CancerNCT06807515
Pilot Observational Study and Safety Analysis of FL Nourish Capsules in Cancer Patients in Remission
An observational study of Cancer and Cancer Survivor, run by Thong Chai Institute of Medical Research at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Cancer, Cancer Survivor
- How many people
- 24 participants
- Where
- 1 siteSingapore
- Study dates
- 10 Feb 2025to 9 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinical stable, post-treatment cancer patients.
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site
Singapore Thong Chai Medical Institution
Singapore, SG, 169874
About this study
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.
Read the 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.
- Conditions
- Cancer, Cancer Survivor
- Keywords
- cancer, herbal medicine, traditional chinese medicine, chinese herbal medicine, tcm, complementary, alternative, fatigue, Cancer-related fatigue
- Medical subject headings
- Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| FLNC Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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%
Measured: From enrollment to the end of treatment at 10 months
Pre-post values of Alanine aminotransferase (ALT)
Measured: From enrollment to the end of treatment at 10 months
Pre-post values of Aspartate aminotransferase (AST)
Measured: From enrollment to the end of treatment at 10 months
Pre-post values of albumin-to-creatinine ratio (ACR)
Measured: From enrollment to the end of treatment at 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start10 Feb 2025
- Primary completion9 Feb 2027 (estimated)
- Study completion9 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thong Chai Institute of Medical Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huang Fang Zheng, PhD, BS, Study director, Singapore Thong Chai Medical InstitutionRenyuan Shen, MS, BA, Principal investigator, Singapore Thong Chai Medical Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06807515
- Sponsor's protocol ID
- TCIMR-FLNC1
- Status last verified
- Apr 2025
- First submitted
- 22 Jan 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39840742
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Observational Study and Safety Analysis of FL Nourish Capsules in Cancer Patients in Remission
- ClinicalTrials.gov ID
- NCT06807515
- Acronym / sponsor ID
- TCIMR-FLNC1
- Conditions
- Cancer, Cancer Survivor
- Keywords
- cancer, herbal medicine, traditional chinese medicine, chinese herbal medicine, tcm, complementary, alternative, fatigue
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Thong Chai Institute of Medical ResearchUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 9 Feb 2027 (estimated)
- Study completion
- 9 Aug 2027 (estimated)
- First posted
- 4 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FLNC Group | – | – |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinical stable, post-treatment cancer patients.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
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
Pre-post values of Alanine aminotransferase (ALT)
Time frame: 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
Pre-post values of albumin-to-creatinine ratio (ACR)
Time frame: From enrollment to the end of treatment at 10 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Background: PubMed 39840742Chan 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Huang Fang Zheng, PhD, BS study director
Singapore Thong Chai Medical Institution
Renyuan Shen, MS, BA principal investigator
Singapore Thong Chai Medical Institution
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Cancer Survivor, run by Thong Chai Institute of Medical Research at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-post values of EORTC QLQ-C30 questionnaire test scores (time frame: From enrollment to the end of treatment at 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06807515, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.