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Cachexia clinical trials

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NCT ID: NCT04098237 Recruiting - Clinical trials for Pancreatic Adenocarcinoma

Pancreaze (Pancrelipase) for Patients With Pancreatic Adenocarcinoma With Cachexia and Exocrine Pancreatic Insufficiency

PANCAX-3
Start date: December 17, 2020
Phase: Phase 2
Study type: Interventional

The objective of this study is to assess weight stability, functional changes, and quality of life when Pancreaze (pancrelipase) delayed-release 84,000-lipase units (capsules), for main meals, and 42,000-lipase units (capsules), for snacks, are added to standard of care in patients with exocrine pancreatic insufficiency due to pancreatic adenocarcinoma. This will be the first prospective study of this particular formulation in addition to standard of care in advanced pancreatic cancer patients. We will treat 40 consecutive patients with borderline resectable, locally advanced and advanced pancreatic cancer patients who present with weight loss and exocrine pancreatic insufficiency with this advanced formulation of Pancreaze.

NCT ID: NCT04067167 Recruiting - Cancer Clinical Trials

Flexi Band Resistance Training Versus EMS Exercise in Patients With the Diagnosis of Malignant Diseases

FREEDOM
Start date: May 1, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the effects of a 12-week flexi band resistance training program compared to different whole-body electromyostimulation (WB-EMS) exercise programs on muscle strength, body composition (in particular muscle mass), cardiorespiratory fitness, inflammation, and patient-reported subjective outcomes (e.g. quality of life, fatigue, performance status) in patients with malignant disease undergoing curative or palliative anti-cancer treatment.

NCT ID: NCT04065815 Recruiting - Cancer Clinical Trials

Protein-rich Nutritional Therapy Combined With Time-efficient Exercise in Cancer Therapy

PROTECT
Start date: May 1, 2019
Phase: N/A
Study type: Interventional

This study aims to evaluate the effects of a 12-week protein-rich individualized nutritional therapy combined with different time-efficient exercise programs on overall physical fitness (cardiorespiratory fitness and muscular fitness), inflammation, and muscle mass/body composition in patients with malignant disease undergoing curative or palliative anti-cancer treatment

NCT ID: NCT03789136 Recruiting - Cachexia; Cancer Clinical Trials

The Effect of Colon Cancer on Muscle Gene Expression, Body Composition, Muscle Function, and Muscle Metabolism

COMUNEX
Start date: February 24, 2017
Phase:
Study type: Observational

Rationale: Cancer cachexia is a complex metabolic syndrome characterized by clinically relevant loss of muscle mass with or without loss of fat mass. To determine how treatment methods can be most effective, full insight in changes in gene expression, body composition, muscle function and muscle metabolism are of great importance. Objective: Main aim of the study is to investigate the differences in gene expression, body composition, muscle function and muscle metabolism in colon cancer patients compared to controls. Study design: Observational study Study population: 40 colon cancer patients undergoing a tumor resection (30 primary tumor and 10 liver metastases) and 15 control patients undergoing an inguinal hernia repair (♂, 10) or an abdominal hysterectomy (♀, 5). Main study parameters/endpoints: Primary study parameter will be gene expression (transcriptomic and polymerase chain reaction analyses of muscle biopsies). Secondary parameters will be body composition (determined in available CT scans and bio impedance analysis and with DEXA), muscle function parameters (grip and knee flexion/extension strength and measured in a biopsy), metabolic markers (measured in fat and muscle biopsies), biochemical markers (measured in blood/serum) and gene expression of fat biopsies. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The investigators expect no additional risk for the subjects due to the proposed measurements. Biopsies will be taken during the planned operation and therefore is not expected to cause a significant increase in burden for the patient. All other measurements are non-invasive, observational measurements with no risk of any harmful side effects.

NCT ID: NCT03587870 Recruiting - Clinical trials for Muscle Wasting in Critically Ill

Protein Delivery in Intermittent and Continuous Enteral Nutrition in ICU Patients

ProBoNo
Start date: March 25, 2019
Phase: N/A
Study type: Interventional

Acute skeletal muscle wasting in ICU patients is associated with functional impairment and with increased risk of death. Of what we know today, physical disability can persist up to 5 years. Adequate nutrition is the basis for an optimal recovery for ICU patients and for prevention of muscle wasting. Today, continuous feeding is still the standard enteral nutrition form for patients in the ICU to limit the incidence of aspiration. A study of Serpa et al. and Georgia et al. compared the continuous feeding versus a bolus nutrition with a feeding time of 30 - 60 minutes every 4 hours. They showed no statistical differences in complications between both groups. ProBoNo is a prospective, randomized, controlled pilot study of critically ill patients with a protein- rich formula to explore the impact of continuous or intermittent bolus nutrition on muscle breakdown in ICU patients. The investigators would like to recruit 68 patients during the first 24 hours after surgical intensive care unit admission. Prior beginning of nutrition administration, and on the 7th day thereafter the investigators will perform a muscle biopsy and an ultrasound from the vastus lateralis muscle in both groups. The primary outcome is the time from 6.00 am of the following day after admission until the patient reaches his daily protein's target quantity. Secondary outcomes include the diameter and densitiy of the hamstrings assessed by ultrasound and histology, the process of gastric residual volume, number of diarrhoea events and laboratory findings like glucose, urea and insulin like growth factor (IGF)-1, all compared between the two time points. Intermittent feeding is not only more natural and could help to limit the muscle wasting in ICU patients, it is also easier to handle for the ICU caring medical team. A trial from Georgia et al. in 2007 compared continuous to intermittent enteral nutrition. They found that the intermittently fed patients reached their nutrition goal faster than those being continuously nourished. This might in part be explained by feeding interruptions in the continuous feeding regimen. Presumably, preoperative holding of tube feedings in the continuous nutrition group most commonly caused interruptions. Thus, independently from prevention of muscle breakdown, a bolus nutrition would be more attractive.

