The Evaluation of Manual Therapy for the Prevention of Radiation-Induced Fibrosis in Patients With Head and Neck Cancer

March 9, 2022 updated by: Chang Gung Memorial Hospital

The subjects in this study are the patients with head and neck cancer after completion of the radiotherapy. Radiation-induced fibrosis is inevitable and there is no effective treatment to prevent it. Therefore, there are two parts in this study :

The first part is a pilot study. There will be 10 subjects included and manual therapy and rehabilitation will be arranged for 6 months. The manual therapy would be once a week at most, and the rehabilitation would be twice a week at most.

The second part is a randomized controlled study. 60 patients would be randomized divided into two groups. The group 1 is manual therapy(once a week at most) and rehabilitation(twice a week at most), and the group 2 is rehabilitation only(twice a week at most). Patients would be evaluated at baseline, 3rd, 6th, and 12th month. The evaluation is including the degree of superficial soft tissue fibrosis, numerical rating scale of pain, range of motion(neck), range of motion(shoulder), width of mouth opening, EORTC QLQ C30, EORTC QLQ H&N 35, and functional oral intake scale. Besides, swallowing video fluoroscopy would be done at baseline, 6th, and 12th month.

When the subject completes the evaluation in the 12th month, the study is ended.

Because the radiation-induced fibrosis is progressed with time, we will follow up the condition of subjects at the next year and the following third year.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

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 Contact

Study Locations

  • Taiwan
      • New Taipei City, Taiwan, 236
        • Recruiting
        • New Taipei Municipal TuCheng Hospital
        • Contact:

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria :

  1. Age > 20 years
  2. Head and neck cancer
  3. After Completion of radiation therapy for 4 to 6 weeks
  4. Be willing to accept manual therapy and long-term follow up

Exclusion Criteria :

  1. Recurrence, metastatic cancer, or concurrent second cancer
  2. With post-radiation dermatitis at neck or shoulder
  3. Current pregnancy or lactation
  4. Life expectancy of < 12 months.

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group

The first ten subjects will be enrolled in a pilot study. The following sixty subjects will be separated randomly to experimental group and control group.

The first ten subjects and the experimental group will be arranged manual therapy and rehabilitation for six months.
Procedure: manual therapy
  1. release and stretch the muscles and fascia around shoulder girdle、upper arm and forearm;
  2. massage the masseter muscle and temporalis muscle;
  3. mobilization of the temporomandibular joint, the thoracic and cervical spine, shoulder, and elbow.
Procedure: Speech therapy
include the stretching of the neck, facial and oral movement training, and swallowing training
Active Comparator: Control group
The control group will be arranged rehabilitation.
Procedure: Speech therapy
include the stretching of the neck, facial and oral movement training, and swallowing training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline range of motion, neck at the 3rd month
Time Frame: baseline and 3rd month
including neck flexion, extension, right and left lateral flexion, and lateral rotation
baseline and 3rd month
Change from Baseline Functional oral intake scales at 3rd month
Time Frame: baseline and 3rd month
in this scales, the maximum values is grade seven, the minimum values is grade one. The higher scores mean a better outcome.
baseline and 3rd month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
range of motion, shoulder
Time Frame: measure the range of motion at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year
to measure the degree of bilateral shoulder, including flexion, extension, abduction, adduction, external rotation, and internal rotation
measure the range of motion at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year
Width of mouth opening
Time Frame: at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year
measure the maximum interincisal opening and range of the jaw and mouth
at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year
EORTC QLQ C30
Time Frame: at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year
the most widely used questionnaire for cancer patients; explore aspects of quality of life assessment, evaluation and interpretation.
at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year
EORTC H&N 35
Time Frame: at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year
questionnaire for head and neck cancer patients.
at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year
Numerical rating scale of pain
Time Frame: at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year
evaluate the pain degree(0~10); higher scores mean a worse outcome
at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year
Swallowing Video Fluoroscopy
Time Frame: at baseline, the 6th month, and the 12th month
Observe that the patient swallows items with different thicknesses and textures via using a special real-time form of x-ray. This examination allows us to test the ability to swallow safely and effectively.
at baseline, the 6th month, and the 12th month
Change from Baseline range of motion, neck at the the 6th month
Time Frame: baseline and 6th month
including neck flexion, extension, right and left lateral flexion, and lateral rotation
baseline and 6th month
Change from Baseline range of motion, neck at the the 12th month
Time Frame: baseline and 12th month
including neck flexion, extension, right and left lateral flexion, and lateral rotation
baseline and 12th month
Change from Baseline range of motion, neck at the the 2nd year
Time Frame: baseline and 2nd year
including neck flexion, extension, right and left lateral flexion, and lateral rotation
baseline and 2nd year
Change from Baseline range of motion, neck at the the 3rd year
Time Frame: baseline and 3rd year
including neck flexion, extension, right and left lateral flexion, and lateral rotation
baseline and 3rd year
Change from Baseline Functional oral intake scales at 6th month
Time Frame: baseline and 6th month
in this scales, the maximum values is grade seven, the minimum values is grade one. The higher scores mean a better outcome.
baseline and 6th month
Change from Baseline Functional oral intake scales at 12th month
Time Frame: baseline and 12th month
in this scales, the maximum values is grade seven, the minimum values is grade one. The higher scores mean a better outcome.
baseline and 12th month
Change from Baseline Functional oral intake scales at 2nd year
Time Frame: baseline and 2nd year
in this scales, the maximum values is grade seven, the minimum values is grade one. The higher scores mean a better outcome.
baseline and 2nd year
Change from Baseline Functional oral intake scales at 3rd year
Time Frame: baseline and 3rd year
in this scales, the maximum values is grade seven, the minimum values is grade one. The higher scores mean a better outcome.
baseline and 3rd year

Collaborators and Investigators

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

Sponsor

Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 1, 2021

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

April 12, 2021

First Submitted That Met QC Criteria

April 19, 2021

First Posted (Actual)

April 20, 2021

Study Record Updates

Last Update Posted (Actual)

March 11, 2022

Last Update Submitted That Met QC Criteria

March 9, 2022

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202002052A3
  • CMRPVVL0081 (Other Grant/Funding Number: Chang Gung memorial hospital)

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.

Clinical Trials on Radiation-Induced Fibrosis in Patients With Head and Neck Cancer

Clinical Trials on manual therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe