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

• Status: Completed
• Trial end date: 2020-12-25
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China Medical University Hospital

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.