The Impact of Qigong on Quality of Life and Sleep Disturbance in Head and Neck Patients Undergoing Radiotherapy

NCT ID: NCT03136575

Last Updated: 2018-08-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-28
• Study Completion Date: 2018-12-31

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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Qigong

Patients in the Qigong group receive Qigong,a mind-body exercise, 3 times a week, for 6 weeks during radiotherapy course. The participants are given a DVD contains Qigong program, and they attend the Qigong class in a health education room at the radiation oncology department to assure their attendance.

Group Type: ACTIVE_COMPARATOR

Qigong

Intervention Type: BEHAVIORAL

a 30 minutes exercise program, 3 times a week and lasts for 6 weeks during radiotherapy course

wait-list control

Patients who are assigned to the wait-list control are told to have some exercise by their own but no actually attend the the class in fact.

Group Type: PLACEBO_COMPARATOR

Wait-list control

Intervention Type: BEHAVIORAL

patients enrolled in this group are informed orally to have exercise only and are arranged in a waiting list

Interventions

Qigong

a 30 minutes exercise program, 3 times a week and lasts for 6 weeks during radiotherapy course

Intervention Type: BEHAVIORAL

Wait-list control

patients enrolled in this group are informed orally to have exercise only and are arranged in a waiting list

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Kaohsiung Medical University

OTHER

Sponsor Role: collaborator

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kaohsihung Medical University Hospital

Kaohsiung City, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Pen-Tzu Fang, MD

Role: CONTACT

ptmonicafang@gmail.com

886-7-3121101 ext. 7158

Facility Contacts

Pen-Tzu FANG, MD

Role: primary

ptmonicafang@gmail.com

886-7-3121101 ext. 7158

Other Identifiers

KMUHIRB-E(II)20150219

Identifier Type: -

Identifier Source: org_study_id