Back to resultsEffect of Multi-modal Intervention Care on Cachexia in Patients With Advanced Cancer Compared to Conventional Management (MIRACLE) (MIRACLE)
Primary Purpose
Gastric Cancer, Colorectal Cancer, Pancreatic Cancer
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Multi-modal intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Gastric Cancer focused on measuring cachexia, chemotherapy, cancer, multi-modal intervention, NSAID
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Kyung Hee University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
MIC
CPC
Arm Description
Multi-modal intervention
Conventional Palliative Care
Outcomes
Primary Outcome Measures
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)
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)
Secondary Outcome Measures
Median change (kg) in fat mass
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)
Median change (kg) in total body mass
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)
Median change (kg) in body weight (kg)
The average of the change (kg) from baseline at week 7 and change from baseline at week 13 measured by the calibrated scale
Median change (kg) in lean body mass of trunk
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)
Median change (kg) in lean body mass of both upper and lower extremities
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 from Anorexia-Cachexia scale
Functional Assessment of Anorexia/Cachexia Treatment (FAACT) version 4, The higher the score, the better the quality of life (QoL) with range 0-156.
Change in quality of life (QoL)
The EORTC QLQ-C30 (Version 3) uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome.
The EORTC QLQ-C30 (Version 3) uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. First of all, raw score has to be calculated with mean values. Afterwards linear transformation is performed to be comparable. More points are considered to have a better outcome.
Rate of toxicity with clinical significance, and possible relationship to either study intervention
Assessed by the investigator, based on toxicity grade (according to the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v5.0)
Full Information
NCT ID
NCT04907864
First Posted
May 25, 2021
Last Updated
May 28, 2021
Sponsor
Kil Yeon Lee
Collaborators
National Research Foundation of Korea
1. Study Identification
Unique Protocol Identification Number
NCT04907864
Brief Title
Effect of Multi-modal Intervention Care on Cachexia in Patients With Advanced Cancer Compared to Conventional Management (MIRACLE)
Acronym
MIRACLE
Official Title
Effect of Multi-modal Intervention Care on Cachexia in Patients With Advanced Cancer Compared to Conventional Management (MIRACLE): An Open-label, Phase 2 Tria
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 31, 2020 (Actual)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kil Yeon Lee
Collaborators
National Research Foundation of Korea
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
[PICOT] Population: Patients with recurrent or metastatic solid cancer (gastric, colorectal, pancreas, biliary tract and lung)
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Colorectal Cancer, Pancreatic Cancer, Biliary Tract Cancer, Lung Cancer, Precachexia, Cachexia
Keywords
cachexia, chemotherapy, cancer, multi-modal intervention, NSAID
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
An open-label, randomized phase 2 trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MIC
Arm Type
Experimental
Arm Description
Multi-modal intervention
Arm Title
CPC
Arm Type
No Intervention
Arm Description
Conventional Palliative Care
Intervention Type
Combination Product
Intervention Name(s)
Multi-modal intervention
Other Intervention Name(s)
ibuprofen (Brufen), omega-3-fattyacid (Omacor), Bojungikki-tang (Kracie Bojungikgitang Extract Fine Granule), oral nutritionalsupplement (HARMONILAN SOLN)
Intervention Description
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
Primary Outcome Measure Information:
Title
Median change (kilogram, kg) in total lean body mass (LBM)
Description
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)
Time Frame
Change of value between baseline and week13
Title
Median change (kg) in handgrip strength
Description
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)
Time Frame
Change of value between baseline and week13
Secondary Outcome Measure Information:
Title
Median change (kg) in fat mass
Description
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)
Time Frame
Change of value between baseline and week13
Title
Median change (kg) in total body mass
Description
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)
Time Frame
Change of value between baseline and week13
Title
Median change (kg) in body weight (kg)
Description
The average of the change (kg) from baseline at week 7 and change from baseline at week 13 measured by the calibrated scale
Time Frame
Change of value between baseline and week13
Title
Median change (kg) in lean body mass of trunk
Description
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)
Time Frame
Change of value between baseline and week13
Title
Median change (kg) in lean body mass of both upper and lower extremities
Description
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)
Time Frame
Change of value between baseline and week13
Title
Change from Anorexia-Cachexia scale
Description
Functional Assessment of Anorexia/Cachexia Treatment (FAACT) version 4, The higher the score, the better the quality of life (QoL) with range 0-156.
Time Frame
Change of value between baseline and week 13
Title
Change in quality of life (QoL)
Description
The EORTC QLQ-C30 (Version 3) uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome.
The EORTC QLQ-C30 (Version 3) uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. First of all, raw score has to be calculated with mean values. Afterwards linear transformation is performed to be comparable. More points are considered to have a better outcome.
Time Frame
Change of value between baseline and week 13
Title
Rate of toxicity with clinical significance, and possible relationship to either study intervention
Description
Assessed by the investigator, based on toxicity grade (according to the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v5.0)
Time Frame
Change of value between baseline and week 13
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chi Hoon Maeng, M.D.
Phone
+82-2-958-2965
Email
mchihoon@khu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Bo-Hyung Kim, M.D.
Phone
+82-2-958-9326
Email
bhkim98@khu.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kil Yeon Lee, M.D.
Organizational Affiliation
Kyung Hee University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyung Hee University Hospital
City
Seoul
ZIP/Postal Code
02447
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chi Hoon Maeng, M.D.
Phone
+82-2-958-2965
Email
mchihoon@khu.ac.kr
First Name & Middle Initial & Last Name & Degree
Bo-Hyung Kim, M.D.
Phone
+82-2-958-9326
Email
bhkim98@khu.ac.kr
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
After anonymizing the patient's confidential information, it can be converted into data and shared.
Citations:
PubMed Identifier
35410294
Citation
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.
Results Reference
derived
Learn more about this trial
Effect of Multi-modal Intervention Care on Cachexia in Patients With Advanced Cancer Compared to Conventional Management (MIRACLE)
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