Clinical trial NCT04907864: Effect of Multi-modal Intervention Care on Cachexia in Patients With Advanced Cancer Compared to Conventional Management (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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer
Colorectal Cancer
Pancreatic Cancer
Biliary Tract Cancer
Lung Cancer
Precachexia
Cachexia
Keywords: cachexia
chemotherapy
cancer
multi-modal intervention
NSAID
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
Collaborators: name: National Research Foundation of Korea
First posted: 2021-06-01
Enrollment: 112
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An open-label, randomized phase 2 trial
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: Median change (kilogram, kg) in total lean body mass (LBM)
timeFrame: Change of value between baseline and week13
measure: Median change (kg) in handgrip strength
timeFrame: Change of value between baseline and week13
Secondary outcomes:
measure: Median change (kg) in fat mass
timeFrame: Change of value between baseline and week13
measure: Median change (kg) in total body mass
timeFrame: Change of value between baseline and week13
measure: Median change (kg) in body weight (kg)
timeFrame: Change of value between baseline and week13
measure: Median change (kg) in lean body mass of trunk
timeFrame: Change of value between baseline and week13
measure: Median change (kg) in lean body mass of both upper and lower extremities
timeFrame: Change of value between baseline and week13
measure: Change from Anorexia-Cachexia scale
timeFrame: Change of value between baseline and week 13
measure: Change in quality of life (QoL)
timeFrame: Change of value between baseline and week 13
measure: Rate of toxicity with clinical significance, and possible relationship to either study intervention
timeFrame: Change of value between baseline and week 13
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
Study officials:
affiliation: Kyung Hee University Hospital
name: Kil Yeon Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.