Clinical trial NCT05590650: A Pilot Study of Additional Chinese Formula for Concurrent Chemoradiotherapy in Oral Cavity Cancer Patients
Official title: A Pilot Study of Additional Chinese Formula for Concurrent Chemoradiotherapy in Oral Cavity Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Head and Neck Neoplasm
Chemoradiotherapy
Keywords: Head and Neck Neoplasms;
Chemoradiotherapy
Complementary Therapies
Medicine, Chinese Traditional
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 21
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: The completion rate
timeFrame: 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:
measure: The adverse effects
timeFrame: The assessment is performed at the eighth week.
measure: The change in Quality of Life
timeFrame: The questionnaire is assessed at the baseline and the eighth week.
measure: The Change of Constitutions of traditional Chinese medicine
timeFrame: The questionnaire is assessed at the baseline and the eighth week.
measure: The change of liver function
timeFrame: The lab data of biochemistry analysis is collected at the baseline and the eighth week.
measure: The change of renal function
timeFrame: The lab data of biochemistry analysis is collected at the baseline and the eighth week.
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University Hospital
name: Ming-Yu Lien, Ph.D
role: PRINCIPAL_INVESTIGATOR
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