$0.00
Shopping Cart
Facebook-f Instagram
DONATE
Donate

Clinical Trial Record

Return to Clinical Trials

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

2021-08-10

2023-06-30

2023-06-30

40

Study Overview

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

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.

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.)

  • Pancreatic Cancer
  • Cachexia
  • Chemotherapy Effect
  • DRUG: MS-20
  • OTHER: Placebo
  • 202004004MIPC

Study Record Dates

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

2020-09-21  

N/A  

2023-01-17  

2020-10-19  

N/A  

2023-01-19  

2020-10-23  

N/A  

2023-01  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Quadruple

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: MS-20

4ml, twice, daily

DRUG: MS-20

  • Specific fraction from fermented soy milk
PLACEBO_COMPARATOR: Placebo

4ml, twice, daily

OTHER: Placebo

  • Fermented soy milk without active component
Primary Outcome MeasuresMeasure DescriptionTime Frame
Change in cachexia staging score from baselineCachexia staging score: a score to gauge the severity of cachexia: non-cachexia (0-2), pre-cachexia (3-4), cachexia (5-8), and refractory cachexia (9-12)baseline to 12th week
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Change in lumbar skeletal muscle index from baselineLumbar skeletal muscle index (SMI) is calculated as the mean of sum of cross-sectional areas of skeletal muscles on two consecutive CT images containing the third lumbar vertebrabaseline to 12th week
QLQ-C30 Global health status/QoLLinear transformation of Global health status/QoL score of QLQ-C3012th week

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Wei-Chih Liao, MD/PhD

Phone Number: 0972651925

Email: david.ntuh@gmail.com

Participation Criteria

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:
20 Years

Accepts Healthy Volunteers:
1

    Inclusion Criteria:
    1. Male or female subjects aged between 20 and 75 years old. 2. Patients with histologically- or cytologically-confirmed unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) who plan to receive gemcitabine alone or in combination with other chemotherapeutic agents. 3. ECOG (Eastern Cooperative Oncology Group Performance status) scale between 0 and 2. 4. Female subjects of childbearing potential must use at least two forms of birth control. Subjects who are postmenopausal (defined as amenorrhea for 12 consecutive months) , surgically sterilized (ie, hysterectomy, bilateral oophorectomy, or bilateral tubal ligation), or have abnormalities of the reproductive tract will be considered as having no childbearing potential. 5. The subject is able to provide written informed consent by himself/herself and agrees to comply with all protocol requirements. 6. The subject agrees to comply with the following two requirements:
    1. comply with all follow-up visit requirements according to the trial protocol. 2. comply with all requirement regarding fecal samples collection, storage and delivery according to the trial protocol.
    Exclusion Criteria:
    1. The subject has soybean allergy. 2. The subject is pregnant or lactating. 3. The subject has received or is receiving chemotherapy. 4. The subject has received any antibiotic, antifungals or antivirals (excluding topical agents and antiviral prophylaxis for hepatitis B virus) within 14 days prior to visit 2 (Day 1). 5. The subject has a clinically significant, currently active or underlying diarrhea (soft or loose stools more than three times in 24 hours) of infectious etiologies. 6. The subject has received any steroids, immunosuppressant or anti-inflammation drugs within 14 days prior to visit 2 (Day 1).. 7. The subject has received probiotics or prebiotics within 14 days prior to visit 2 (Day 1). 8. The subject has abnormal organ and bone marrow function as defined below:
    1. Patients with abnormal liver function tests (serum bilirubin level ≧ 2 times upper limit of normal (ULN), aspartate transaminase (AST) or alanine transaminase (ALT) ≧ 3.0 X ULN). 2. Patients with renal disease or renal dysfunction (serum creatinine ≧ 1.5 X ULN) or estimated glomerular filtration rate (eGFR)< 50 mL/min/1.73 m2. 9. The subject has active inflammatory bowel disease or gastric ulcer. 10. The subject currently is participating in studies involving other investigational drugs, medical devices, functional foods, or cosmetics. 11. The subject is considered by the investigator as not suitable for the trial. 12. The subject is judged by the investigator as not suitable for the trial due to concerns about possible non-compliance or severe concomitant illnesses.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • Microbio Co Ltd
  • PRINCIPAL_INVESTIGATOR: Wei-Chih Liao, MD/PhD, Department of Internal Medicine, National Taiwan University Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

NPCF Pop up

Make-A-Will Month

Snag 6508be92
Learn More
Donate Now Online
Other Ways to Donate