Head and Neck Cancer
Conditions
Brief summary
This study aimed to observe how a six week qigong program influence patients with head and neck cancer during active radiotherapy treatment course. The quality of life, sleep dysfunction or depression and shoulder and neck function will be accessed by questionnaire, and ANS function will be objectively investigated using heart rate variability measurement.
Detailed description
The incidence of head and neck cancers is the 6th in Taiwan, and head and neck cancers are the 5th leading cause of cancer death, causing approximately 2000 death in 2010. Head and neck cancers patients usually require multimodality treatments, including surgery, chemotherapy and radiotherapy. These treatments can cause functional deterioration and worsened quality of life during or after the treatment, and bring tremendous effects on patient's life. When radiotherapy is indicated, it requires 6 to 7 weeks treatment, and most patients suffered from different degrees of mucositis, dermatitis, xerostomia and neck and shoulder tightness during radiotherapy. How to improve quality of life for these patients during radiotherapy is an important task. Qigong is a mind-body exercise or therapy; it can improve quality of life, such as fatigue, sleep dysfunction and depression through regulation of breath and simple physical exercise. Some found that the qigong can decrease inflammation and show some impact on accommodation of ANS in cancer patients. Most studies focus on how qigong effect on cancer survivors, however, this study is aimed to observe how a six week qigong program influence patients with head and neck cancer during active radiotherapy treatment course. The quality of life, sleep dysfunction or depression and shoulder and neck function will be accessed by questionnaire, and ANS function will be objectively investigated using heart rate variability measurement.
Interventions
BEHAVIORALQigong
a 30 minutes exercise program, 3 times a week and lasts for 6 weeks during radiotherapy course
BEHAVIORALWait-list control
patients enrolled in this group are informed orally to have exercise only and are arranged in a waiting list
Sponsors
Kaohsiung Medical University
Kaohsiung Medical University Chung-Ho Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
patients who signed inform consent are randomized into qigong group and wait-list control (WLC)
Intervention model description
randomized controlled trial
Eligibility
Sex/Gender
MALE
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
\- Clinical diagnosis of Head and neck squamous cell carcinoma, subsites including nasopharyngeal cancer, oropharyngeal cancer, oral cancer, hypopharyngeal cancer and laryngeal cancer Performance status ECOG 0-1 Physically able to participate in the qigong program
Exclusion criteria
\- Previous radiotherapy to head and neck region Patients who refused to sign the informed consents Patients who took antihypertensive drugs, sedatives, or antiarrhythmic drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of quality of life | before radiotherapy starts and after radiotherapy complete. (The duration of radiotherapy course is usually about 6 to 7 weeks) | The changes of quality of life before radiotherapy and after radiotherapy complete are evaluated using University of Washington Quality of Life Questionnaire (UW-QOL) to access the quality of life |
| Change of depression and anxiety | before radiotherapy start and after radiotherapy complete. (The duration of radiotherapy course is usually about 6 to 7 weeks) | The changes of the level of depression and anxiety before radiotherapy and after radiotherapy complete are accessed using hospital anxiety and depression scale (HADS) |
| Change of sleep quality | before radiotherapy start and after radiotherapy complete (The duration of radiotherapy course is usually about 6 to 7 weeks) | The change of sleep quality is evaluated using Pittsburgh Sleep Quality Index (PSQI) |
| Change of Autonomic nervous system (ANS) function | before radiotherapy start and after radiotherapy complete(The duration of radiotherapy course is usually about 6 to 7 weeks) | The change of ANS function is accessed by heart rate variability |
Countries
Taiwan
Contacts
Primary ContactPen-Tzu Fang, MD
Outcome results
None listed