NCT06807515

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
15mo left

Started Feb 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Feb 2025Aug 2027

First Submitted

Initial submission to the registry

January 22, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 4, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

February 10, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2027

Last Updated

April 9, 2025

Status Verified

April 1, 2025

Enrollment Period

2 years

First QC Date

January 22, 2025

Last Update Submit

April 7, 2025

Conditions

CancerCancer Survivor

Keywords

cancerherbal medicinetraditional chinese medicinechinese herbal medicinetcmcomplementaryalternativefatigueCancer-related fatigue

Outcome Measures

Primary Outcomes (1)

  • Pre-post values of EORTC QLQ-C30 questionnaire test scores

    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 Outcomes (4)

  • Incidence of unanticipated adverse events or severe adverse events: estimated to be <= 10%

    From enrollment to the end of treatment at 10 months

  • Pre-post values of Alanine aminotransferase (ALT)

    From enrollment to the end of treatment at 10 months

  • Pre-post values of Aspartate aminotransferase (AST)

    From enrollment to the end of treatment at 10 months

  • Pre-post values of albumin-to-creatinine ratio (ACR)

    From enrollment to the end of treatment at 10 months

Study Arms (1)

FLNC Group

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Clinical stable, post-treatment cancer patients.

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore Thong Chai Medical Institution

Singapore, SG, 169874, Singapore

Location

Related Publications (1)

  • Chan A, Chan D, Ng DQ, Zheng HF, Tan QM, Tan CJ, Toh JHM, Yap NY, Toh YL, Ke Y, Wang ECA, Lim QPN, Ho HK, Chew L, Tan TJ. HEalth-Related Quality of Life-Intervention in Survivors of Breast and Other Cancers Experiencing Cancer-Related Fatigue and Associated Cognitive Symptoms Using TraditionAL Chinese Medicine: The 'HERBAL' Trial. Integr Cancer Ther. 2025 Jan-Dec;24:15347354251314514. doi: 10.1177/15347354251314514.

    PMID: 39840742BACKGROUND

MeSH Terms

Conditions

NeoplasmsFatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Huang Fang Zheng, PhD, BS

    Singapore Thong Chai Medical Institution

    STUDY DIRECTOR

  • Renyuan Shen, MS, BA

    Singapore Thong Chai Medical Institution

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2025

First Posted

February 4, 2025

Study Start

February 10, 2025

Primary Completion (Estimated)

February 9, 2027

Study Completion (Estimated)

August 9, 2027

Last Updated

April 9, 2025

Record last verified: 2025-04

Locations

SG(1)