Biliary Tract Cancer, Cachexia, Colorectal Cancer, Gastric Cancer, Lung Cancer, Pancreatic Cancer, Precachexia
Conditions
Keywords
cachexia, chemotherapy, cancer, multi-modal intervention, NSAID
Brief 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. 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.
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
Interventions
COMBINATION_PRODUCTMulti-modal intervention
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
Sponsors
National Research Foundation of Korea
Kil Yeon Lee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
An open-label, randomized phase 2 trial
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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 * Normal: Neither pre-cachexia Nor cachexia * 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median change (kilogram, kg) in total lean body mass (LBM) | Change of value between baseline and week13 | 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) |
| Median change (kg) in handgrip strength | Change of value between baseline and week13 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median change (kg) in body weight (kg) | Change of value between baseline and week13 | The average of the change (kg) from baseline at week 7 and change from baseline at week 13 measured by the calibrated scale |
| Median change (kg) in lean body mass of trunk | Change of value between baseline and week13 | 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) |
| Median change (kg) in lean body mass of both upper and lower extremities | Change of value between baseline and week13 | 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) |
| Median change (kg) in fat mass | Change of value between baseline and week13 | 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 in quality of life (QoL) | Change of value between baseline and week 13 | 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. |
| Rate of toxicity with clinical significance, and possible relationship to either study intervention | Change of value between baseline and week 13 | 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 from Anorexia-Cachexia scale | Change of value between baseline and week 13 | Functional Assessment of Anorexia/Cachexia Treatment (FAACT) version 4, The higher the score, the better the quality of life (QoL) with range 0-156. |
| Median change (kg) in total body mass | Change of value between baseline and week13 | 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) |
Countries
South Korea
Contacts
Primary ContactChi Hoon Maeng, M.D.
Backup ContactBo-Hyung Kim, M.D.
Outcome results
None listed