Effect of Multi-modal Intervention Care on Cachexia in Patients With Advanced Cancer Compared to Conventional Management (MIRACLE)
MIRACLE
1 other identifier
interventional
112
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 gastric-cancer
Started Jan 2020
Shorter than P25 for phase_2 gastric-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 31, 2020
CompletedFirst Submitted
Initial submission to the registry
May 25, 2021
CompletedFirst Posted
Study publicly available on registry
June 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedJune 1, 2021
May 1, 2021
2.2 years
May 25, 2021
May 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Median change (kilogram, kg) in total lean body mass (LBM)
The average of the change (kg) from baseline at week 7 and change from baseline at week 13 measured by DEXA (dual-energy X-ray absorptiometry)
Change of value between baseline and week13
Median change (kg) in handgrip strength
The average of the change (kg) from baseline at week 7 and change from baseline at week 13 measured by DEXA (dual-energy X-ray absorptiometry)
Change of value between baseline and week13
Secondary Outcomes (8)
Median change (kg) in fat mass
Change of value between baseline and week13
Median change (kg) in total body mass
Change of value between baseline and week13
Median change (kg) in body weight (kg)
Change of value between baseline and week13
Median change (kg) in lean body mass of trunk
Change of value between baseline and week13
Median change (kg) in lean body mass of both upper and lower extremities
Change of value between baseline and week13
- +3 more secondary outcomes
Study Arms (2)
MIC
EXPERIMENTALMulti-modal intervention
CPC
NO INTERVENTIONConventional Palliative Care
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kil Yeon Leelead
- National Research Foundation of Koreacollaborator
Study Sites (1)
Kyung Hee University Hospital
Seoul, 02447, South Korea
Related Publications (1)
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.
PMID: 35410294DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kil Yeon Lee, M.D.
Kyung Hee University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 25, 2021
First Posted
June 1, 2021
Study Start
January 31, 2020
Primary Completion
March 31, 2022
Study Completion
June 30, 2022
Last Updated
June 1, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
After anonymizing the patient's confidential information, it can be converted into data and shared.