Radiation-Induced Fibrosis in Patients With Head and Neck CancerNCT04850170

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

A study testing manual therapy and Speech therapy in people with Radiation-Induced Fibrosis in Patients With Head and Neck Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Radiation-Induced Fibrosis in Patients With Head and Neck Cancer
What is being tested?: manual therapy and Speech therapy
Type of treatment: Pill or oral medicine, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteTaiwan
Study dates: 1 Aug 2021to 31 Dec 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Tsung-Hsien Yang, MD contact

886-975-362-728

cgupanda@gmail.com

Taiwan1 site, 1 recruiting

New Taipei Municipal Tucheng Hospital
New Taipei City, 236
TsungHsien Yang, 886-975-362-728, cgupanda@gmail.com
Recruiting

Other trials in Taiwan

About 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.

Conditions: Radiation-Induced Fibrosis in Patients With Head and Neck Cancer
Being tested: manual therapy, Speech therapy
Keywords: Head and neck cancer, Post-radiation fibrosis, Manual therapy, Rehabilitation
Medical subject headings: Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

manual therapyProcedure or surgery
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.
Speech therapyProcedure or surgery
include the stretching of the neck, facial and oral movement training, and swallowing training

Study groups in NCT04850170
Study group	Role	What they receive
Experimental group	Experimental	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. Receives: Procedure: manual therapy; Procedure: Speech therapy
Control group	Active comparator	The control group will be arranged rehabilitation. Receives: Procedure: Speech therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (14)

range of motion, shoulder
to measure the degree of bilateral shoulder, including flexion, extension, abduction, adduction, external rotation, and internal rotation
Measured: 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
measure the maximum interincisal opening and range of the jaw and mouth
Measured: at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year
EORTC QLQ C30
the most widely used questionnaire for cancer patients; explore aspects of quality of life assessment, evaluation and interpretation.
Measured: at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year
EORTC H&N 35
questionnaire for head and neck cancer patients.
Measured: at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year
Numerical rating scale of pain
evaluate the pain degree(0~10); higher scores mean a worse outcome
Measured: at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year
Swallowing Video Fluoroscopy
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.
Measured: at baseline, the 6th month, and the 12th month
Change from Baseline range of motion, neck at the the 6th month
including neck flexion, extension, right and left lateral flexion, and lateral rotation
Measured: baseline and 6th month
Change from Baseline range of motion, neck at the the 12th month
including neck flexion, extension, right and left lateral flexion, and lateral rotation
Measured: baseline and 12th month
Change from Baseline range of motion, neck at the the 2nd year
including neck flexion, extension, right and left lateral flexion, and lateral rotation
Measured: baseline and 2nd year
Change from Baseline range of motion, neck at the the 3rd year
including neck flexion, extension, right and left lateral flexion, and lateral rotation
Measured: baseline and 3rd year
Change from Baseline Functional oral intake scales at 6th month
in this scales, the maximum values is grade seven, the minimum values is grade one. The higher scores mean a better outcome.
Measured: baseline and 6th month
Change from Baseline Functional oral intake scales at 12th month
in this scales, the maximum values is grade seven, the minimum values is grade one. The higher scores mean a better outcome.
Measured: baseline and 12th month
Change from Baseline Functional oral intake scales at 2nd year
in this scales, the maximum values is grade seven, the minimum values is grade one. The higher scores mean a better outcome.
Measured: baseline and 2nd year
Change from Baseline Functional oral intake scales at 3rd year
in this scales, the maximum values is grade seven, the minimum values is grade one. The higher scores mean a better outcome.
Measured: baseline and 3rd year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 202131 Dec 2025

