Symptom relief by traditional Chinese medicine at a Chinese medicine ward for head and neck cancer patients undergoing radiotherapy
| ISRCTN | ISRCTN32748291 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32748291 |
| Secondary identifying numbers | N/A |
- Submission date
- 26/02/2016
- Registration date
- 01/03/2016
- Last edited
- 29/05/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
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
a12015@adm.cgmh.org.tw
Contact information
Scientific
123, Dinghu Rd
Jiolu Village
Gueishan Township
Taoyuan
333/886
Taiwan
 ORCID ID |
0000-0001-9719-1664 |
|---|
Study information
| Study design | Interventional non-randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The efficacy of integrated traditional Chinese medicine intervention at a Chinese medicine ward for head and neck cancer patients undergoing radiotherapy |
| Study hypothesis | Integrated traditional Chinese medicine intervention may reduce symptoms caused by radiation and provide better quality of life for head and neck cancer patients |
| Ethics approval(s) | Institutional Review Board of the Chang Gung Memorial Hospital in Taiwan, 21/01/2013~20/01/2015, No: 101-2802A3 |
| Condition | Acute toxicities post radiotherapy for head and neck cancers |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 01/02/2013 |
| Overall study end date | 20/01/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 for study group and 60 for control group |
| Total final enrolment | 131 |
| 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 |
| 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 | 11/03/2013 |
| Recruitment end date | 19/12/2014 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Taiwan
Sponsor information
Hospital/treatment centre
123, Dinghu Rd
Jiolu Village
Gueishan Township
Taoyuan
333/886
Taiwan
"ROR" |
https://ror.org/02verss31 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Currently we are preparing for submission of the paper to a journal |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2016 | 29/05/2020 | Yes | No |
Editorial Notes
29/05/2020: Publication reference and total final enrolment number added.
