search
Back to results

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

Primary Purpose

Head and Neck Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Qigong
Wait-list control
Sponsored by
Kaohsiung Medical University Chung-Ho Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Head and Neck Cancer

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Kaohsihung Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Qigong

wait-list control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change of quality of life
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
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
The change of sleep quality is evaluated using Pittsburgh Sleep Quality Index (PSQI)
Change of Autonomic nervous system (ANS) function
The change of ANS function is accessed by heart rate variability

Secondary Outcome Measures

Full Information

First Posted
April 20, 2017
Last Updated
August 26, 2018
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Collaborators
Kaohsiung Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT03136575
Brief Title
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

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 28, 2016 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Collaborators
Kaohsiung Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial
Masking
Participant
Masking Description
patients who signed inform consent are randomized into qigong group and wait-list control (WLC)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Qigong
Arm Type
Active Comparator
Arm Description
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.
Arm Title
wait-list control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Qigong
Intervention Description
a 30 minutes exercise program, 3 times a week and lasts for 6 weeks during radiotherapy course
Intervention Type
Behavioral
Intervention Name(s)
Wait-list control
Intervention Description
patients enrolled in this group are informed orally to have exercise only and are arranged in a waiting list
Primary Outcome Measure Information:
Title
Change of quality of life
Description
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
Time Frame
before radiotherapy starts and after radiotherapy complete. (The duration of radiotherapy course is usually about 6 to 7 weeks)
Title
Change of depression and anxiety
Description
The changes of the level of depression and anxiety before radiotherapy and after radiotherapy complete are accessed using hospital anxiety and depression scale (HADS)
Time Frame
before radiotherapy start and after radiotherapy complete. (The duration of radiotherapy course is usually about 6 to 7 weeks)
Title
Change of sleep quality
Description
The change of sleep quality is evaluated using Pittsburgh Sleep Quality Index (PSQI)
Time Frame
before radiotherapy start and after radiotherapy complete (The duration of radiotherapy course is usually about 6 to 7 weeks)
Title
Change of Autonomic nervous system (ANS) function
Description
The change of ANS function is accessed by heart rate variability
Time Frame
before radiotherapy start and after radiotherapy complete(The duration of radiotherapy course is usually about 6 to 7 weeks)

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
90% of head and neck cancer patients are male gender, so this study mainly includes male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pen-Tzu Fang, MD
Phone
886-7-3121101
Ext
7158
Email
ptmonicafang@gmail.com
Facility Information:
Facility Name
Kaohsihung Medical University Hospital
City
Kaohsiung
ZIP/Postal Code
80708
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pen-Tzu FANG, MD
Phone
886-7-3121101
Ext
7158
Email
ptmonicafang@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs