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

Thong Chai Institute of Medical Research

Status: Invitation-only

Conditions: Cancer Survivor; Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT06807515

TCIMR-FLNC1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

24 participants in 1 patient group

FLNC Group