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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Pre-post values of EORTC QLQ-C30 questionnaire test scores [Срок оценки: From enrollment to the end of treatment at 10 months]

Вторичные конечные точки (4)

• Incidence of unanticipated adverse events or severe adverse events: estimated to be <= 10% [Срок оценки: From enrollment to the end of treatment at 10 months]
• Pre-post values of Alanine aminotransferase (ALT) [Срок оценки: From enrollment to the end of treatment at 10 months]
• Pre-post values of Aspartate aminotransferase (AST) [Срок оценки: From enrollment to the end of treatment at 10 months]
• Pre-post values of albumin-to-creatinine ratio (ACR) [Срок оценки: From enrollment to the end of treatment at 10 months]

Критерии участия

Критерии включения

• 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;

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Сингапур · 1 центр

• Singapore Thong Chai Medical Institution — Singapore

Публикации

• 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 PMID 39840742

Идентификаторы

NCT: NCT06807515 · TCIMR-FLNC1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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