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

NCT04600154 | Unknown

• 1 other identifier: 202004004MIPC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer; Cachexia; Chemotherapy Effect

Keywords

Pancreatic cancer; Cachexia; Randomized controlled trial; Microbiota

Outcome Measures

Primary Outcomes (1)

• 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)

  baseline to 12th week

Secondary Outcomes (2)

• Change in lumbar skeletal muscle index from baseline

  baseline to 12th week

• QLQ-C30 Global health status/QoL

  12th week

Other Outcomes (1)

• Progression free survival

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

Study Arms (2)

MS-20

EXPERIMENTAL

4ml, twice, daily

Drug: MS-20

Placebo

PLACEBO COMPARATOR

4ml, twice, daily

Other: Placebo

Interventions

MS-20 DRUG

Specific fraction from fermented soy milk

Also known as: Chemo young oral solution

MS-20

Placebo OTHER

Fermented soy milk without active component

Placebo

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Microbio Co Ltd: collaborator

Study Sites (1)

Department of Internal Medicine, National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Cachexia

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Study Officials

• Wei-Chih Liao, MD/PhD

  Department of Internal Medicine, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei-Chih Liao, MD/PhD

CONTACT

0972651925; david.ntuh@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: October 23, 2020
• Study Start: August 10, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: January 19, 2023

Record last verified: 2023-01

Locations

TW (1)