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| Name | Class |
|---|---|
| National Research Foundation of Korea | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MIC | Experimental | Multi-modal intervention |
|
| CPC | No Intervention | Conventional Palliative Care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-modal intervention | Combination Product | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Change of value between baseline and week13 |
| 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) | Change of value between baseline and week13 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Change of value between baseline and week13 |
| Median change (kg) in total body mass |
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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
Adequate organ functions
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Kil Yeon Lee, M.D. | Kyung Hee University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyung Hee University Hospital | Recruiting | Seoul | 02447 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35410294 | Derived | 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. |
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After anonymizing the patient's confidential information, it can be converted into data and shared.
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An open-label, randomized phase 2 trial
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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 of value between baseline and week13 |
| 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 | Change of value between baseline and week13 |
| 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) | Change of value between baseline and week13 |
| 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 of value between baseline and week13 |
| 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 of value between baseline and week 13 |
| 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. | Change of value between baseline and week 13 |
| 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) | Change of value between baseline and week 13 |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D015179 | Colorectal Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D001661 | Biliary Tract Neoplasms |
| D008175 | Lung Neoplasms |
| D002100 | Cachexia |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D001660 | Biliary Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013851 | Thinness |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| C405603 | Omacor |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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