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

Colorectal Cancer Clinical Trial

— MIRACLE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04907864
• Other study ID #: KHMC-HUMANITAS-01
• Status: Recruiting
• Phase: Phase 2
• Start date: January 31, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: May 2021
• Source: Kyunghee University Medical Center
• Contact: Chi Hoon Maeng, M.D.
• Phone: +82-2-958-2965
• Email: mchihoon[@]khu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: June 30, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms
• Cachexia
• Colorectal Cancer
• Gastric Cancer
• Lung Cancer
• Pancreatic Cancer

Intervention

Combination Product:
• Multi-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

Locations

Country	Name	City	State
Korea, Republic of	Kyung Hee University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Kil Yeon Lee	National Research Foundation of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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