Chemoradiotherapy Clinical Trial
Official title:
A Pilot Study of Additional Chinese Formula for Concurrent Chemoradiotherapy in Oral Cavity Cancer Patients
Verified date | October 2022 |
Source | China Medical University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 21 |
Est. completion date | December 25, 2020 |
Est. primary completion date | June 14, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | China Medical University Hospital | Taichung |
Lead Sponsor | Collaborator |
---|---|
China Medical University Hospital |
Taiwan,
Adelstein DJ, Li Y, Adams GL, Wagner H Jr, Kish JA, Ensley JF, Schuller DE, Forastiere AA. An intergroup phase III comparison of standard radiation therapy and two schedules of concurrent chemoradiotherapy in patients with unresectable squamous cell head and neck cancer. J Clin Oncol. 2003 Jan 1;21(1):92-8. — View Citation
Bernier J, Cooper JS, Pajak TF, van Glabbeke M, Bourhis J, Forastiere A, Ozsahin EM, Jacobs JR, Jassem J, Ang KK, Lefèbvre JL. Defining risk levels in locally advanced head and neck cancers: a comparative analysis of concurrent postoperative radiation plus chemotherapy trials of the EORTC (#22931) and RTOG (# 9501). Head Neck. 2005 Oct;27(10):843-50. — View Citation
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Cooper JS, Zhang Q, Pajak TF, Forastiere AA, Jacobs J, Saxman SB, Kish JA, Kim HE, Cmelak AJ, Rotman M, Lustig R, Ensley JF, Thorstad W, Schultz CJ, Yom SS, Ang KK. Long-term follow-up of the RTOG 9501/intergroup phase III trial: postoperative concurrent radiation therapy and chemotherapy in high-risk squamous cell carcinoma of the head and neck. Int J Radiat Oncol Biol Phys. 2012 Dec 1;84(5):1198-205. doi: 10.1016/j.ijrobp.2012.05.008. Epub 2012 Jun 30. — View Citation
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Herrmann T, Jakubek A, Trott KR. The importance of the timing of a gap in radiotherapy of squamous cell carcinomas of the head and neck. Strahlenther Onkol. 1994 Sep;170(9):545-9. — View Citation
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Russo G, Haddad R, Posner M, Machtay M. Radiation treatment breaks and ulcerative mucositis in head and neck cancer. Oncologist. 2008 Aug;13(8):886-98. doi: 10.1634/theoncologist.2008-0024. Epub 2008 Aug 13. Review. — View Citation
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. |
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