Pilot Observational Study and Safety Analysis of FL Nourish Capsules in Cancer Patients in Remission

April 7, 2025 updated by: Thong Chai Institute of Medical Research
This is a single-centre, observational prospective study of cancer patients in remission administering FL Nourish capsules (FLNC), a proprietary Chinese Medicine herbal supplement, for the treatment of symptoms associated with qi deficiency and blood stasis syndrome.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

Consultation data will be analysed from up to 24 cancer patients in remission receiving routine treatment at Singapore Thong Chai Medical Institution. Each participant will visit the institution in accordance with the protocol which includes up to 9 months of FL Nourish capsule (FLNC) use and up to 8 consultation visits. Participants will be evaluated based on consultation data, questionnaire data, routine blood test data and self-reporting of adverse events or severe adverse events. As this is a non-interventional observational study, all participants would have received FLNC prescriptions according to routine diagnostic and prescribing standards, and there were no additional visits required aside from routine follow up consultations.

Study Type

Observational

Enrollment (Estimated)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
    • SG
      • Singapore, SG, Singapore, 169874
        • Singapore Thong Chai Medical Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Clinical stable, post-treatment cancer patients.

Description

Inclusion Criteria:

  • Aged 21-80;
  • Cancer diagnosis ≤ 5 years;
  • Received treatment with no current evidence of recurrence, with predicted life expectancy of 12 months and above;
  • On regular follow-up with lab tests scheduled every 1-9 months;
  • Recent (<=3 months) blood test report(s) available on first study visit
  • Diagnosed with the TCM syndrome of Qi deficiency and Blood stasis by the primary physician: experience 2 major symptoms coupled with typical tongue and pulse conditions; 2 major symptoms and 1 possible symptom coupled with tongue and pulse conditions; and 1 major symptom and at least 2 possible symptoms coupled with tongue and pulse conditions;

Exclusion Criteria:

  • On active cancer treatment such as IV chemotherapy or radiotherapy or oral targeted therapy (excluding HRT and oral chemotherapy);
  • Scheduled for IV chemotherapy, radiotherapy or surgery within the next 1 year from recruitment date;
  • Diagnosed with active disease of the liver, kidney, brain, blood, blood vessels; with mental health conditions or are mentally incapacitated;
  • Pregnant women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
FLNC Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pre-post values of EORTC QLQ-C30 questionnaire test scores
Time Frame: From enrollment to the end of treatment at 10 months
0 is equivalent to a low QoL/functioning/symptom score and 100 indicates the best posssible QoL/functioning/symptom score.
From enrollment to the end of treatment at 10 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of unanticipated adverse events or severe adverse events: estimated to be <= 10%
Time Frame: From enrollment to the end of treatment at 10 months
From enrollment to the end of treatment at 10 months
Pre-post values of Alanine aminotransferase (ALT)
Time Frame: From enrollment to the end of treatment at 10 months
From enrollment to the end of treatment at 10 months
Pre-post values of Aspartate aminotransferase (AST)
Time Frame: From enrollment to the end of treatment at 10 months
From enrollment to the end of treatment at 10 months
Pre-post values of albumin-to-creatinine ratio (ACR)
Time Frame: From enrollment to the end of treatment at 10 months
From enrollment to the end of treatment at 10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thong Chai Institute of Medical Research

Investigators

  • Study Director: Huang Fang Zheng, PhD, BS, Singapore Thong Chai Medical Institution
  • Principal Investigator: Renyuan Shen, MS, BA, Singapore Thong Chai Medical Institution

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2025

Primary Completion (Estimated)

February 9, 2027

Study Completion (Estimated)

August 9, 2027

Study Registration Dates

First Submitted

January 22, 2025

First Submitted That Met QC Criteria

January 28, 2025

First Posted (Actual)

February 4, 2025

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 7, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TCIMR-FLNC1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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