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

August 26, 2018 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital

The Impact of the Digital Traditional Qigong Regimen Exercises on Quality of Life and Sleep Disturbance in Head and Neck Patients Undergoing Radiotherapy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 80708
        • Recruiting
        • Kaohsihung Medical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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.
Behavioral: Qigong
a 30 minutes exercise program, 3 times a week and lasts for 6 weeks during radiotherapy course
PLACEBO_COMPARATOR: 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.
Behavioral: Wait-list control
patients enrolled in this group are informed orally to have exercise only and are arranged in a waiting list

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of quality of life
Time Frame: 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
before radiotherapy starts and after radiotherapy complete. (The duration of radiotherapy course is usually about 6 to 7 weeks)
Change of depression and anxiety
Time Frame: 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)
before radiotherapy start and after radiotherapy complete. (The duration of radiotherapy course is usually about 6 to 7 weeks)
Change of sleep quality
Time Frame: 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)
before radiotherapy start and after radiotherapy complete (The duration of radiotherapy course is usually about 6 to 7 weeks)
Change of Autonomic nervous system (ANS) function
Time Frame: 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
before radiotherapy start and after radiotherapy complete(The duration of radiotherapy course is usually about 6 to 7 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Collaborators

Kaohsiung Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 28, 2016

Primary Completion (ANTICIPATED)

December 31, 2018

Study Completion (ANTICIPATED)

December 31, 2018

Study Registration Dates

First Submitted

April 20, 2017

First Submitted That Met QC Criteria

April 27, 2017

First Posted (ACTUAL)

May 2, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 28, 2018

Last Update Submitted That Met QC Criteria

August 26, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMUHIRB-E(II)20150219

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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