Clinical trial NCT03136575: The Impact of Qigong on Quality of Life and Sleep Disturbance in Head and Neck Patients Undergoing Radiotherapy
Official title: The Impact of the Digital Traditional Qigong Regimen Exercises on Quality of Life and Sleep Disturbance in Head and Neck Patients Undergoing Radiotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Head and Neck Cancer
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Kaohsiung Medical University
First posted: 2017-05-02
Enrollment: 60
Sex: MALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of quality of life
timeFrame: before radiotherapy starts and after radiotherapy complete. (The duration of radiotherapy course is usually about 6 to 7 weeks)
measure: Change of depression and anxiety
timeFrame: before radiotherapy start and after radiotherapy complete. (The duration of radiotherapy course is usually about 6 to 7 weeks)
measure: Change of sleep quality
timeFrame: before radiotherapy start and after radiotherapy complete (The duration of radiotherapy course is usually about 6 to 7 weeks)
measure: Change of Autonomic nervous system (ANS) function
timeFrame: before radiotherapy start and after radiotherapy complete(The duration of radiotherapy course is usually about 6 to 7 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsihung Medical University Hospital
Study officials:
References: