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

October 24, 2022 updated by: China Medical University Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan, 404327
        • China Medical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The completion rate
Time Frame: 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.
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
Time Frame: The assessment is performed at the eighth week.
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
Time Frame: The questionnaire is assessed at the baseline and the eighth week.
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
Time Frame: The questionnaire is assessed at the baseline and the eighth week.
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
Time Frame: The lab data of biochemistry analysis is collected at the baseline and the eighth week.
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
Time Frame: The lab data of biochemistry analysis is collected at the baseline and the eighth week.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Investigators

  • Principal Investigator: Ming-Yu Lien, Ph.D, China Medical University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2018

Primary Completion (Actual)

June 14, 2020

Study Completion (Actual)

December 25, 2020

Study Registration Dates

First Submitted

October 16, 2022

First Submitted That Met QC Criteria

October 19, 2022

First Posted (Actual)

October 21, 2022

Study Record Updates

Last Update Posted (Actual)

October 26, 2022

Last Update Submitted That Met QC Criteria

October 24, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH106-REC3-149

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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