Clinical trial NCT06807515: Pilot Observational Study and Safety Analysis of FL Nourish Capsules in Cancer Patients in Remission
Official title: Pilot Observational Study and Safety Analysis of FL Nourish Capsules in Cancer Patients in Remission
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Cancer
Cancer Survivor
Keywords: cancer
herbal medicine
traditional chinese medicine
chinese herbal medicine
tcm
complementary
alternative
fatigue
Cancer-related fatigue
Lead sponsor: Thong Chai Institute of Medical Research
Sponsor class: OTHER
First posted: 2025-02-04
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinical stable, post-treatment cancer patients.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pre-post values of EORTC QLQ-C30 questionnaire test scores
timeFrame: From enrollment to the end of treatment at 10 months
Secondary outcomes:
measure: Incidence of unanticipated adverse events or severe adverse events: estimated to be <= 10%
timeFrame: From enrollment to the end of treatment at 10 months
measure: Pre-post values of Alanine aminotransferase (ALT)
timeFrame: From enrollment to the end of treatment at 10 months
measure: Pre-post values of Aspartate aminotransferase (AST)
timeFrame: From enrollment to the end of treatment at 10 months
measure: Pre-post values of albumin-to-creatinine ratio (ACR)
timeFrame: From enrollment to the end of treatment at 10 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore Thong Chai Medical Institution
state: SG
Study officials:
affiliation: Singapore Thong Chai Medical Institution
name: Huang Fang Zheng, PhD, BS
role: STUDY_DIRECTOR
affiliation: Singapore Thong Chai Medical Institution
name: Renyuan Shen, MS, BA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.