Cancer, Cancer Survivor
Conditions
Keywords
cancer, herbal medicine, traditional chinese medicine, chinese herbal medicine, tcm, complementary, alternative, fatigue, Cancer-related fatigue
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.
Interventions
None listed
Sponsors
Thong Chai Institute of Medical Research
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pre-post values of EORTC QLQ-C30 questionnaire test scores | 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
| Measure | Time frame |
|---|---|
| Incidence of unanticipated adverse events or severe adverse events: estimated to be <= 10% | From enrollment to the end of treatment at 10 months |
| Pre-post values of Alanine aminotransferase (ALT) | From enrollment to the end of treatment at 10 months |
| Pre-post values of Aspartate aminotransferase (AST) | From enrollment to the end of treatment at 10 months |
| Pre-post values of albumin-to-creatinine ratio (ACR) | From enrollment to the end of treatment at 10 months |
Countries
Singapore
Outcome results
None listed