NCT05590650

A Pilot Study of Additional Chinese Formula for Concurrent Chemoradiotherapy in Oral Cavity Cancer Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: China Medical University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn about the clinical efficacy of San-Zhong-Kui-Jian-Tang (SZKJT), a formula of Chinese medicine in head and neck cancer patients receiving concurrent chemoradiotherapy (CCRT) treatments. The main questions it aims to answer are: * Can SZKJT improve the completion rate of CCRT? * Can SZKJT reduce the adverse effects of CCRT? * How SZKJT affect the quality of life in the patients receiving CCRT * How about the safety of using SZKJT in the patients receiving CCRT Participants will be asked to: * take SZKJT for 9 weeks during the whole CCRT course * take questionnaires of quality of life

Detailed description

San-Zhong-Kui-Jian-Tang (SZKJT) is originated from the Secret Treasure of the Orchid Chamber written by Gao Li (AC1180 - 1251). SZKJT contains 16 herbs to treat abnormal swelling or nodules. In the theory of Chinese medicine, SZKJT can clear heat and resolve toxin, which leads to disperse swelling and binds in nodules. The purpose of this study is to explore the clinical efficacy and safety of SZKJT in improving the completion rate of concurrent chemoradiotherapy (CCRT) in patients with head and neck cancer, and to evaluate the prevention and treatment effects of SZKJT on the side effects of chemoradiotherapy, as well as the improvement of quality of life. The primary endpoint of the study is the completion rate of CCRT under SZKJT treatment. The secondary endpoints are adverse effects of CTCAE, body constitution questionnaire (BCQ) and the EORTC core quality of life questionnaire (QLQ-C30). Liver and kidney functions are considered as well for adverse effects of SZKJT. We hypothesized that additional SZKJT with CCRT might improve completion rate of CCRT and reduce severity of adverse effects of CCRT.

Conditions

• Head and Neck Neoplasm
• Chemoradiotherapy

Interventions

Type	Name	Description
DRUG	SZKJT(San-Zhong-Kui-Jian-Tang)	The SZKJT samples were made and packed by Kaiser Pharmaceutical Co. Ltd. with lot number of 2019023247.

Timeline

• Start date: 2018-07-07
• Primary completion: 2020-06-14
• Completion: 2020-12-25
• First posted: 2022-10-21
• Last updated: 2022-10-26

Locations

1 site across 1 country: Taiwan