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2020-01-31
2022-03-31
2022-06-30
112
NCT04907864
Kyunghee University Medical Center
Kyunghee University Medical Center
INTERVENTIONAL
Effect of Multi-modal Intervention Care on Cachexia in Patients With Advanced Cancer Compared to Conventional Management (MIRACLE)
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2021-05-25 | N/A | 2021-05-28 |
2021-05-28 | N/A | 2021-06-01 |
2021-06-01 | N/A | 2021-05 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: MIC Multi-modal intervention | COMBINATION_PRODUCT: Multi-modal intervention
|
| NO_INTERVENTION: CPC Conventional Palliative Care |
| Primary Outcome Measures | 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 |
| Secondary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Chi Hoon Maeng, M.D. Phone Number: +82-2-958-2965 Email: mchihoon@khu.ac.kr |
Study Contact Backup Name: Bo-Hyung Kim, M.D. Phone Number: +82-2-958-9326 Email: bhkim98@khu.ac.kr |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
19 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
