Neoplasms

Digestive System Diseases

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Gland and Hormone Related Diseases

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Rare Diseases

Stomach Neoplasms

Lung Neoplasms

Pancreatic Neoplasms

Wasting Syndrome

Cachexia

Biliary Tract Neoplasms

Syndrome

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Biliary Tract Diseases

Weight Loss

Body Weight

Body Weight Changes

Thinness

Metabolic Diseases

Nutrition Disorders

Stomach Cancer

Pancreatic Cancer

Biliary Tract Cancer

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

All Drugs and Chemicals

Other Dietary Supplements

Ibuprofen

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Omega 3 Fatty Acid

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

Multi-modal intervention

Chi Hoon Maeng, M.D.

Bo-Hyung Kim, M.D.

Kil Yeon Lee, M.D.

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.

\[PICOT\] 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

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

Effect of Multi-modal Intervention Care on Cachexia in Patients With Advanced Cancer Compared to Conventional Management (MIRACLE): An Open-label, Phase 2 Tria

After anonymizing the patient's confidential information, it can be converted into data and shared.

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)

The average of the change (kg) from baseline at week 7 and change from baseline at week 13 measured by the calibrated 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.

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.

Assessed by the investigator, based on toxicity grade (according to the National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] v5.0)

National Research Foundation of Korea

Kil Yeon Lee

Professor

Spots Global Cancer Trial Database for precachexia

Every month we try and update this database with for precachexia cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for precachexia

Every month we try and update this database with for precachexia cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for precachexia cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.