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Gastric CancerPhase 2MIRACLENCT04907864

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

A Phase 2 study testing Multi-modal intervention in people with Gastric Cancer and Colorectal Cancer, run by Kil Yeon Lee at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Multi-modal intervention
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
1 siteSouth Korea
Study dates
31 Jan 2020to 30 Jun 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Chi Hoon Maeng, M.D. contact

+82-2-958-2965

mchihoon@khu.ac.kr

Bo-Hyung Kim, M.D. contact

+82-2-958-9326

bhkim98@khu.ac.kr

South Korea1 site, 1 recruiting

  • Kyung Hee University Hospital

    Seoul, 02447

    Chi Hoon Maeng, M.D., +82-2-958-2965, mchihoon@khu.ac.kr

    Bo-Hyung Kim, M.D., +82-2-958-9326, bhkim98@khu.ac.kr

    Recruiting

Other trials in South Korea

About this study

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

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.

Read more

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.

Read the 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

Being tested
Multi-modal intervention
Keywords
cachexia, chemotherapy, cancer, multi-modal intervention, NSAID
Medical subject headings
Stomach Neoplasms, Colorectal Neoplasms, Pancreatic Neoplasms, Biliary Tract Neoplasms, Lung Neoplasms, Cachexia, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multi-modal interventionCombination product

    Also called ibuprofen (Brufen), omega-3-fattyacid (Omacor), Bojungikki-tang (Kracie Bojungikgitang Extract Fine Granule), oral nutritionalsupplement (HARMONILAN SOLN)

    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

Study groups in NCT04907864
Study groupRoleWhat they receive
MICExperimentalMulti-modal intervention
Receives: Combination Product: Multi-modal intervention
CPCNo interventionConventional Palliative Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Change of value between baseline and week13

  2. 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)

    Measured: Change of value between baseline and week13

Secondary outcomes (8)

  1. 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)

    Measured: Change of value between baseline and week13

  2. 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)

    Measured: Change of value between baseline and week13

  3. 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

    Measured: Change of value between baseline and week13

  4. 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)

    Measured: Change of value between baseline and week13

  5. 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)

    Measured: Change of value between baseline and week13

  6. 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.

    Measured: Change of value between baseline and week 13

  7. 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.

    Measured: Change of value between baseline and week 13

  8. 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)

    Measured: Change of value between baseline and week 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2021
  2. Study start31 Jan 2020
  3. Primary completion31 Mar 2022 (estimated)
  4. Study completion30 Jun 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
An open-label, randomized phase 2 trial
Masking
None (open label)
Enrolment
112 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04907864
Sponsor's protocol ID
KHMC-HUMANITAS-01
Acronym
MIRACLE
Status last verified
May 2021
First submitted
25 May 2021
Last updated
1 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: After anonymizing the patient's confidential information, it can be converted into data and shared.

Publications

  • 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.

    PubMed 35410294

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Multi-modal intervention in people with Gastric Cancer and Colorectal Cancer, run by Kil Yeon Lee at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Chi Hoon Maeng, M.D. (+82-2-958-2965, mchihoon@khu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median change (kilogram, kg) in total lean body mass (LBM) (time frame: Change of value between baseline and week13). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04907864, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2021.

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