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Enrolling by Invitation

NCT Number: NCT06807515

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

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.

Enrolling by Invitation

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Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Singapore Thong Chai Medical Institution

Singapore, SG, 169874

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. Pre-post values of Alanine aminotransferase (ALT)

    Time frame: From enrollment to the end of treatment at 10 months

  3. Pre-post values of Aspartate aminotransferase (AST)

    Time frame: From enrollment to the end of treatment at 10 months

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

    Time frame: From enrollment to the end of treatment at 10 months

Sponsors and collaborators

Lead sponsor

Thong Chai Institute of Medical Research

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 4, 2025
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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