrol helps improve appetite. It is not yet known if megestrol is effective in limiting weight loss in patients who are undergoing radiation therapy. PURPOSE: Randomized phase III trial to determine the effectiveness of megestrol in limiting weight loss in patients who are undergoing radiation therapy for lung cancer.

Cancer cachexia is responsible for the death of approximately 20% of patients. Myostatin is a master negative regulator of skeletal muscle mass. If the role of myostatin in cancer cachexia is now well established in murine models, no study has focused on muscle expression of Myostatin in relation to the degree of cachexia. the hypothesize is that muscle Myostatin a biological marker of cachexia in patients with cancer of digestive system. The main objective is to compare skeletal muscle Myostatin messenger RiboNucleic Acid (mRNA) level as a function of cachexia in cancer of digestive system patients. Myostatin messenger RiboNucleic Acid (mRNA) level will be determined in a muscle sample taken during the resection under general anaesthesia. Skeletal muscle index will be determined before surgery, 3 and 6 months after surgery. Muscle strength of the lower and upper limbs will be determined before resection, at 1 month, 3 months and 6 months postoperatively. Blood sampling will also be performed on these 4 occasions.

The purpose of this study is to determine whether skeletal muscle mitochondrial function is altered in patients with head and neck cancer compared to healthy controls.

The prevalence of malnutrition is overwhelming in pancreatic cancer patients, >80% experience a weight loss >10% of their habitual weight, which may develop into cancer cachexia. Cachexia may cause decreased quality of life, increased mortality and morbidity e.g. poorer response to antitumor treatment, longer length of stay, higher complications rate and shorter life expectancy. There is currently no effective treatment of cancer cachexia, but clinical research in medical cannabis show promising results. The cannabinoids THC and CBD show the highest pharmacological effect, but cannabis consists of >70 cannabinoids. THC and CBD exert their effect on the endocannabinoid system which modulate physiological systems such as pain, inflammation, appetite and energy balance. Thus, this potential orexigenic effect from THC and CBD may improve the nutritional state in patients with pancreatic cancer. Taking the above scientific rationale and the lack of evidence into account, the relevance of this clinical trial appears high. This clinical trial is an eight-week crossover design examining the effects of the cannabinoids THC and CBD on energy- and protein intake and lean body mass as a measure of appetite, nausea and quality of life. A characterization of the metabolism is analysed through a metabolomics analysis.

Global acute malnutrition (GAM) in children under five is defined by being too thin for a given height and/or having the Mid-upper arm circumference less than a given threshold. GAM includes moderate acute malnutrition (MAM) and severe acute malnutrition (SAM). This study has been designed to generate new evidence about the simplified combined protocol for the identification and treatment of GAM in Venezuela. The objective of the study is to document the safety and effectiveness of the Venezuelan simplified treatment protocol for GAM, which includes reduced frequency of follow-up visits, single product use and optimized daily RUTF dose. This prospective longitudinal study was conducted in 19 centers treating GAM in children aged 6-59 months diagnosed with uncomplicated GAM, defined as WHZ <-2 or MUAC <125mm or ++ bilateral edema. Children will be prospectively followed for a total of 6 months, including the treatment phase and the immediate post-discharge weeks until 6 months. The effectiveness of the treatment will be measured by the recovery rate, duration of the treatment and changes in anthropometry (weight, height and arm circumference). Other treatment effects will also be measured, including how many are admitted to the hospital, death and relapse rates from the nutritional program. An economic evaluation component will be incorporated. Total costs will be aggregated and presented as costs per child treated and per child recovered.