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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Head and Neck Neoplasm, Chemoradiotherapy

Intervention / Treatment
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* Drug: SZKJT(San-Zhong-Kui-Jian-Tang)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged from 20- to 65-year-old; firstly diagnosed as head and neck cancer with stage II, III or IV; adjuvant therapy with chemotherapy of Cisplatin or combined with radiotherapy after surgery; or chemotherapy of Cisplatin for those without surgery; wiliness to sign inform consent. Exclusion Criteria: pregnancy; non-Squamous-cell carcinoma; secondary cancer or Carcinoma in situ in 5 years; any evidence of metastasis; abnormality of liver, kidney or bone marrow functions before treatments; unstable vital signs; episode of acute infection; unclear consciousness for inform consent; receiving other herbal, complementary or acupuncture therapy.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SZKJT group<br>Patients who meet the inclusion criteria and agree to receive concomitant treatment with SZKJT. | Drug: SZKJT(San-Zhong-Kui-Jian-Tang)<br>* The SZKJT samples were made and packed by Kaiser Pharmaceutical Co. Ltd. with lot number of 2019023247.<br>* Other names: Product from Kaiser Pharmaceutical Co. Ltd.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The completion rate | We counted the percentage rate of those who achieved and did not reach the CCRT course. | We will do an assessment at the seventh week of CCRT. Patients who had completed a seven-week course of treatment and had a cumulative dose of cisplatin greater than 200 mg per m2 will be considered the completion group. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The adverse effects | We apply Common Terminology Criteria for Adverse Events (CTCAE) to assess the adverse effects of CCRT. | The assessment is performed at the eighth week. | 
| The change in Quality of Life | We assess the patients' quality of life by using the European Organisation for Research and Treatment of Cancer (EORTC) quality-of-life questionnaire QLQ-C30. | The questionnaire is assessed at the baseline and the eighth week. | 
| The Change of Constitutions of traditional Chinese medicine | We assess the patients' constitutions of traditional Chinese medicine by using Body Constitution Questionnaire (BCQ). | The questionnaire is assessed at the baseline and the eighth week. | 
| The change of liver function | We monitor the liver function of the patients by blood chemistry analysis. The levels of Alanine transaminase (ALT) and Aspartate transaminase (AST) are recorded as units per liter. | The lab data of biochemistry analysis is collected at the baseline and the eighth week. | 
| The change of renal function | We monitor the renal function of the patients by blood chemistry analysis. The levels of blood urine nitrogen (mg/dL) and creatinine (mg/dL) are recorded. Glomerular filtration rate (GFR) is estimated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation (2021). | The lab data of biochemistry analysis is collected at the baseline and the eighth week. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Head and Neck Neoplasms;, Chemoradiotherapy, Complementary Therapies, Medicine, Chinese Traditional