Qu-Shi-Jie-Du Decoction for Prevention of Recurrence and Metastasis in High-Risk Stage II/III Colon Cancer: Study Protocol for a Double-Blind, Randomized, Placebo-Controlled Trial.

Researchers are studying whether a traditional Chinese herbal formula called Qu-Shi-Jie-Du decoction (QSJDD) can help prevent colon cancer from coming back or spreading after surgery and chemotherapy. This study involves 336 patients with high-risk stage II or III colon cancer from 10 hospitals in China. After completing standard cancer treatment, half the patients will receive QSJDD herbal granules while the other half receives a placebo (inactive treatment) for 6 months. Researchers will then follow patients for 3 years to see who remains cancer-free.

The study is particularly important because many colon cancer patients experience recurrences or metastases (cancer spreading to other organs, especially the liver) even after treatment, which reduces survival rates. Early research suggests QSJDD may work by strengthening the immune system, reducing inflammation, and stopping tumor growth. Previous smaller studies showed promising results in reducing liver metastasis in colon cancer patients.

This is a rigorous, double-blind study, meaning neither patients nor doctors know who receives the real herbal formula until the study ends. Researchers will track disease-free survival rates at 1, 2, and 3 years, overall survival, and any side effects. They'll also analyze blood samples and gut bacteria to understand how QSJDD might work to prevent cancer spread.

While this study focuses on herbal medicine rather than acupuncture specifically, it represents the broader integration of Traditional Chinese Medicine approaches with conventional cancer care. If successful, QSJDD could offer patients an additional option to improve outcomes after colon cancer treatment. If you're interested in integrative approaches to cancer care, consult with a qualified TCM practitioner experienced in oncology support.

This multicentre, double-blind, randomized, placebo-controlled trial investigates Qu-Shi-Jie-Du decoction (QSJDD) for preventing recurrence and metastasis in high-risk stage II/III colon cancer. The study will enroll 336 patients across 10 Chinese hospitals, randomizing them 1:1 to receive either QSJDD compound granules or placebo for 6 months post-surgery and chemotherapy, with 3-year follow-up and biannual evaluations.

Primary endpoint is 3-year disease-free survival (DFS) rate. Secondary endpoints include 1- and 2-year DFS rates, overall survival, and Traditional Chinese Medicine Dampness Syndrome Scale changes. Safety monitoring and biomarker analysis (blood and gut microbiome) will assess QSJDD's mechanisms in delaying metastasis.

Preliminary evidence suggests QSJDD reduces liver metastasis through immune enhancement, anti-inflammatory effects, and tumor growth inhibition. This trial aims to provide robust clinical evidence for QSJDD's efficacy and safety as adjunctive therapy in colon cancer management, addressing the significant clinical challenge of recurrence and metastasis in this high-risk population.