Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06596343
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-08
Brief Title:
Evaluating the Benefits of Personalized Traditional Chinese Medicine in Postoperative Treatment for Locally Advanced Colorectal Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Study on the Value of Traditional Chinese Medicine Precision Treatment Based on Syndrome Differentiation in Postoperative Adjuvant Therapy for Locally Advanced Colorectal Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to explore the role of Traditional Chinese Medicine TCM based on syndrome differentiation in reducing chemotherapy side effects lowering the risk of metastasis and recurrence and improving survival rates in postoperative colorectal cancer patients through a prospective single-arm interventional clinical trial
Detailed Description:
Colorectal cancer is the third leading cause of cancer-related deaths worldwide with 19 million new cases and nearly 935000 deaths reported in 2020 In China colorectal cancer ranks third in new cases for both men and women while it ranks fifth in cancer-related deaths among men and second among women It has become a global public health issue and a major threat to peoples health Surgical resection is the primary treatment for colon cancer and can potentially cure the tumor More than 50 of colon cancer patients are diagnosed at locally advanced stages stage II and III Even after curative surgery about 50 of these patients experience tumor recurrence due to undetectable micrometastases that persist post-surgery Most of these patients require adjuvant chemotherapy to eliminate micrometastases and improve cure rates Postoperative adjuvant chemotherapy can eradicate hidden micrometastases and prolong survival in colorectal cancer patients Large clinical trials have shown that adjuvant chemotherapy reduces the recurrence rate by 41 and overall mortality by 33 Thus surgery combined with postoperative adjuvant chemotherapy is the standard treatment approach to cure colon cancer
However about 25 of stage III colorectal cancer patients still relapse despite adjuvant chemotherapy indicating that not all patients benefit from it Additionally postoperative adjuvant chemotherapy can cause numerous side effects The IDEA study reported that grade 3 or higher chemotherapy-related toxicities occurred in 20 of patients receiving 3 months of adjuvant chemotherapy and 369 of patients receiving 6 months These side effects include mucositis vomiting diarrhea febrile neutropenia fatigue hair loss hand-foot syndrome pain redness and peeling of the skin on the palms and soles neurotoxicity and cardiotoxicity The incidence and severity of these side effects vary depending on the specific drugs and administration methods and some side effects such as oxaliplatin-induced peripheral neuropathy can persist long-term significantly affecting patients quality of life
Thus both healthcare providers and patients are seeking additional therapies to reduce toxicity and improve the efficacy of standard treatment In real-world practice many colorectal cancer patients have received Traditional Chinese Medicine TCM as part of their postoperative care and TCM plays a significant role in colorectal cancer prevention and treatment
In TCM colorectal cancer is classified under conditions such as zang du organ toxin chang ji intestinal accumulation and ji ju mass accumulation primarily caused by irregular diet emotional imbalance and deficiency of vital energy qi Although the disease originates in the intestines it is closely related to the spleen stomach liver and kidneys Early-stage disease is dominated by damp-heat and toxin stagnation while later stages are characterized by a deficiency of vital energy with excess pathogenic factors typically involving spleen and kidney yang deficiency qi and blood deficiency or liver and kidney yin deficiency A deficiency in vital energy and yin-yang imbalance are key factors in the development of colorectal cancer Damp-heat accumulation in the intestines leads to stagnation of qi toxin formation and eventual mass formation which is a core mechanism of disease development
This study aims to investigate the role of adding TCM during and after surgery and chemotherapy to enhance the clinical efficacy of adjuvant chemotherapy reduce the occurrence of adverse effects prevent metastasis and recurrence and ultimately improve survival rates
However about 25 of stage III colorectal cancer patients still relapse despite adjuvant chemotherapy indicating that not all patients benefit from it Additionally postoperative adjuvant chemotherapy can cause numerous side effects The IDEA study reported that grade 3 or higher chemotherapy-related toxicities occurred in 20 of patients receiving 3 months of adjuvant chemotherapy and 369 of patients receiving 6 months These side effects include mucositis vomiting diarrhea febrile neutropenia fatigue hair loss hand-foot syndrome pain redness and peeling of the skin on the palms and soles neurotoxicity and cardiotoxicity The incidence and severity of these side effects vary depending on the specific drugs and administration methods and some side effects such as oxaliplatin-induced peripheral neuropathy can persist long-term significantly affecting patients quality of life
Thus both healthcare providers and patients are seeking additional therapies to reduce toxicity and improve the efficacy of standard treatment In real-world practice many colorectal cancer patients have received Traditional Chinese Medicine TCM as part of their postoperative care and TCM plays a significant role in colorectal cancer prevention and treatment
In TCM colorectal cancer is classified under conditions such as zang du organ toxin chang ji intestinal accumulation and ji ju mass accumulation primarily caused by irregular diet emotional imbalance and deficiency of vital energy qi Although the disease originates in the intestines it is closely related to the spleen stomach liver and kidneys Early-stage disease is dominated by damp-heat and toxin stagnation while later stages are characterized by a deficiency of vital energy with excess pathogenic factors typically involving spleen and kidney yang deficiency qi and blood deficiency or liver and kidney yin deficiency A deficiency in vital energy and yin-yang imbalance are key factors in the development of colorectal cancer Damp-heat accumulation in the intestines leads to stagnation of qi toxin formation and eventual mass formation which is a core mechanism of disease development
This study aims to investigate the role of adding TCM during and after surgery and chemotherapy to enhance the clinical efficacy of adjuvant chemotherapy reduce the occurrence of adverse effects prevent metastasis and recurrence and ultimately improve survival rates
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None