First posted20 Apr 2021
Study start1 Aug 2021
Primary completion31 Dec 2023 (estimated)
Study completion31 Dec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Radiation-Induced Fibrosis in Patients With Head and Neck CancerStudies of the same condition, open and under way.
More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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 now. 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).
Masking: None (open label)
Enrolment: 70 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04850170
Sponsor's protocol ID: 202002052A3
Other IDs: CMRPVVL0081
Status last verified: Apr 2021
First submitted: 12 Apr 2021
Last updated: 11 Mar 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Wang B, Wei J, Meng L, Wang H, Qu C, Chen X, Xin Y, Jiang X. Advances in pathogenic mechanisms and management of radiation-induced fibrosis. Biomed Pharmacother. 2020 Jan;121:109560. doi: 10.1016/j.biopha.2019.109560. Epub 2019 Nov 15.
PubMed 31739160
Purkayastha A, Sharma N, Sarin A, Bhatnagar S, Chakravarty N, Mukundan H, Suhag V, Singh S. Radiation Fibrosis Syndrome: the Evergreen Menace of Radiation Therapy. Asia Pac J Oncol Nurs. 2019 Jul-Sep;6(3):238-245. doi: 10.4103/apjon.apjon_71_18.
PubMed 31259219
Hojan K, Milecki P. Opportunities for rehabilitation of patients with radiation fibrosis syndrome. Rep Pract Oncol Radiother. 2013 Aug 8;19(1):1-6. doi: 10.1016/j.rpor.2013.07.007. eCollection 2014 Jan.
PubMed 24936313
Moloney EC, Brunner M, Alexander AJ, Clark J. Quantifying fibrosis in head and neck cancer treatment: An overview. Head Neck. 2015 Aug;37(8):1225-31. doi: 10.1002/hed.23722. Epub 2014 Jul 11.
PubMed 24797251
Davis AM, Dische S, Gerber L, Saunders M, Leung SF, O'Sullivan B. Measuring postirradiation subcutaneous soft-tissue fibrosis: state-of-the-art and future directions. Semin Radiat Oncol. 2003 Jul;13(3):203-13. doi: 10.1016/S1053-4296(03)00022-5.
PubMed 12903010
Raj VS, Pugh TM, Yaguda SI, Mitchell CH, Mullan SS, Garces NS. The Who, What, Why, When, Where, and How of Team-Based Interdisciplinary Cancer Rehabilitation. Semin Oncol Nurs. 2020 Feb;36(1):150974. doi: 10.1016/j.soncn.2019.150974. Epub 2020 Jan 16.
PubMed 31955923
Krisciunas GP, Vakharia A, Lazarus C, Taborda SG, Martino R, Hutcheson K, McCulloch T, Langmore SE. Application of Manual Therapy for Dysphagia in Head and Neck Cancer Patients: A Preliminary National Survey of Treatment Trends and Adverse Events. Glob Adv Health Med. 2019 Apr 24;8:2164956119844151. doi: 10.1177/2164956119844151. eCollection 2019.
PubMed 31041144
Krisciunas GP, Golan H, Marinko LN, Pearson W, Jalisi S, Langmore SE. A novel manual therapy programme during radiation therapy for head and neck cancer - our clinical experience with five patients. Clin Otolaryngol. 2016 Aug;41(4):425-31. doi: 10.1111/coa.12535. Epub 2016 Feb 8. No abstract available.
PubMed 26381894

Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Evaluation of Manual Therapy for the Prevention of Radiation-Induced Fibrosis in Patients With Head and Neck Cancer
ClinicalTrials.gov ID: NCT04850170
Acronym / sponsor ID: 202002052A3
Conditions: Radiation-Induced Fibrosis in Patients With Head and Neck Cancer
Keywords: Head and neck cancer, Post-radiation fibrosis, Manual therapy, Rehabilitation
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 70 participants (estimated)
Lead sponsor: Chang Gung Memorial HospitalUniversity, hospital or other
Study start: 1 Aug 2021 (actual)
Primary completion: 31 Dec 2023 (estimated)
Study completion: 31 Dec 2025 (estimated)
First posted: 20 Apr 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: 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 now. 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).

Arm	Type	Receives
Experimental group	Experimental	Procedure: manual therapy, Procedure: Speech therapyThe 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.
Control group	Active comparator	Procedure: Speech therapyThe control group will be arranged rehabilitation.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
manual therapy1. 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 or surgery	Experimental group
Speech therapyinclude the stretching of the neck, facial and oral movement training, and swallowing training	Procedure or surgery	Control group, Experimental group

Primary outcome

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
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.

