None listed
Conditions
Interventions
Drug, Behavioral, Dietary Supplement : Patients will be allocated to Multi-modal Intervention Care (MIC) or Conventional Palliative Care (CPC).
The MIC consists of Ibuprofen (non-steroidal anti-inflam
Sponsors
Kyung Hee University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in total lean body mass;Change in handgrip strength | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of change from baseline over 12 weeks in total lean body mass and handgrip strength;Change/Rate of change from baseline over 12 weeks in fat mass, total body mass and weight;Change/Rate of change from baseline over 12 weeks in trunk lean body mass and both extremities lean body mass;Change/Rate of change from baseline over 12 weeks in anorexia-cachexia scale;Change/Rate of change from baseline over 12 weeks in European Orgaization for Research and Treatment of Cancer - Quality of life Questionnaire Core 30 (EORTC-QLQ C30);Change/Rate of change from baseline over 12 weeks in Spleen Qi deficiency questionnaire score (SQDQ);Overall survival rate | — |
Countries
Korea, Republic of
Contacts
Public ContactSAEBYUL YOO
Kyung Hee University Hospital
Outcome results
None listed