Condition category
Cancer
Date applied
26/02/2016
Date assigned
01/03/2016
Last edited
01/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Miss Peiyu Hsu

ORCID ID

http://orcid.org/0000-0001-9719-1664

Contact details

123
Dinghu Rd
Jiolu Village
Gueishan Township
Taoyuan
333/886
Taiwan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The efficacy of integrated traditional Chinese medicine intervention at a Chinese medicine ward for head and neck cancer patients undergoing radiotherapy

Acronym

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

Institutional Review Board of the Chang Gung Memorial Hospital in Taiwan, 21/01/2013~20/01/2015, No: 101-2802A3

Study design

Interventional non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Drug names

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

01/02/2013

Overall trial end date

20/01/2015

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

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

11/03/2013

Recruitment end date

19/12/2014

Locations

Countries of recruitment

Taiwan

Trial participating centre

Chang Gung Memorial Hospital, Linkou, and Taoyuan branch
886
Taiwan

Sponsor information

Organisation

Chang Gung Memorial Hospital (Taiwan)

Sponsor details

123
Dinghu Rd
Jiolu Village
Gueishan Township
Taoyuan
333/886
Taiwan

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Chang Gung Memorial Hospital (Taiwan)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes