Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Multi-modal Intervention Care on Cachexia in Patients With Advanced Cancer Compared to Conventional Management (MIRACLE) (MIRACLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04907864
Recruitment Status : Recruiting
First Posted : June 1, 2021
Last Update Posted : June 1, 2021
Sponsor:
Collaborator:
National Research Foundation of Korea
Information provided by (Responsible Party):
Kil Yeon Lee, Kyunghee University Medical Center

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.


Condition or disease Intervention/treatment Phase
Gastric Cancer Colorectal Cancer Pancreatic Cancer Biliary Tract Cancer Lung Cancer Precachexia Cachexia Combination Product: Multi-modal intervention Phase 2

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: An open-label, randomized phase 2 trial
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : January 31, 2020
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : June 30, 2022


Arm Intervention/treatment
Experimental: MIC
Multi-modal intervention
Combination Product: 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 Names:
  • ibuprofen (Brufen)
  • omega-3-fattyacid (Omacor)
  • Bojungikki-tang (Kracie Bojungikgitang Extract Fine Granule)
  • oral nutritionalsupplement (HARMONILAN SOLN)

No Intervention: CPC
Conventional Palliative Care



Primary Outcome Measures :
  1. Median change (kilogram, kg) in total lean body mass (LBM) [ Time Frame: Change of value between baseline and week13 ]
    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)

  2. Median change (kg) in handgrip strength [ Time Frame: Change of value between baseline and week13 ]
    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 :
  1. Median change (kg) in fat mass [ Time Frame: Change of value between baseline and week13 ]
    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)

  2. Median change (kg) in total body mass [ Time Frame: Change of value between baseline and week13 ]
    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)

  3. Median change (kg) in body weight (kg) [ Time Frame: Change of value between baseline and week13 ]
    The average of the change (kg) from baseline at week 7 and change from baseline at week 13 measured by the calibrated scale

  4. Median change (kg) in lean body mass of trunk [ Time Frame: Change of value between baseline and week13 ]
    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)

  5. Median change (kg) in lean body mass of both upper and lower extremities [ Time Frame: Change of value between baseline and week13 ]
    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)

  6. Change from Anorexia-Cachexia scale [ Time Frame: Change of value between baseline and week 13 ]
    Functional Assessment of Anorexia/Cachexia Treatment (FAACT) version 4, The higher the score, the better the quality of life (QoL) with range 0-156.

  7. Change in quality of life (QoL) [ Time Frame: Change of value between baseline and week 13 ]

    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.


  8. Rate of toxicity with clinical significance, and possible relationship to either study intervention [ Time Frame: Change of value between baseline and week 13 ]
    Assessed by the investigator, based on toxicity grade (according to the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v5.0)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04907864


Contacts
Layout table for location contacts
Contact: Chi Hoon Maeng, M.D. +82-2-958-2965 mchihoon@khu.ac.kr
Contact: Bo-Hyung Kim, M.D. +82-2-958-9326 bhkim98@khu.ac.kr

Locations
Layout table for location information
Korea, Republic of
Kyung Hee University Hospital Recruiting
Seoul, Korea, Republic of, 02447
Contact: Chi Hoon Maeng, M.D.    +82-2-958-2965    mchihoon@khu.ac.kr   
Contact: Bo-Hyung Kim, M.D.    +82-2-958-9326    bhkim98@khu.ac.kr   
Sponsors and Collaborators
Kil Yeon Lee
National Research Foundation of Korea
Investigators
Layout table for investigator information
Principal Investigator: Kil Yeon Lee, M.D. Kyung Hee University Hospital
Layout table for additonal information
Responsible Party: Kil Yeon Lee, Professor, Kyunghee University Medical Center
ClinicalTrials.gov Identifier: NCT04907864    
Other Study ID Numbers: KHMC-HUMANITAS-01
First Posted: June 1, 2021    Key Record Dates
Last Update Posted: June 1, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After anonymizing the patient's confidential information, it can be converted into data and shared.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kil Yeon Lee, Kyunghee University Medical Center:
cachexia
chemotherapy
cancer
multi-modal intervention
NSAID
Additional relevant MeSH terms:
Layout table for MeSH terms
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Wasting Syndrome
Cachexia
Digestive System Diseases
Biliary Tract Diseases
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Metabolic Diseases
Nutrition Disorders
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action