The Evaluation of Manual Therapy for the Prevention of Radiation-Induced Fibrosis in Patients With Head and Neck Cancer
NCT ID: NCT04850170
Last Updated: 2022-03-11
Study Results
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Basic Information
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RECRUITING
NA
70 participants
INTERVENTIONAL
2021-08-01
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
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).
PREVENTION
NONE
Study Groups
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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.
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.
Speech therapy
include the stretching of the neck, facial and oral movement training, and swallowing training
Control group
The control group will be arranged rehabilitation.
Speech therapy
include the stretching of the neck, facial and oral movement training, and swallowing training
Interventions
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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.
Speech therapy
include the stretching of the neck, facial and oral movement training, and swallowing training
Eligibility Criteria
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Inclusion Criteria
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
2. With post-radiation dermatitis at neck or shoulder
3. Current pregnancy or lactation
4. Life expectancy of \< 12 months.
20 Years
ALL
No
Sponsors
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Chang Gung Memorial Hospital
OTHER
Responsible Party
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Locations
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New Taipei Municipal Tucheng Hospital
New Taipei City, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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CMRPVVL0081
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
202002052A3
Identifier Type: -
Identifier Source: org_study_id
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