Effect of Multi-modal Intervention Care on Cachexia in Patients With Advanced Cancer Compared to Conventional Management (MIRACLE)
NCT ID: NCT04907864
Last Updated: 2021-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
112 participants
INTERVENTIONAL
2020-01-31
2022-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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 in patients with advanced stage of cancer.
Megestrol acetate (MA), which can help maintain body weight in advanced cancer patients, has not been proven to be effective in improving quality of life or lean body mass. Furthermore, its use is often limited due to various adverse event such as Cushing syndrome, adrenal insufficiency, or thromboembolic risk.
CC has a complex and multi-factorial pathophysiology, and there is no established standard treatment.
Hypothesis CC is irreversible once it occurs and is also difficult to suppress its progression with any single treatment modality.
The investigators hypothesized that a multi-modal intervention comprised of anti-inflammation, omega-3-fatty acids, oral nutritional supplement with counselling by nutritionist, physical exercise, psychiatric intervention as well as Bojungikki-tang which mediates immune-modulation and reverse both of chronic inflammation and wasting condition as a complementary and alternative medicine (CAM) could prevent the development of CC or improve the CC in advanced cancer patients during chemotherapy compared to those who received usual supportive.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Megestrol Acetate in Improving Neoadjuvant Chemotherapy-Related Weight Loss in Locally Advanced CRC
NCT06998758
Body Composition Manipulation in CoLorectal cancEr (BiCyCLE): Neuromuscular Electrical Stimulation (NMES)
NCT04065984
An Evaluation of NGM120 in a Randomized, Double-blind, Placebo-controlled Study in Participants With Colorectal Cancer Who Have Cancer Cachexia.
NCT07033026
A Combination Therapy Including Anti-PD-1 Immunotherapy in MSS Rectal Cancer With Resectable Distal Metastasis
NCT05359393
The Effect of Cancer Therapies and Exercise on Mitochondrial Energetics and Fitness
NCT01859442
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Intervention: Multimodal treatment
Comparison: Conventional palliative care
Outcome: Change of total lean body mass, Change of handgrip strength Time: 12 weeks of study period for each subject during the first- or second-line palliative chemotherapy
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MIC
Multi-modal intervention
Multi-modal intervention
Daily oral medications: ibuprofen 400 mg three times a day, omega-3-fatty acid 1 g twice a day, Bojungikki-tang 3.75g twice a day, oral nutritional supplement (HAMONILAN SOLN) 200 ml twice a day Weekly physical exercise by physiatrist (60 minutes per visit) Biweekly psychiatric intervention Nutritional counselling total four times during the study period
CPC
Conventional Palliative Care
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Multi-modal intervention
Daily oral medications: ibuprofen 400 mg three times a day, omega-3-fatty acid 1 g twice a day, Bojungikki-tang 3.75g twice a day, oral nutritional supplement (HAMONILAN SOLN) 200 ml twice a day Weekly physical exercise by physiatrist (60 minutes per visit) Biweekly psychiatric intervention Nutritional counselling total four times during the study period
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 Criteria
* 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
19 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Research Foundation of Korea
OTHER
Kil Yeon Lee
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Kil Yeon Lee
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kil Yeon Lee, M.D.
Role: PRINCIPAL_INVESTIGATOR
Kyung Hee University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kyung Hee University Hospital
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Maeng CH, Kim BH, Chon J, Kang WS, Kang K, Woo M, Hong IK, Lee J, Lee KY. Effect of multimodal intervention care on cachexia in patients with advanced cancer compared to conventional management (MIRACLE): an open-label, parallel, randomized, phase 2 trial. Trials. 2022 Apr 11;23(1):281. doi: 10.1186/s13063-022-06221-z.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KHMC-HUMANITAS-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.