Plain English Summary
Background and study aims
The aim of this study is to investigate whether treatment with both traditional Chinese medicine and Western medicine alleviates the side effects of radiation treatment in head and neck cancer patients. This may help cancer patients to complete their treatment and improve their quality of life.
Who can participate?
Patients aged from 20 to 75, diagnosed with head and neck cancer, who are going to receive radiotherapy with or without chemotherapy.
What does the study involve?
The study group are admitted to the Chinese medicine ward of Chang Gung Memorial Hospital, Taoyuan, Taiwan, and receive integrated treatment of traditional Chinese medicine from the first week of radiotherapy till the end. The control group only receive conventional cancer treatment at the Radio-Oncology or Oncology outpatient department.
What are the possible benefits and risks of participating?
Participants in the study group may experience fewer side effects and better quality of life compared with conventional cancer treatment. There were no known side effects related to the Chinese medicine used in our ward.
Where is the study run from?
Chang Gung Memorial Hospital, Linkou, and Taoyuan branch (Taiwan)
When is the study starting and how long is it expected to run for?
February 2013 to January 2015
Who is funding the study?
Chang Gung Memorial Hospital (Taiwan)
Who is the main contact?
Dr Jiun-Liang Chen
Miss Peiyu Hsu
The efficacy of integrated traditional Chinese medicine intervention at a Chinese medicine ward for head and neck cancer patients undergoing radiotherapy
Integrated traditional Chinese medicine intervention may reduce symptoms caused by radiation and provide better quality of life for head and neck cancer patients
Institutional Review Board of the Chang Gung Memorial Hospital in Taiwan, 21/01/2013~20/01/2015, No: 101-2802A3
Interventional non-randomised study
Primary study design
Secondary study design
Non randomised study
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Acute toxicities post radiotherapy for head and neck cancers
Patients choose to be in the study group or the control group according to their wishes. The study group are admitted to the Chinese medicine ward, Chang Gung Memorial Hospital, Taoyuan, Taiwan, and receive integrated treatment of traditional Chinese medicine from the first week of radiotherapy till the end. The control group only receive conventional cancer treatments at the Radio-Oncology or Oncology outpatient department.
Both the study group and the control group receive conventional cancer therapy as surgery, radiation therapy or chemotherapy according to their disease status as usual.
Primary outcome measures
1. EORTC QLQ – H&N35 once per week since the second week of radiotherapy till the end
2. RTOG acute radiation morbidity scoring criteria measured at the first week, the fourth week and the end of radiotherapy
Secondary outcome measures
1. EORTC QLQ-C30 (version 3.0) measured at first, second, fourth and the end of radiotherapy
2. Body Constitution Questionanaire measured at first, second, fourth and the end of radiotherapy
3. Body weight per week since the first week of radiotherapy till the end
4. CBC/DC, AST, ALT, BUN, Cr, Albumin, High-sensitivity CRP, SCC of hospitalized patients at the beginning and the end of traditional Chinese medicine intervention
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Patients aged from 20 to 75 years old diagnosed with head and neck cancer and receiving radiotherapy with or without chemotherapy
2. Stable vital signs
3. Eastern Cooperative Oncology Group (ECOG) 0-2
Target number of participants
60 for study group and 60 for control group
Participant exclusion criteria
1. Cancer in terminal stage when aggressive treatments are not suitable
2. Unstable vital signs
3. ECOG performance ≧3
4. Impaired renal and liver function at initial diagnosis (including chronic kidney disease stage III, IV, V and AST, ALT ≧ 5ⅹupper normal limit)
5. Patients who have uncontrolled psychiatric problems or unclear consciousness
6. Patients who are receiving other Chinese medicine treatments
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Chang Gung Memorial Hospital, Linkou, and Taoyuan branch
Chang Gung Memorial Hospital (Taiwan)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Currently we are preparing for submission of the paper to a journal
Intention to publish date
Participant level data
Results - basic reporting