Clinical trial NCT04850170: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Radiation-Induced Fibrosis in Patients With Head and Neck Cancer
Keywords: Head and neck cancer
Post-radiation fibrosis
Manual therapy
Rehabilitation
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2021-04-20
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Change from Baseline range of motion, neck at the 3rd month
timeFrame: baseline and 3rd month
measure: Change from Baseline Functional oral intake scales at 3rd month
timeFrame: baseline and 3rd month
Secondary outcomes:
measure: range of motion, shoulder
timeFrame: measure the range of motion at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year
measure: Width of mouth opening
timeFrame: at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year
measure: EORTC QLQ C30
timeFrame: at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year
measure: EORTC H&N 35
timeFrame: at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year
measure: Numerical rating scale of pain
timeFrame: at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year
measure: Swallowing Video Fluoroscopy
timeFrame: at baseline, the 6th month, and the 12th month
measure: Change from Baseline range of motion, neck at the the 6th month
timeFrame: baseline and 6th month
measure: Change from Baseline range of motion, neck at the the 12th month
timeFrame: baseline and 12th month
measure: Change from Baseline range of motion, neck at the the 2nd year
timeFrame: baseline and 2nd year
measure: Change from Baseline range of motion, neck at the the 3rd year
timeFrame: baseline and 3rd year
measure: Change from Baseline Functional oral intake scales at 6th month
timeFrame: baseline and 6th month
measure: Change from Baseline Functional oral intake scales at 12th month
timeFrame: baseline and 12th month
measure: Change from Baseline Functional oral intake scales at 2nd year
timeFrame: baseline and 2nd year
measure: Change from Baseline Functional oral intake scales at 3rd year
timeFrame: baseline and 3rd year
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: New Taipei Municipal Tucheng Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.