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

• ClinicalTrials.gov Identifier: NCT04850170
• Recruitment Status: Recruiting
• First Posted: April 20, 2021
• Last Update Posted: March 11, 2022
• Sponsor: Chang Gung Memorial Hospital
• Information provided by (Responsible Party): Chang Gung Memorial Hospital

Tracking Information

• First Submitted Date: April 12, 2021
• First Posted Date: April 20, 2021
• Last Update Posted Date: March 11, 2022
• Actual Study Start Date: August 1, 2021
• Estimated Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 19, 2021)

• 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 19, 2021)

• 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
• 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
• 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.
• 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.
• 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
• 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.
• 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
• 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
• 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
• 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
• 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.
• 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.
• 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.
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Evaluation of Manual Therapy for the Prevention of Radiation-Induced Fibrosis in Patients With Head and Neck Cancer
• Official Title: The Evaluation of Manual Therapy for the Prevention of Radiation-Induced Fibrosis in Patients With Head and Neck Cancer

Brief 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. 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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Prevention

• Condition: Radiation-Induced Fibrosis in Patients With Head and Neck Cancer

Intervention

• 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

Study Arms

• 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.

  Interventions:

  • Procedure: manual therapy
  • Procedure: Speech therapy
• Active Comparator: Control group
  The control group will be arranged rehabilitation.
  Intervention: Procedure: Speech therapy

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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 19, 2021): 70
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2025
• Estimated Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Tsung-Hsien Yang, MD; 886-975-362-728; cgupanda@gmail.com

• Listed Location Countries: Taiwan

Administrative Information

• NCT Number: NCT04850170
• Other Study ID Numbers: 202002052A3; CMRPVVL0081 ( Other Grant/Funding Number: Chang Gung memorial hospital )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Chang Gung Memorial Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Chang Gung Memorial Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Chang Gung Memorial Hospital
• Verification Date: April 2021