Metabolomic Pathways and Traditional Chinese Medicine Bod... | NCT07489833

Studies
Metabolomic Pathways and Traditional Chinese Medicine Body Constitution in Cancer-related Fatigue

NCT07489833

Sponsor

Chang Gung Memorial Hospital

Status

Not yet recruiting

Last Update Posted

Mar 27, 2026Actual

Enrollment

80Estimated

Phase

Not provided

Conditions

Colorectal Cancer

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 20, 2026Estimated

Primary Completion Date

Dec 31, 2028Estimated

Completion Date

Feb 28, 2029Estimated

First Submitted Date

Mar 18, 2026

First Submission Date that Met QC Criteria

Mar 18, 2026

First Posted Date

Mar 24, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2026

Last Update Posted Date

Mar 27, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to integrate insights from metabolomics and TCMBC to identify biomarkers and physiological pathways associated with CRF.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

80Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Self-report Questionnaire	The study utilizes two instruments. First, the Fatigue Symptom Inventory (FSI) is used to assess fatigue; total scores range from 0 to 127, with higher scores indicating greater fatigue severity. Second, the Body Constitution Questionnaire (BCQ) comprises 16 items, with total scores ranging from 16 to 80.	Change from baseline to 3 months after surgery.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients aged 18 years or older
Diagnosed with stage I to III CRC and scheduled for surgical treatment
Cognitively intact and able to communicate in either Mandarin or Taiwanese
Willing to participate in the study and provide written informed consent.

Exclusion Criteria:

Patients diagnosed with stage IV colorectal cancer
Patients with recurrent colorectal cancer or other concurrent cancers.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Newly diagnosed with stage I to III CRC and scheduled for surgical treatment

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yun-Jen Chou, PhD	Contact	886-3-2118800	3512	yjchou@mail.cgu.edu.tw

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Description

The retained samples consist of plasma processed from whole blood. The cellular components (buffy coat and red blood cells) are discarded, and only the acellular plasma fraction is retained for metabolomic analysis related to fatigue mechanisms.