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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-10

Study Completion Date

2027-08-09

Brief Summary

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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.

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Detailed Description

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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

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Cancer Cancer Survivor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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FLNC Group

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No