Effect of Chinese herbal medicine formula on progression-free survival among patients with metastatic colorectal cancer: Study protocol for a multi-center, double-blinded, randomized, placebo-controlled trial

Abstract

Introduction Metastatic colorectal cancer (mCRC) causes high cancer-related morbidity and mortality worldwide. Although chemotherapy and targeted agents treatment improve median survival and 5-year survival rates, there is only one-third of patients who adhere to treatment protocol until the pause of disease progression. Hezhong granule is a traditional Chinese herbal formula used for mCRC, which has shown good potential in alleviating the adverse effects of chemotherapy, enhancing the effectiveness of chemotherapy, and improving the quality of life. Therefore, the purpose of the study is to further validate the clinical efficacy and safety of the Chinese herbal medicine formula named Hezhong (HZ) in combination with standard chemotherapy and cetuximab (CET) or bevacizumab (BV) for treating mCRC. Methods In this multi-center, randomized, double-blinded, placebo-controlled trial, 360 eligible mCRC patients who will be randomly assigned to Hezhong or placebo group with a 1: 1 ratio. Participants in the Hezhong group will receive standard chemotherapy and CET or BV plus Hezhong Granule until the pause of disease progression, death, the exhibition of intolerable toxicity, or up to 6 months, while the placebo group will treat with standard chemotherapy and CET or BV plus placebo. The primary endpoint is progression-free survival (PFS). The secondary endpoints are overall survival (OS), objective response rate (ORR), safety, quality of life years (QOL), and chemotherapy-induced nausea and vomiting (CINV). Expected results The expected results of this trial are to improve the PFS and QOL of patients with mCRC and provide evidence-based recommendations for the treatment of mCRC with traditional Chinese medicine in China. Trial registration The trial has been registered with the Chinese Clinical Trial Registry (ChiCTR). The trial registration number was ChiCTR2100041643.

Preserving or peeling the inferior mesenteric arterial sheath during laparoscopic rectal cancer surgery: a prospective study of surgical outcomes

“…Like artemisinin, which can effectively treat malaria, Chinese herbal medicine has achieved therapeutic effects on colorectal cancer in previous practices. Some special ingredients contained in Chinese herbal medicine can kill tumor cells, and the treatment of colorectal cancer with traditional Chinese medicine has been included in the treatment guidelines of CSCO [ 11 – 13 ]. Laparoscopic radical resection of rectal cancer is a key component of these techniques.…”

Meta‐analysis on the efficacy of Traditional Chinese Medicine in enhancing surgical site wound healing post‐colorectal surgery

“… 13 Similarly, the Hezhong granule, a Chinese herbal formula, has shown potential in alleviating the adverse effects of chemotherapy, enhancing the effectiveness of chemotherapy and improving the quality of life in metastatic CRC patients. 14 …”

“…For instance, the Insect Compound Particle (CYFF), a TCM compound, has been noted for its potential in reducing the toxicity associated with CRC chemotherapy and enhancing the anti‐tumour effect, although high‐quality clinical evidence remains to be established 13 . Similarly, the Hezhong granule, a Chinese herbal formula, has shown potential in alleviating the adverse effects of chemotherapy, enhancing the effectiveness of chemotherapy and improving the quality of life in metastatic CRC patients 14 …”

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“…To date, the postoperative treatment of patients with lower rectal cancer, mainly through drugs and biofeedback methods, has achieved some therapeutic effects, although the expected goal remains unattained. Traditional Chinese medicines, such as hip baths, acupuncture, and massage, have great advantages in promoting anal recovery with significant therapeutic effects[ 3 ]. Acupuncture treatment has a good effect on postoperative anal function recovery in patients with lower rectal cancer and is simple to perform, inexpensive, and safe.…”