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

Primary Purpose

Pancreatic Cancer, Cachexia, Chemotherapy Effect

Status

Recruiting

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

MS-20

Placebo

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Pancreatic cancer, Cachexia, Randomized controlled trial, Microbiota

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Male or female subjects aged between 20 and 75 years old.
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.
ECOG (Eastern Cooperative Oncology Group Performance status) scale between 0 and 2.
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.
The subject is able to provide written informed consent by himself/herself and agrees to comply with all protocol requirements.
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:

The subject has soybean allergy.
The subject is pregnant or lactating.
The subject has received or is receiving chemotherapy.
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).
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.
The subject has received any steroids, immunosuppressant or anti-inflammation drugs within 14 days prior to visit 2 (Day 1)..
The subject has received probiotics or prebiotics within 14 days prior to visit 2 (Day 1).
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.
The subject has active inflammatory bowel disease or gastric ulcer.
The subject currently is participating in studies involving other investigational drugs, medical devices, functional foods, or cosmetics.
The subject is considered by the investigator as not suitable for the trial.
The subject is judged by the investigator as not suitable for the trial due to concerns about possible non-compliance or severe concomitant illnesses.

Sites / Locations

Department of Internal Medicine, National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MS-20

Placebo

Arm Description

4ml, twice, daily

Outcomes

Primary Outcome Measures

Change in cachexia staging score from baseline

Cachexia 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)

Secondary Outcome Measures

Change in lumbar skeletal muscle index from baseline

Lumbar 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 vertebra

QLQ-C30 Global health status/QoL

Linear transformation of Global health status/QoL score of QLQ-C30

Full Information

NCT ID

NCT04600154

First Posted

September 21, 2020

Last Updated

January 17, 2023

Sponsor

National Taiwan University Hospital

Collaborators

Microbio Co Ltd

1. Study Identification

Unique Protocol Identification Number

NCT04600154

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 10, 2021 (Actual)

Primary Completion Date

June 30, 2023 (Anticipated)

Study Completion Date

June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Taiwan University Hospital

Collaborators

Microbio Co Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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: 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. 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.)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer, Cachexia, Chemotherapy Effect

Keywords

Pancreatic cancer, Cachexia, Randomized controlled trial, Microbiota

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MS-20

Arm Type

Experimental

Arm Description

4ml, twice, daily

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

4ml, twice, daily

Intervention Type

Drug

Intervention Name(s)

MS-20

Other Intervention Name(s)

Chemo young oral solution

Intervention Description

Specific fraction from fermented soy milk

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Fermented soy milk without active component

Primary Outcome Measure Information:

Title

Change in cachexia staging score from baseline

Description

Cachexia 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)

Time Frame

baseline to 12th week

Secondary Outcome Measure Information:

Title

Change in lumbar skeletal muscle index from baseline

Description

Lumbar 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 vertebra

Time Frame

baseline to 12th week

Title

QLQ-C30 Global health status/QoL

Description

Linear transformation of Global health status/QoL score of QLQ-C30

Time Frame

12th week

Other Pre-specified Outcome Measures:

Title

Progression free survival

Description

Time from enrollment to progressive disease (PD) as assessed by Response Evaluation Criteria In Solid Tumours (RECIST) 1.1

Time Frame

From enrollment to progressive disease, or censored at end of study (20th week)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female subjects aged between 20 and 75 years old. 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. ECOG (Eastern Cooperative Oncology Group Performance status) scale between 0 and 2. 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. The subject is able to provide written informed consent by himself/herself and agrees to comply with all protocol requirements. The subject agrees to comply with the following two requirements: comply with all follow-up visit requirements according to the trial protocol. comply with all requirement regarding fecal samples collection, storage and delivery according to the trial protocol. Exclusion Criteria: The subject has soybean allergy. The subject is pregnant or lactating. The subject has received or is receiving chemotherapy. 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). 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. The subject has received any steroids, immunosuppressant or anti-inflammation drugs within 14 days prior to visit 2 (Day 1).. The subject has received probiotics or prebiotics within 14 days prior to visit 2 (Day 1). The subject has abnormal organ and bone marrow function as defined below: 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). 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. The subject has active inflammatory bowel disease or gastric ulcer. The subject currently is participating in studies involving other investigational drugs, medical devices, functional foods, or cosmetics. The subject is considered by the investigator as not suitable for the trial. The subject is judged by the investigator as not suitable for the trial due to concerns about possible non-compliance or severe concomitant illnesses.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wei-Chih Liao, MD/PhD

Phone

0972651925

david.ntuh@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wei-Chih Liao, MD/PhD

Organizational Affiliation

Department of Internal Medicine, National Taiwan University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Internal Medicine, National Taiwan University Hospital

City

Taipei

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Liao Wei-Chih, MD/PhD

12. IPD Sharing Statement

Learn more about this trial

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

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