14 secondary outcomes

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
Width of mouth opening
Time frame: 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
EORTC H&N 35
Time frame: 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
Swallowing Video Fluoroscopy
Time frame: 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
Change from Baseline range of motion, neck at the the 12th month
Time frame: baseline and 12th month
Change from Baseline range of motion, neck at the the 2nd year
Time frame: baseline and 2nd year
Change from Baseline range of motion, neck at the the 3rd year
Time frame: baseline and 3rd year
Change from Baseline Functional oral intake scales at 6th month
Time frame: baseline and 6th month
Change from Baseline Functional oral intake scales at 12th month
Time frame: baseline and 12th month
Change from Baseline Functional oral intake scales at 2nd year
Time frame: baseline and 2nd year
Change from Baseline Functional oral intake scales at 3rd year
Time frame: baseline and 3rd year

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
Background: PubMed 31739160Wang B, Wei J, Meng L, Wang H, Qu C, Chen X, Xin Y, Jiang X. Advances in pathogenic mechanisms and management of radiation-induced fibrosis. Biomed Pharmacother. 2020 Jan;121:109560. doi: 10.1016/j.biopha.2019.109560. Epub 2019 Nov 15.
Background: PubMed 31259219Purkayastha A, Sharma N, Sarin A, Bhatnagar S, Chakravarty N, Mukundan H, Suhag V, Singh S. Radiation Fibrosis Syndrome: the Evergreen Menace of Radiation Therapy. Asia Pac J Oncol Nurs. 2019 Jul-Sep;6(3):238-245. doi: 10.4103/apjon.apjon_71_18.
Background: PubMed 24936313Hojan K, Milecki P. Opportunities for rehabilitation of patients with radiation fibrosis syndrome. Rep Pract Oncol Radiother. 2013 Aug 8;19(1):1-6. doi: 10.1016/j.rpor.2013.07.007. eCollection 2014 Jan.
Background: PubMed 24797251Moloney EC, Brunner M, Alexander AJ, Clark J. Quantifying fibrosis in head and neck cancer treatment: An overview. Head Neck. 2015 Aug;37(8):1225-31. doi: 10.1002/hed.23722. Epub 2014 Jul 11.
Background: PubMed 12903010Davis AM, Dische S, Gerber L, Saunders M, Leung SF, O'Sullivan B. Measuring postirradiation subcutaneous soft-tissue fibrosis: state-of-the-art and future directions. Semin Radiat Oncol. 2003 Jul;13(3):203-13. doi: 10.1016/S1053-4296(03)00022-5.
Background: PubMed 31955923Raj VS, Pugh TM, Yaguda SI, Mitchell CH, Mullan SS, Garces NS. The Who, What, Why, When, Where, and How of Team-Based Interdisciplinary Cancer Rehabilitation. Semin Oncol Nurs. 2020 Feb;36(1):150974. doi: 10.1016/j.soncn.2019.150974. Epub 2020 Jan 16.
Background: PubMed 31041144Krisciunas GP, Vakharia A, Lazarus C, Taborda SG, Martino R, Hutcheson K, McCulloch T, Langmore SE. Application of Manual Therapy for Dysphagia in Head and Neck Cancer Patients: A Preliminary National Survey of Treatment Trends and Adverse Events. Glob Adv Health Med. 2019 Apr 24;8:2164956119844151. doi: 10.1177/2164956119844151. eCollection 2019.
Background: PubMed 26381894Krisciunas GP, Golan H, Marinko LN, Pearson W, Jalisi S, Langmore SE. A novel manual therapy programme during radiation therapy for head and neck cancer - our clinical experience with five patients. Clin Otolaryngol. 2016 Aug;41(4):425-31. doi: 10.1111/coa.12535. Epub 2016 Feb 8. No abstract available.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tsung-Hsien Yang, MD contact

886-975-362-728

cgupanda@gmail.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing manual therapy and Speech therapy in people with Radiation-Induced Fibrosis in Patients With Head and Neck Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tsung-Hsien Yang, MD (886-975-362-728, cgupanda@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline range of motion, neck at the 3rd month (time frame: baseline and 3rd month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04850170, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.