Effect of multi-modal intervention care on cachexia in patients with advanced cancer compared to conventional management
- Conditions
- Neoplasms
- Registration Number
- KCT0004967
- Lead Sponsor
- Kyung Hee University Hospital
- Brief Summary
[Objective] The aim of this study is to discover Korean medicine formulations that can improve cancerous cachexia and to demonstrate the prevention and treatment effects of cancerous cachexia by reprogramming/activating muscle stem cells and mesenchymal stem cells (fat and bone marrow) by Korean medicine formulations in preclinical trials. [Contents] 1. Preclinical verification of prevention and treatment efficacy of cancerous cachexia by reprogramming/activation of stem cells by herbal medicines and identification of mechanisms 2. Preclinical verification and mechanism identification of prevention and treatment efficacy of cancerous cachexia through inhibition of muscle and adipose tissue loss by Korean medicine preparations 3. Develop a screening tool to predict the development of cachexia in cancer patients 4. Phase II clinical study to validate the therapeutic and palliative effects of Korean medicine formulas in the pre-cachexia stage and cachexia. 5. Establishment and realization of an integrated care system for effective prediction of patients at risk of cachexia and management of patients with cachexia through a western multidisciplinary approach, based on the cachexia screening tool and clinically validated Korean medicine formulations 6. establishment of a medical app that can be used by patients in actual clinical practice and a website that utilizes clinical data from cachexia-related researchers [Expected outcomes] 1. develop new integrated treatment targets and technologies for the treatment of cancerous cachexia 2. Utilize integrated treatment technologies to prevent and improve cachexia associated with various chronic diseases 3. Develop cellular therapeutics for the prevention and amelioration of cachexia 4. Develop therapeutic agents for the treatment of sarcopenia 5. Develop a cachexia early screening tool and a cachexia care system that integrates it 6. Contributing to the development of the medical industry in the era of the Fourth Industrial Revolution through the development of an integrated management system app for Western and Oriental medicine 7. Establishment of a new market for cancerous cachexia treatment using oriental medicine technology
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 67
1) Patients diagnosed with gastrointestinal cancer (stomach, esophagus, colorectum, liver, pancreatic biliary tract) or lung cancer
2) Unresectable and/or metastatic cancer
3) Patients who receive a first-line or second-line cancer chemotherapy. Patients who are treated with concurrent chemoradiotherapy are also eligible, however those who receive radiotherapy only are not eligible.
4) Patients who completed a baseline evaluation within a week prior to start of chemotherapy.
5) 19 years of age and older
6) Written informed consent
7) In the opinion of the Investigator, able to comply with the study procedures (e.g., patients without limitation of simple exercise, intake of nutritional supplement, ibuprofen, and omacor)
8) ECOG performance status 0-2
9) Patients with normal, precachexia or cachexia by the following criteria
• Normal: without precachexia and cachexia
• Precachexia: weight loss of = 5% within the previous 6 months and experience of anorexia or metabolic symptoms such as glucose intolerance
• Cachexia: weight loss of > 5% within the previous 6 months, or BMI < 20 kg/m and weight loss of > 2%
10) Patients who showed the laboratory results as the following, within 7 days prior to first administration of chemotherapy. When results reported over 7 days prior to the start chemotherapy, patients have to retest and reconfirm for the following criteria.
• White blood cells = 3,000/mm3 and neutrophils = 1,200/mm3
• Platelets = 100,000/mm3
• Hemoglobin = 8 g/dL
• AST and ALT = 3.0 x upper limit of normal (AST and ALT = 5.0 x upper limit of normal in patients with liver metastases)
• Total bilirubin = 2.0 x upper limit of normal
• Creatinine = 1.5 x upper limit of normal or creatinine clearance (measured value or calculated value by Cockcroft/Gault equation) = 60mL/min
1) Patients with the disease or history as the following
• Confirmed history of heart failure, or receiving treatment for heart failure
• SBP=160 mmHg or DBP=100 mmHg despite of antihypertensive treatment
• Asthma or history of asthma
• Occurring pain before/after coronary artery bypass
• Congenital disorders of amino acid metabolism
• Signs or symptoms of intestinal obstruction
• Gastrointestinal Impairment
• Acute phase of short bowel syndrome or inflammatory bowel disease(ulcerative colitis, Crohn's disease)
• Receiving high dose methotrexate as chemotherapy
• Taking preoperative nutritional care, as colorectal cancer
• Hepatic encephalopathy or apprehensive of hepatic encephalopathy
• Inherited problem such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption or etc.
• Sensitivity or history of allergic to milk
2) Use of appetite stimulant, anabolic or catabolic agents (e.g., Megestrol acetate, progestational agents etc.) within 30 days prior to the date of randomization
3) Had steroid therapy (> 10 mg/d prednisolone or equivalent) within 3 months prior to enrollment (in case of inhaled, optical or pulsed oral steroid, within 10 days prior to enrollment)
4) Taking non-steroidal anti-inflammatory drugs or aspirin over 1 week
5) Inability to readily taking non-steroidal anti-inflammatory with gastrointestinal disease, or uncontrolled diabetes mellitus
6) Women who are pregnant or breast-feeding, refuse to use accepted methods of contraception (oral contraceptive, contraceptive injection, hormonal or non-hormonal contraceptive implant, intrauterine device and intrauterine contraceptive device)
7) Currently taking anticoagulant drugs (e.g., warfarin, heparin)
8) Inability to readily swallow oral formulation
9) History of clinically significant hypersensitivity like asthma, urticarial, and allergic reaction to any Ibuprofen’s compound, aspirin and any non-steroidal anti-inflammatory drugs (including COX-2 inhibitors)
10) Clinically significant hypersensitivity to any Omacor’s compound
11) Clinically significant hypersensitivity to any Kracie bojungikki-tang ext. fine granule’s compound
12) Clinically significant hypersensitivity to any Harmonilan’s compound
13) Clinically significant hypersensitivity to any megestrol acetate’s compound
14) Subjects judged to be inappropriate to participate and perform this clinical trial at the discretion of investigators.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method