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

NCT04850170 | Unknown DMC

• 2 other identifiers: 202002052A3CMRPVVL0081
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation-Induced Fibrosis in Patients With Head and Neck Cancer

Keywords

Head and neck cancer; Post-radiation fibrosis; Manual therapy; Rehabilitation

Outcome Measures

Primary Outcomes (2)

• Change from Baseline range of motion, neck at the 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

  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 Outcomes (14)

• range of motion, shoulder

  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

  at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year

• EORTC QLQ C30

  at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year

• EORTC H&N 35

  at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year

• Numerical rating scale of pain

  at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year

Study Arms (2)

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.

Procedure: manual therapy; Procedure: Speech therapy

Control group

ACTIVE COMPARATOR

The control group will be arranged rehabilitation.

Procedure: Speech therapy

Interventions

manual therapy PROCEDURE

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.

Experimental group

Speech therapy PROCEDURE

include the stretching of the neck, facial and oral movement training, and swallowing training

Control group; Experimental group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

New Taipei Municipal Tucheng Hospital

New Taipei City, 236, Taiwan

RECRUITING

Related Publications (8)

• 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.

  PMID: 31739160 BACKGROUND

• 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.

  PMID: 31259219 BACKGROUND

• 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.

  PMID: 24936313 BACKGROUND

• 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.

  PMID: 24797251 BACKGROUND

• 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.

  PMID: 12903010 BACKGROUND

• 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.

  PMID: 31955923 BACKGROUND

• 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.

  PMID: 31041144 BACKGROUND

• 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.

  PMID: 26381894 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Musculoskeletal Manipulations; Speech Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Rehabilitation of Speech and Language Disorders; Aftercare; Continuity of Patient Care; Patient Care

Central Study Contacts

Tsung-Hsien Yang, MD

CONTACT

886-975-362-728; cgupanda@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 20, 2021
• Study Start: August 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2025
• Last Updated: March 11, 2022

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)