Status:
UNKNOWN
Effect of Multi-modal Intervention Care on Cachexia in Patients With Advanced Cancer Compared to Conventional Management (MIRACLE)
Lead Sponsor:
Kil Yeon Lee
Collaborating Sponsors:
National Research Foundation of Korea
Conditions:
Gastric Cancer
Colorectal Cancer
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief Summary
Background Cancer Cachexia (CC) is a multi-factorial process characterized by progressive weight loss, muscle mass and fat tissue wasting, and adversely affecting their quality of life and survival i...
Detailed Description
\[PICOT\] Population: Patients with recurrent or metastatic solid cancer (gastric, colorectal, pancreas, biliary tract and lung) Intervention: Multimodal treatment Comparison: Conventional palliativ...
Eligibility Criteria
Inclusion
- Patients over 19 years of age
- Patients diagnosed with gastrointestinal (stomach, esophageal, direct colon, liver, pancreatic biliary tract) cancer and lung cancer
- Patients receiving first- or second-line palliative chemotherapy
- ECOG PS 0-2
- Patients who were classified as normal, precachexia or cachexia according to the cachexia classification criteria
- Normal: Neither pre-cachexia Nor cachexia
- Precachexia: Weight loss ≤5%, Anorexia or glucose intolerance in last 6 months
- Cachexia: Weight loss \>5%, or BMI \<20 with weight loss \>2% in last 6 months
- Adequate organ functions
Exclusion
- Patients with history of heart failure or currently being treated for heart failure
- Patients with SBP of 160 mmHg or higher or DBP of 100 mmHg or higher despite antihypertensive medication
- Patients with or have a history of bronchial asthma
- Patients with bowel obstruction
- Patients who have taken appetite stimulants or anabolic or anti-catabolic agents (eg. Megestrol acetate, progestational agents, etc.) within 30 days prior to the study enrollment
- Patients who received steroid treatment (\> 10 mg/d prednisolone or equivalent) within 3 months prior to the study enrollment
- Patients who have taken nonsteroidal anti-inflammatory drugs or aspirin continuously for more than 1 week
- Patients with problems with taking non-steroidal anti-inflammatory drugs (NSAIDs) or those with uncontrolled diabetes due to digestive system diseases (gastric ulcer, gastrointestinal bleeding, etc.)
- Patients who are pregnant or breastfeeding, who have not used proper contraception (oral, injection, infusion or hormonal contraceptive methods, intrauterine devices and blocking methods)
- Patients who are taking anticoagulants (e.g. warfarin or heparin)
- Patients who have difficulty in oral administration
- Patients who have a history of hypersensitivity reactions such as asthma, hives, or allergic reactions to drugs containing ibuprofen, aspirin, and other nonsteroidal anti-inflammatory drugs (including COX-2 inhibitors)
- Patients who showed clinically significant hypersensitivity reactions to investigational products
Key Trial Info
Start Date :
January 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2022
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT04907864
Start Date
January 31 2020
End Date
June 30 2022
Last Update
June 1 2021
Active Locations (1)
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1
Kyung Hee University Hospital
Seoul, South Korea, 02447