NCT ID: NCT03570242 Recruiting - Gynecologic Cancer Clinical Trials

WB-EMS and Individualized Nutritional Support in Gynecological Cancer Patients

Start date: July 1, 2017
Phase: N/A
Study type: Interventional

This study evaluates the effects of a 12-week whole-body electromyostimulation (WB-EMS) training combined with individualized nutritional support on body composition, muscle strength and function, quality of life, fatigue and Inflammatory status on patients with gynecological cancer undergoing palliative anti-cancer Treatment. Furthermore, this study assesses the effect of this combined therapeutic approach within a 3 to 4-week pre-operative study Intervention on the period of hospitalization in gynecological patients undergoing curative anti-cancer Treatment.

NCT ID: NCT03561610 Recruiting - Cancer Clinical Trials

Novel Form of Nutritional Supplementation in Cancer Patients

Start date: May 1, 2018
Phase: N/A
Study type: Interventional

This study evaluates if a novel form of oral nutritional Supplement application in the form of gumdrops may serve as an alternative to common sip Feeds in cancer patients with high risk for malnutrition. Within this context the Impact of these two different supplements on General condition, Quality of life, muscle function, Body composition, Appetite and Nutrition Status are investigated. Patients are randomly allocated either to a study group with oral Supplementation in the form of sip feed or to a study Group receiving gumdrops for 4 weeks. After a washout period of 5-7 days study Groups are switched for another 4 week Intervention period.

NCT ID: NCT03556748 Recruiting - Cancer Clinical Trials

WB-EMS and Nutrition in Patients With Hematological Malignancies

Start date: November 1, 2017
Phase: N/A
Study type: Interventional

This study evaluates the effects of a whole-body electromyostimulation (WB-EMS) training combined with individualized nutritional support on skeletal muscle mass, body composition, muscle strength/function, quality of life, fatigue, pain and gastrointestinal symptoms in patients with hematological malignancies 4-6 weeks before and 4-6 weeks after undergoing stem cell Transplantation. Within this context, this study also investigates the effect of the nutrition and exercise intervention on the period of hospitalization, period of White blood cell recovery and frequency and severity of complications (mucositis, Graft-versus-Host-Disease, infections) after stem cell Transplantation as consequences of the therapeutic immune Suppression.

NCT ID: NCT03477721 Recruiting - Clinical trials for Cachexia; Cancer; Sarcopenia

The Role of the Muscle-nervous System Interface in Cancer Cachexia

NUMANCAN
Start date: March 16, 2018
Phase:
Study type: Observational

Sarcopenia is an important component of cachexia associated with cancer, and their high incidence in cancer patients emphasizes the need for a better understanding of its mechanisms, which can result in better therapeutic interventions to reverse this situation and improve the prognosis. Our hypothesis is that the plasma concentration of IL-6 and c-terminal agrin is directly correlated with the loss of muscle mass and development of cachexia.

NCT ID: NCT03151291 Recruiting - Cancer Clinical Trials

Effects of WB-EMS and Specific Dietary Supplements on Cancer Patients

Start date: December 2016
Phase: N/A
Study type: Interventional

Patients suffering from cancer often experience a loss of muscle mass and strength during disease and its therapy. Muscle wasting is the main characteristic of the so-called cancer cachexia syndrome and responsible for many therapy-related complications and a poorer prognosis of the patient. Stabilizing muscle mass should therefore be a great goal in cancer care. Physical exercise and nutrition are promising measures to combat cancer-related muscle atrophy but conventional exercise programs may not always be suitable for physical-weakened patients and increased catabolic processes are difficult to overcome by normal Nutrition - especially in advanced cancer. Therefore, the present study aims to test a combined approach of specific nutritional supplementation and exercise using the novel strength training method of Whole-Body electromyostimulation (WB-EMS). The study investigates the effect of a 12-week WB-EMS training combined with a dietary supplementation of β-hydroxy-β-methylbutyrate (HMB), L-carnitine (LC) or the omega-3-fatty acid eicosapentaenoic acid (EPA) on skeletal muscle mass, body composition, physical function, nutritional and inflammatory status, fatigue and quality of life in cancer patients undergoing oncological treatment. The results of this study may help to clarify the effectiveness of those combined interventions to counteract muscle wasting and other symptoms of cancer cachexia.