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

Chang Gung Medical Foundation

Status: Enrolling

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

Treatments: Procedure: Speech therapy; Procedure: manual therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04850170

202002052A3

CMRPVVL0081 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Experimental group

Experimental group

Description:

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.

Treatment:

Procedure: manual therapy

Procedure: Speech therapy

Control group

Active Comparator group

Description:

The control group will be arranged rehabilitation.

Treatment:

Procedure: Speech therapy