UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056598 |
|---|---|
| Receipt number | R000064680 |
| Scientific Title | A Pilot Study on Nutritional Guidance and Changes in Gut Microbiota in Lung Cancer Patients Undergoing ICI Therapy |
| Date of disclosure of the study information | 2024/12/28 |
| Last modified on | 2024/12/28 15:32:56 |
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Basic information
Public title
A Pilot Study on Nutritional Guidance and Changes in Gut Microbiota in Lung Cancer Patients Undergoing ICI Therapy
Acronym
A Pilot Study on Nutritional Guidance and Changes in Gut Microbiota in Lung Cancer Patients Undergoing ICI Therapy
Scientific Title
A Pilot Study on Nutritional Guidance and Changes in Gut Microbiota in Lung Cancer Patients Undergoing ICI Therapy
Scientific Title:Acronym
Nutritional Guidance and Changes in Gut Microbiota in Lung Cancer Patients Undergoing ICI Therapy
Region
| Japan |
Condition
Condition
Advanced Stage NSCLC
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether providing nutritional guidance on dietary fiber intake, in addition to conventional nutritional counseling, affects changes in the gut microbiota of lung cancer patients undergoing immune checkpoint inhibitor therapy. The purpose of this pilot study is to evaluate the effects of nutritional guidance for lung cancer patients receiving ICI therapy and to examine the resulting changes in their gut microbiota.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in the gut microbiota before and after guidance
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
nutritional guidance
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Patients with stage III or stage IV non-small cell lung cancer.
Patients receiving immune checkpoint inhibitors (ICIs) either as monotherapy or in combination with other treatments.
Patients who have undergone 2 to 4 courses of ICI therapy.
Patients who have not experienced Grade 3 or higher immune-related adverse events (irAEs) from previous treatments.
Key exclusion criteria
Minors (under 18 years old).
Patients with a performance status (PS) of 2 or higher.
Patients currently using or with a history of using antibiotics or proton pump inhibitors (PPIs).
Patients with cachexia.
Patients with inflammatory bowel disease.
Patients with a history of ileus or at risk of other gastrointestinal passage obstructions.
Patients with driver mutations (e.g., EGFR, ALK, ROS-1, BRAF, MET, RET, NTRK, KRAS G12C, HER2).
Patients considered unable to provide informed consent independently due to cognitive decline or other reasons.
Any other patients deemed unsuitable by the attending physician.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiko |
| Middle name | |
| Last name | Seki |
Organization
Teikyo University Hospital
Division name
Department of oncology
Zip code
173-8606
Address
Kaga, Itabashi-ku, Tokyo 173-8606, Japan
TEL
03-3964-1211
niino@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Nobuhiko |
| Middle name | |
| Last name | Seki |
Organization
Teikyo University Hospital
Division name
Department of oncology
Zip code
173-8606
Address
Kaga, Itabashi-ku, Tokyo 173-8606, Japan
TEL
03-3964-1211
Homepage URL
niino@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University Hospital
Institute
Department
Personal name
Funding Source
Organization
Teikyo University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teikyo University Hospital
Address
Kaga, Itabashi-ku, Tokyo 173-8606, Japan
Tel
03-3964-1211
niino@med.teikyo-u.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 | 12 | Month | 28 | 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 | 12 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 28 | Day |
Last modified on
| 2024 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064680
