UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055664 |
|---|---|
| Receipt number | R000063613 |
| Scientific Title | Correlation Between Adverse Events and Gut Microbiota Alterations During Postoperative Adjuvant Chemotherapy for Colon Cancer |
| Date of disclosure of the study information | 2024/11/30 |
| Last modified on | 2024/09/29 01:55:37 |
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Basic information
Public title
Correlation Between Adverse Events and Gut Microbiota Alterations During Postoperative Adjuvant Chemotherapy for Colon Cancer
Acronym
Correlation Between Adverse Events and Gut Microbiota Alterations During Postoperative Adjuvant Chemotherapy for Colon Cancer
Scientific Title
Correlation Between Adverse Events and Gut Microbiota Alterations During Postoperative Adjuvant Chemotherapy for Colon Cancer
Scientific Title:Acronym
Correlation Between Adverse Events and Gut Microbiota Alterations During Postoperative Adjuvant Chemotherapy for Colon Cancer
Region
| Japan |
Condition
Condition
Colon Cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to clarify the relationship between changes in the intestinal microbiota due to adjuvant chemotherapy (specifically 3 months of CAPOX) after colorectal cancer surgery and adverse events, including bowel function.
Basic objectives2
Others
Basic objectives -Others
By examining specific intestinal microbiota that influence the exacerbation of adverse events, this study holds significance in contributing to the development of optimal probiotics aimed at reducing adverse events.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in the intestinal microbiota before and after adjuvant chemotherapy for colon cancer
Key secondary outcomes
Changes in bowel function before and after adjuvant chemotherapy for colon cancer and its correlation with adverse events
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who have provided written consent for participation in this study
Patients who are 20 years or older but under 80 years old at the time of consent
Patients diagnosed with colon cancer (including appendiceal, cecal, ascending, transverse, descending, or sigmoid colon cancer) who have undergone primary tumor resection
Patients diagnosed with Stage III cancer
Patients eligible for adjuvant chemotherapy with either capecitabine and oxaliplatin (for 3 or 6 months) or capecitabine (for 6 months)
Key exclusion criteria
Patients with rectal cancer
Patients who have taken antibiotics orally for more than one week before surgery
Patients with severe liver dysfunction or severe renal dysfunction
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Sohei |
| Middle name | |
| Last name | Akuta |
Organization
Saitama Medical University International Medical Center
Division name
Gastrointestinal Surgery
Zip code
350-1298
Address
1397-1, Yamane, Hidaka-City, Saitama-Pref, Japan
TEL
042-984-4111
sa46101@5931.saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Sohei |
| Middle name | |
| Last name | Akuta |
Organization
Saitama Medical University International Medical Center
Division name
Gastrointestinal Surgery
Zip code
350-1298
Address
1397-1, Yamane, Hidaka-City, Saitama-Pref, Japan
TEL
042-984-4111
Homepage URL
sa46101@5931.saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University International Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University International medical center
Address
1397-1, Yamane, Hidaka-City, Saitama-Pref, Japan
Tel
042-984-4523
chikens@saitama-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2024 | Year | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The intestinal microbiota will be identified from stool samples collected three times: before surgery, before adjuvant chemotherapy, and after adjuvant chemotherapy. A comprehensive assessment of distribution, occupancy rate, and quantity will be conducted. A statistical comparison between the pre- and post-chemotherapy groups will be performed using two-group analysis.
Bowel function will be evaluated through questionnaires administered three times: before surgery, and before and after adjuvant chemotherapy. Additionally, questionnaires regarding adverse events (at the start of each chemotherapy cycle) will be conducted.
Factors such as gender, age, BMI, American Society of Anesthesiologists - Physical Status, medical history, probiotic use (including lactic acid beverages), antibiotic use, and chemotherapy completion rates will be examined.
Management information
Registered date
| 2024 | Year | 09 | Month | 29 | Day |
Last modified on
| 2024 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063613
