NCT04907864: MIRACLE

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

Status unknown Phase 2 Last updated 1 June 2021

What this trial tests

Phase 2 trial testing Multi-modal intervention in Gastric Cancer in 112 participants. Status unknown.

Timeline

31 January 2020

Primary endpoint
31 March 2022

30 June 2022

Quick facts

Lead sponsor	Kil Yeon Lee
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	112
Start date	31 January 2020
Primary completion	31 March 2022
Estimated completion	30 June 2022
Sites	1 location across South Korea

Drugs / interventions tested

• Multi-modal intervention

Conditions studied

• Gastric Cancer — all drugs for Gastric Cancer →
• Colorectal Cancer — all drugs for Colorectal Cancer →
• Pancreatic Cancer — all drugs for Pancreatic Cancer →
• Biliary Tract Cancer — all drugs for Biliary Tract Cancer →

Sponsor

Kil Yeon Lee

Who can join

19 and older, any sex, with Gastric Cancer or Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Current Therapeutic Targets in Cancer Cachexia: A Pathophysiologic Approach.
   Kadakia KC, Hamilton-Reeves JM, Baracos VE. · · 2023 · cited 38× · PMID 37290034 · DOI 10.1200/edbk_389942
2. 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.
   Maeng CH, Kim BH, Chon J, Kang WS, et al · · 2022 · cited 23× · PMID 35410294 · DOI 10.1186/s13063-022-06221-z
3. Impact of Cancer Cachexia on Cardiac and Skeletal Muscle: Role of Exercise Training.
   Bordignon C, Dos Santos BS, Rosa DD. · · 2022 · cited 21× · PMID 35053505 · DOI 10.3390/cancers14020342
4. Multicomponent Interventions for Adults With Cancer Cachexia: A Systematic Review.
   Bowers M, Petrasso C, McLuskie A, Bayly J, et al · · 2025 · cited 6× · PMID 40012451 · DOI 10.1002/jcsm.13716
5. Deciphering molecular crosstalk mechanisms between skeletal muscle atrophy and KRAS-mutant pancreatic cancer: a literature review.
   Guo Y, Han S, Yu W, Xu Y, et al · · 2025 · cited 3× · PMID 39925900 · DOI 10.21037/hbsn-24-282