NCT03136575

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable head-and-neck-cancer

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 2, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

August 28, 2018

Status Verified

August 1, 2018

Enrollment Period

2.8 years

First QC Date

April 20, 2017

Last Update Submit

August 26, 2018

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (4)

  • 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

    before radiotherapy starts and after radiotherapy complete. (The duration of radiotherapy course is usually about 6 to 7 weeks)

  • 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)

    before radiotherapy start and after radiotherapy complete. (The duration of radiotherapy course is usually about 6 to 7 weeks)

  • Change of sleep quality

    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

    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)

Study Arms (2)

Qigong

ACTIVE COMPARATOR

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

wait-list control

PLACEBO COMPARATOR

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

Interventions

QigongBEHAVIORAL

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

Qigong
Wait-list controlBEHAVIORAL

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

wait-list control

Eligibility Criteria

Age20 Years - 65 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Details90% of head and neck cancer patients are male gender, so this study mainly includes male
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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

You may not qualify if:

  • \- Previous radiotherapy to head and neck region Patients who refused to sign the informed consents Patients who took antihypertensive drugs, sedatives, or antiarrhythmic drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsihung Medical University Hospital

Kaohsiung City, 80708, Taiwan

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Qigong

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Breathing ExercisesMind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Central Study Contacts

Pen-Tzu Fang, MD

CONTACT

886-7-3121101ptmonicafang@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
patients who signed inform consent are randomized into qigong group and wait-list control (WLC)
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2017

First Posted

May 2, 2017

Study Start

March 28, 2016

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

August 28, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)