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

NCT ID: NCT05590650

Last Updated: 2022-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-07
• Study Completion Date: 2020-12-25

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

SZKJT group

Patients who meet the inclusion criteria and agree to receive concomitant treatment with SZKJT.

Group Type: EXPERIMENTAL

SZKJT(San-Zhong-Kui-Jian-Tang)

Intervention Type: DRUG

The SZKJT samples were made and packed by Kaiser Pharmaceutical Co. Ltd. with lot number of 2019023247.

Interventions

SZKJT(San-Zhong-Kui-Jian-Tang)

The SZKJT samples were made and packed by Kaiser Pharmaceutical Co. Ltd. with lot number of 2019023247.

Intervention Type: DRUG

Other Intervention Names

Product from Kaiser Pharmaceutical Co. Ltd.

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ming-Yu Lien, Ph.D

Role: PRINCIPAL_INVESTIGATOR

China Medical University Hospital

Locations

China Medical University Hospital

Taichung, , Taiwan

Countries

Taiwan

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Other Identifiers

CMUH106-REC3-149

Identifier Type: -

Identifier Source: org_study_id