NCT04600154

MS-20 on Gut Microbiota and Risk/Severity of Cachexia in Pancreatic Cancer Patients

Effects of MS-20 on Gut Microbiota and Risk/Severity of Cachexia in Patients Receiving Chemotherapy for Pancreatic Cancer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Cachexia has been recognized as a direct cause of reduced quality of life complicating in cancer patients. Patients with pancreatic cancer have the highest prevalence in developing severe degrees of cachexia. Providing supportive therapies for these patients may provide a lot of benefit on overarching quality of life and improve overall survival. MS-20 is indicated for treating the symptom of fatigue and loss of appetite induced by chemotherapy in cancer patients. According to the result from pre-clinical study, MS-20 may have potential to attenuate or suppress the resistant phenomena of chemotherapy via alternating gut microbiota profile. In this study, MS-20 effects on on gut microbiota and risk/severity of cachexia will be analyzed in pancreatic cancer patients who under combination therapy with chemotherapy and MS-20.

Detailed description

This is a double-blind, placebo-controlled, investigator-initiated randomized trial to evaluate the effects of MS-20 on gut microbiota and risk/severity of cachexia in patients receiving chemotherapy for pancreatic cancer. Approximately 40 subjects who meet the criteria will be enrolled into the study. The total of study comprises of a 28 days screening period, a 12-week treatment period and a 8-week follow-up period. Potential candidates should provide signed informed consent forms before starting any screening activities. MS-20 or placebo will be orally administered twice per day in treatment period. All medications (especially antibiotics) should be recorded and documented during the study period. The investigator may withdraw a subject from the study if any of the following conditions occurs: 1. Subjects who experiences a serious adverse event (SAE) or intolerable adverse event (AE), or laboratory safety assessments reveal clinically significant hematological or biochemical changes from baseline values. 2. The subject would like to withdraw consent and discontinue from the study at any time, for any reason, without any influence on further treatment. (Patients who withdraw or terminate early from study should proceed to EOT visit for safety evaluation.)

Conditions

• Pancreatic Cancer
• Cachexia
• Chemotherapy Effect

Interventions

Type	Name	Description
DRUG	MS-20	Specific fraction from fermented soy milk
OTHER	Placebo	Fermented soy milk without active component

Timeline

• Start date: 2021-08-10
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2020-10-23
• Last updated: 2023-01-19

Locations

1 site across 1 country: Taiwan