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

NCT05590650 | Completed Phase 1 DMC

• 1 other identifier: CMUH106-REC3-149
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Conditions

Head and Neck Neoplasm; Chemoradiotherapy

Keywords

Head and Neck Neoplasms;; Chemoradiotherapy; Complementary Therapies; Medicine, Chinese Traditional

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The adverse effects

  The assessment is performed at the eighth week.

• The change in Quality of Life

  The questionnaire is assessed at the baseline and the eighth week.

• The Change of Constitutions of traditional Chinese medicine

  The questionnaire is assessed at the baseline and the eighth week.

• The change of liver function

  The lab data of biochemistry analysis is collected at the baseline and the eighth week.

• The change of renal function

  The lab data of biochemistry analysis is collected at the baseline and the eighth week.

Study Arms (1)

SZKJT group

EXPERIMENTAL

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

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

Interventions

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

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

Also known as: Product from Kaiser Pharmaceutical Co. Ltd.

SZKJT group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, 404327, Taiwan

Location

Related Publications (15)

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  PMID: 40123292 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Ming-Yu Lien, Ph.D

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2022
• First Posted: October 21, 2022
• Study Start: July 7, 2018
• Primary Completion: June 14, 2020
• Study Completion: December 25, 2020
• Last Updated: October 26, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)